Single-center Prospective Trial Research Articles

The Impact of Combined Chemotherapy and Intra-Tumoural Injection of Phosphorus-32 Microparticles on Vascularity in Locally Advanced Pancreatic Carcinoma

Background: Poor intra-tumoural vascularity contributes to a lack of response to chemotherapy in pancreatic cancers. Preliminary data suggest that the addition of endoscopic ultrasound (EUS)-guided intra-tumoural injection of phosphorus-32 (32P) microparticles to standard chemotherapy is potentially beneficial in locally advanced pancreatic cancer (LAPC). We aimed to assess changes in pancreatic tumour vascularity following 32P implantation, using contrast-enhanced EUS (CE-EUS). Methods: This was a prospective single-centre trial from January 2022 to 2024 of patients with unresectable, non-metastatic LAPC undergoing standard FOLFIRINOX chemotherapy and 32P implantation. We performed CE-EUS pre-implantation after two chemotherapy cycles and 4 and 12 weeks after implantation. Time–intensity curves were analysed for 90 s after IV contrast bolus to ascertain peak intensity and intensity gain. Results: A total of 20 patients underwent 32P implantation, with 15 completing 12-week follow-up. The technical success of 32P implantation was 100%. The median primary tumour size reduced from 32 mm (IQR 27.5–38.75) pre-implantation to 24 mm (IQR 16–26) 12 weeks post-implantation (p < 0.001). Five patients (25%) had tumour downstaging, and four underwent resections. The baseline (pre-implantation, post-chemotherapy) median intensity gain of contrast enhancement within the tumour was 32.15 (IQR 18.08–54.35). This increased to 46.85 (IQR 35.05–76.6; p = 0.007) and 66.3 (IQR 54.7–76.3; p = 0.001) at 4 weeks and 12 weeks post-implantation, respectively. Over a median follow-up of 11.2 months (IQR 7.8–12.8), 15/20 (75%) of patients remained alive, with 3/20 (15%) demonstrating local disease progression. Overall survival was not significantly different between patients with or without an increased intensity of 10 a.u. or more at 12 weeks post-implantation. Conclusion: This is the first clinical study to demonstrate treatment-induced increased vascularity within pancreatic primary tumours, which followed 32P implantation and FOLFIRINOX chemotherapy. Larger comparative trials are warranted.

Cost-effectiveness of radiofrequency ablation versus percutaneous ethanol injection for early hepatocellular carcinoma in a resource-poor setting: a randomized trial.

This study assessed the cost-effectiveness of radiofrequency ablation compared with percutaneous ethanol injection in patients with early hepatocellular carcinoma in relation to the objective response rate and costs related to the procedure. This was a prospective single-center randomized trial. The primary outcome was cost-effectiveness. Secondary outcomes were the complete response rate according to the modified response evaluation criteria in solid tumors 60 days after randomization and the complication rate within 180 60 days. Fifty patients were placed into the following groups: percutaneous ethanol injection (n=23) and radiofrequency ablation (n=27). Fifty-four nodules were randomized (mean follow-up: 205.37 days). The estimated mean hospital cost was US$ 1854.11 and US$ 2770.96 for the Radiofrequency Ablation and Percutaneous Ethanol Injection Groups, respectively. The incremental cost-effectiveness ratio was US$ -2674.59, which is advantageous for radiofrequency ablation. After 60 d, 28 of 29 nodules in the Radiofrequency Ablation Group achieved complete response versus 12 of 22 in the Percutaneous Ethanol Injection Group (RD, 42.01 [95%CI= 20.55-63.24]; p<0.001). Only four early complications were observed among patients treated by percutaneous ethanol injection (p<0.05). Late complications occurred in two and one patient(s) in the Radiofrequency Ablation and Percutaneous Ethanol Injection Groups (p>0.05), respectively. Radiofrequency ablation was more cost-effective and achieved higher complete response and lower complication rates than the Percutaneous Ethanol Injection Group within this cohort. NCT06450613.

Evaluation of the outcomes of fistulotomy with primary sphincter reconstruction in the management of high trans-sphincteric fistula and supra-sphincteric fistula-in-ano : Asingle-center prospective cohort study.

Supra-sphincteric and high trans-sphincteric fistula are very challenging procedures for both the patient and the surgeon. We aimed to evaluate the outcomes of anal sphincter repair in the management of supra-sphincteric and high trans-sphincteric fistula-in-ano in terms of postoperative wound infection, bleeding, incontinence to flatus or stool, and recurrence within 1year. This single-center prospective cohort trial conducted from June 2020 to December 2023 at the Ain Shams University Hospitals included 20patients who presented with supra-sphincteric or high trans-sphincteric fistula. There were nine (45%) male and11 (55%) female patients, with a mean age of 41.5years postoperatively. The mean duration of the procedure was 90.3 min (SD ± 11.9). During the first 2weeks,ten (50%) patients scored their postoperative pain as mild, eight (40%) as moderate, and two (10%) as severe. Wound infection occurred in two (10%) patients and postoperative bleeding in three (15%) patients in the form of spotting after defecation. There were no cases of incontinence to stool. However, there were three (15%) cases of incontinence to gases. There were two cases (10%) of recurrence at the 1‑year follow-up. Postoperative patient satisfaction was assessed on a 5‑point Likert scale after 2weeks: One patient (5%) was very dissatisfied, three (15%) patients were dissatisfied, andtwo (10%) patients were unsure, while five (25%) patients were satisfied and nine (45%) were very satisfied. Immediate sphincter repair in supra-sphincteric and high trans-sphincteric fistula through a lay-open procedure was determined to be safe, easier than classic operations, and associated with alow incidence of recurrence at the 1‑year follow-up and ahigh quality of life.

Efficacy of a Modified Post-Transplant Cyclophosphamide Regimen for Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients with Severe Aplastic Anemia: A Prospective Study

The aim of the present study was to examine the efficacy of the modified post-transplant cyclophosphamide (PTCy) regimen, which involved reducing the Cy dose to 40 mg on days +3 and +4 in patients with severe aplastic anemia (SAA) subjected to unrelated donor allogeneic hematopoietic stem cell transplantation (URD-HSCT). For this purpose, a prospective single-center trial was conducted and the clinical outcomes were collected from 30 patients with SAA treated with the modified PTCy regimen for URD-HSCT. The median time to neutrophil and platelet engraftment was 13 days (range, 11 to 16) and 12 days (range, 5 to 33), respectively. The cumulative incidence of neutrophil and platelet engraftment was 93.1% ± 0.3% and 96.6% ± 0.2%, respectively. The 2-year overall survival (OS) was 97% (95% confidence interval [CI]: 90%-100%] and 2-year graft-versus-host disease (GVHD) and rejection-free survival (GRFS) was 93% (95% CI: 85%-100%). The incidence rates of acute GVHD (aGVHD) and chronic GVHD (cGVHD) were 13.8 ± 0.4% and 10.3 ± 0.3%, respectively, and no patients developed grades III-IV aGVHD. However, only one patient developed a moderate extensive cGVHD. The incidence of reconstitution varies among different subsets of immune cells after URD-HSCT. Natural killer (NK) cells recover first, followed by CD8+ T and CD19+ B cells, and finally CD4+ T cells. In conclusion, the present study demonstrates that the modified PTCy regimen, with a reduced dose of 40 mg on days +3 and +4, may be an effective regimen for URD-HSCT in patients with SAA and reduce the occurrence of the GVHD.

P-595 Increased clinical pregnancy rates using a clinical decision support tool - a retrospective cohort study

Abstract Study question Does using a clinical decision support tool, Opt-IVF, to guide hormone dosing during superovulation yield increased clinical pregnancy rates in routine clinical practice? Summary answer Higher clinical pregnancy rates were obtained using Opt-IVF to guide stimulatory hormone dosing during superovulation. What is known already ART success rates and cost depend heavily on the superovulation stage of the cycle. Two prospective single-center trials and one prospective multi-center trial had shown that using Opt-IVF to guide dosing resulted in increased numbers of high-quality embryos, used lower hormone doses, and required less ultrasound testing. This is a retrospective cohort study of the use of Opt-IVF in clinical practice over 12 months compared with the control cohort from the previous 12 months. Study design, size, duration Design: The study examined patients undergoing an IVF cycle using Opt-IVF in a single center for 12 months. Opt-IVF was used in all patients who presented to one of the investigators at Akanksha Hospital during the study period. As a comparison group, we examined patients from the previous 12 months when Opt-IVF was not used, and standard clinical protocols were followed to guide dosing. Duration: The study was conducted over 24 months Participants/materials, setting, methods 204 women aged 25-45 years underwent superovulation using hormone doses suggested by Opt-IVF (intervention). Of the participants, 19% were poor responders, 74% were below 35 years of age, 19% were 35-39 years of age, and 7% were above 39 years of age. The control group included 207 women, of whom 10% were poor responders. 72% were below 35 years of age, 26% were 35-39 years, and 2% were above 39 years of age. Main results and the role of chance The participants in the intervention group required significantly lower cumulative gonadotropin dosage compared to the control group during their controlled ovarian stimulation cycles (p &amp;lt; 0.0001). The average number of total embryos was 20% higher (p &amp;lt; 0.001), and the average number of good-quality embryos was 50% higher (p &amp;lt; 0.0001) in the Opt-IVF group than in the control group. Only 4.9% of cycles were canceled in the intervention group, compared to 12.9% canceled in the control group. Overall, Clinical pregnancy rates (including canceled cycles) increased from 35 % in the control group to 43% in the intervention group. The clinical pregnancy rate for poor responder patients was 39% in the Opt-IVF group but was only 16% in controls (p &amp;lt; 0.0001). Similarly, the clinical pregnancy rates were 34% in patients ages 35-39 years and 33% in patients above 39 years of age, much higher than the corresponding clinical pregnancy rates in controls (27% and 0%, respectively). Higher clinical pregnancy rates were also noted in the intervention group for normal responders and for younger patients. Limitations, reasons for caution This is a single-center retrospective cohort study. Wider implications of the findings Using Opt-IVF to guide dosing resulted in increased numbers of high-quality embryos and higher clinical pregnancy rates, particularly among older patients and poor responders. The proportions of these patients can be expected to grow in the future, so improving results in such patients is essential. Trial registration number not applicable

Clinical utility of artificial intelligence–augmented endobronchial ultrasound elastography in lymph node staging for lung cancer

ObjectiveEndobronchial ultrasound elastography produces a color map of mediastinal lymph nodes, with the color blue (level 60) indicating stiffness. Our pilot study demonstrated that predominantly blue lymph nodes, with a stiffness area ratio greater than 0.496, are likely malignant. This large-scale study aims to validate this stiffness area ratio compared with pathology. MethodsThis is a single-center prospective clinical trial where B-mode ultrasound and endobronchial ultrasound elastography lymph node images were collected from patients undergoing endobronchial ultrasound transbronchial needle aspiration for suspected or diagnosed non–small cell lung cancer. Images were fed to a trained deep neural network algorithm (NeuralSeg), which segmented the lymph nodes, identified the percent of lymph node area above the color blue threshold of level 60, and assigned a malignant label to lymph nodes with a stiffness area ratio above 0.496. Diagnostic statistics and receiver operating characteristic analyses were conducted. NeuralSeg predictions were compared with pathology. ResultsB-mode ultrasound and endobronchial ultrasound elastography lymph node images (n = 210) were collected from 124 enrolled patients. Only lymph nodes with conclusive pathology results (n = 187) were analyzed. NeuralSeg was able to predict 98 of 143 true negatives and 34 of 44 true positives, resulting in an overall accuracy of 70.59% (95% CI, 63.50-77.01), sensitivity of 43.04% (95% CI, 31.94-54.67), specificity of 90.74% (95% CI, 83.63-95.47), positive predictive value of 77.27% (95% CI, 64.13-86.60), negative predictive value of 68.53% (95% CI, 64.05-72.70), and area under the curve of 0.820 (95% CI, 0.758-0.883). ConclusionsNeuralSeg was able to predict nodal malignancy based on endobronchial ultrasound elastography lymph node images with high area under the receiver operating characteristic curve and specificity. This technology should be refined further by testing its validity and applicability through a larger dataset in a multicenter trial.

Assessing Residual Gastric Fluid Volume after Administering Diluted Oral Contrast until One Hour Prior to Anesthesia in Children: An Observational Cohort Study.

Background: Gastric fluid volume has been used as a surrogate marker for pulmonary aspiration risk in studies evaluating fasting protocol safety. This study measured residual gastric fluid volume in children using a protocol in which diluted oral contrast medium was administered up until one hour before anesthesia. Methods: This was a single-center prospective observational cohort trial of 70 children for elective abdominal/pelvic computed tomography (CT). Imaging was performed after diluted enteral contrast medium administration, beginning two hours before and ending at least one hour before induction. For each patient, gastric fluid volume was calculated using an image region of interest. The primary outcome measure was gastric fluid volume measured using the computed tomography image. Results: The median time from the end of contrast administration to imaging was 1.5 h (range: 1.1 to 2.2 h). Residual gastric volume, measured using CT was <0.4 mL/Kg in 33%; ≥0.4 mL/Kg in 67%; and ≥1.5 mL/Kg in 44% of patients. Residual gastric volumes measured using CT and aspiration were moderately correlated (Spearman's correlation coefficient = 0.41, p = 0.0003). However, the median residual gastric volume measured using CT (1.17, IQR: 0.22 to 2.38 mL/Kg) was higher than that of aspiration (0.51, IQR: 0 to 1.58 mL/Kg, p = 0.0008 on differences in paired measures). Three cases of vomiting were reported. No evidence of pulmonary aspiration was identified. Conclusions: Children who receive large quantities of clear fluid up to one hour before anesthesia can have a significant gastric residual volume.

QOL-09. EQUI AND HIPPO: A STUDY ASSESSING THE FEASIBILITY AND ACCEPTABILITY OF HORSE THERAPY FOR CHILDREN, ADOLESCENTS AND YOUNG ADULTS IN REMISSION FROM A MEDULLOBLASTOMA

Abstract INTRODUCTION Psycho-social and motor disorders are common long-term sequalae in patients treated for a medulloblastoma during childhood. They often require long-term, multidisciplinary rehabilitation and post-therapeutic care that can be difficult to maintain over time. To address this common problem, we hypothesized that a horse therapy can re-engage children in their rehabilitation. The expected benefits of the horse therapy involve both psycho-social skills thought animal mediation (equitherapy) and motor skills using the horse’s three-dimensional movement (hippotherapy). MATERIALS AND METHODS We conducted a single-center prospective interventional trial including patients treated for medulloblastoma during childhood, aged 10 to 26, in complete remission. The intervention consisted on weekly 2-hours sessions of equitherapy and hippotherapy with a specialized physiotherapist and psychologist over a 4-month period (16 sessions per patient) in groups of 2 participants. The primary objective was to determine the feasibility of a rehabilitation program combining equitherapy and hippotherapy. The secondary objective was to assess changes in motor skills, balance, emotional feelings, self-esteem and quality of life at the end of the sessions, at 4 months and at 6 months using questionnaires and standardized and validated measurements. RESULTS The study began in April 2023 and is still ongoing. Six participants were included and four ended the intervention period. On this preliminary cohort, the recruitment rate was excellent with 100% of patients offered the program agree to take part. Three participants completed the program with a 100% adherence rate. All participants were very satisfied with their participation in the program. Analysis of second objective will be presented in the form of case reports. CONCLUSION The expected outcome of this study is to define a framework for the application of this practice, enabling a model of this rehabilitative management, and then to lead to dissemination and recognition of this activity, enabling larger-scale studies.

Results of the study of factors predicting the risk of the development of grade III radiation-induced mucositis during radiation or chemoradiation therapy in patients with oral cavity and oropharynx cancer.

Today, a number of methods and ways of prevention and treatment of radiation- -induced mucositis of the oral cavity and oropharynx have been developed, but the represented approaches are still not effective enough. Therefore, to increase the effectiveness of the prevention and treatment of radiation-induced mucositis, it is necessary to approach this problem comprehensively and individually, and to evaluate the factors affecting the development of mucositis. In this single-center prospective controlled non-randomized clinical trial, the results of clinical observation of the development of complications of radiation and chemoradiation therapy in 105 patients with a newly diagnosed squamous cell cancer of the oral cavity and oropharynx were analyzed. Factors affecting the risk of the development of grade III radiation-induced mucositis including the age, gender of the patients, their general condition before the treatment according to World Health Organisation scales, type of the treatment and its doses, additional use of immunotherapy with alpha/beta defensins, characteristic signs of the tumor process and all indices of the immune status of the patients before the treatment have been analyzed. The method of construction and analysis of one-factor logistic regression models, where 24 indices were analyzed as factorial features, showed that the reduction of the risk of the development of grade III radiation-induced mucositis is predicted by several factors: immunotherapy, gender, serum concentrations of IgG and IgA. A decrease (P &lt; 0.001) in the risk of the development of grade III radiation-induced mucositis was revealed if immunotherapy with alpha/beta defensins (with a total dose of 40 mg) was included into the treatment scheme (relative odds (RO) 0.05; 95% reference interval (RI) 0.02-0.18), in comparison with patients of the groups where it was not present or this immune agent was used in a total dose of 60 mg (P = 0.001, RO 0.06; 95% RI 0.01-0.30). The next factorial sign was gender, namely the risk of the development of grade III radiation-induced mucositis was lower for men (P = 0.003; RO 0.15; 95% RI 0.04-0.53) compared to women. An increase (P = 0.024) in the risk of the development of grade III radiation-induced mucositis with an increase in the initial level of IgG serum concentration was revealed, (RO 1.08; 95% RI 1.01-1.16) for each 1 mg/mL, as well as an increase (P = 0.044) in the possibility of the appearance of grade III radiation-induced mucositis with an increase in the serum concentration of IgA (RO 1.23; 95% RI 1.01-1.50) for every 1 mg/mL also before the beginning of the treatment. Multifactorial analysis has also confirmed that the risk of the development of grade III radiation-induced mucositis increases (P = 0.008) with a high serum IgG concentration before the treatment or with an increase in this index during therapy (RO 1.13; 95% RI 1.03-1.09) for every 1 mg/mL (when standardized by other risk factors). It was determined that when standardizing according to other factors (gender, IgG level), the risk of the development of grade III radiation-induced mucositis in the use of the immune agent alpha/beta defensins in a total dose of 40 mg per course decreases (P &lt; 0.001; RO 0.08; 95% RI 0.02-0.27) compared to patients with oral cavity and oropharynx cancer who were not treated with immunotherapy. The risk of the development of grade III radiation-induced mucositis also decreases (P = 0.001) in the use of immunotherapy in a higher dose, i.e. 60 mg per course (RO 0.03; 95% RI 0.004-0.24 compared to patients whose treatment did not include immunotherapy (when standardized by other factors). As a result of this controlled clinical study, some factors were determined in addition to the radiation as those affecting the risk of the development of grade III radiation-induced mucositis in patients with oral cavity and oropharynx cancer during special treatment. These factors comprise the inclusion of immunotherapy with alpha/beta defensins into the specific treatment; gender, and baseline levels of serum IgG and IgA concentrations suggest a pattern in which the higher the serum IgG and IgA concentrations are before the start of the treatment, the greater is the likelihood of severe radiation-induced mucositis degree during special therapy. The results of the study of humoral state of the immune system in patients with oral cavity and oropharynx cancer before the beginning of chemoradiation therapy can be used as prognostic risk factors for the development of severe gamma-irradiation-induced mucositis of the oropharyngeal area, as well as an indication for the use of immunotherapeutic agents (in particular, alpha/beta defensins) that are able to polarize the immune response towards type 1 T-helpers through their immunomodulatory action.

Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift

ABSTRACT Bayesian adaptive designs with response adaptive randomization (RAR) have the potential to benefit more participants in a clinical trial. While there are many papers that describe RAR designs and results, there is a scarcity of works reporting the details of RAR implementation from a statistical point exclusively. In this paper, we introduce the statistical methodology and implementation of the trial Changing the Default (CTD). CTD is a single-center prospective RAR comparative effectiveness trial to compare opt-in to opt-out tobacco treatment approaches for hospitalized patients. The design assumed an uninformative prior, conservative initial allocation ratio, and a higher threshold for stopping for success to protect results from statistical bias. A particular emerging concern of RAR designs is the possibility that time trends will occur during the implementation of a trial. If there is a time trend and the analytic plan does not prespecify an appropriate model, this could lead to a biased trial. Adjustment for time trend was not pre-specified in CTD, but post hoc time-adjusted analysis showed no presence of influential drift. This trial was an example of a successful two-armed confirmatory trial with a Bayesian adaptive design using response adaptive randomization.

Symptom Assessment of Candidates for Sacral Neuromodulation Therapy With Urologic and Colorectal Conditions: Time for a Holistic Approach? Results and Findings From a Prospective Single-Center Study

ObjectivesSacral neuromodulation (SNM) has evolved as a therapeutic intervention for various pelvic floor dysfunctions. However, the traditional approach primarily assesses discipline-specific symptoms, potentially overlooking holistic symptom improvement. We aimed to investigate whether a more comprehensive evaluation of pelvic floor symptoms enhances the assessment of SNM’s test phase. Material and MethodsA prospective single-center trial (Optimization of Lower Urinary Tract Symptoms study) assessed SNM efficacy from March 2018 to December 2021 in patients from the urology department (UD) and colorectal surgery department (CRD) with a follow-up of 12 months. Objective and subjective outcomes were examined using diaries and patient-reported outcome measures. Statistical analyses were conducted to determine predictive factors for treatment success, expressed by the patient global impression of change. SPSS 29.0 was used. ResultsA total of 85 participants were included, displaying concomitant pelvic floor symptoms. After the first phase, significant improvements on all pelvic floor domains questionnaires were seen for both patients from UD and those from CRD. Although improvements were observed in bladder and bowel diaries, the traditional criteria for success (≥50% improvement in diary variables) did not consistently correlate with the patients' global impression of change. The absolute reductions in bother sum scores from multiple domains were significant predictors for the patients' global impression of change, outperforming discipline-specific assessments. Patients from UD benefit from both a urologic and pelvic pain symptom evaluation, and those from CRD, from both a urologic and bowel symptom evaluation. ConclusionsSNM shows positive effects across various pelvic floor domains, even beyond the primary intended indication of implantation. The rather rigid approach of patient selection of discipline-specific symptoms alone can be questioned. A more comprehensive evaluation encompassing various pelvic floor symptoms with the emphasis on subjective outcome measures could enhance SNM’s efficacy assessment during the test phase. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT05313984.

#2650 A novel approach for exit site care reduces peritoneal dialysis catheter related infections

Abstract Background and Aims Peritoneal dialysis (PD) related infections, including peritonitis and catheter related infections, are associated with significant morbidity and technique failure. Various exit site care protocols are available, most allow to shower in running water after the exit site is well healed. Following an increase in exit site infections (ESI) in our dialysis unit, partially resulting from water derived organisms, we implemented a novel exit site care protocol. The protocol included complete avoidance of water exposure using stoma bag during shower; and change in antibiotic treatment from gentamycin to mupirocin. We aimed to evaluate its efficacy to decrease ESI episodes. Method A prospective single center trial. Study group included PD patients between June 2018 - May 2021 who implemented the new exit-site care protocol. They were compared to a historical control group that included all PD patients between January 2016 to May 2018. In the control group, exit-site care included a daily shower with a bactericidal cleanser containing chlorhexidine 4%, thereafter local gentamycin 0.1% was applied with sterile gauze dressing. In the study group, water exposure during daily wash was avoided using a stoma bag sealed around the catheter exit-site and the tubing. Thereafter, the exit-site was cleaned with a chlorhexidine 0.5%- alcohol 70% solution and local mupirocin 2% was applied with a sterile gauze cover. Primary outcome was catheter related infections, including ESI and tunnel infection. Secondary outcomes were peritonitis and technique loss. Results A total of 113 patients were included, 58 patients in control and 55 in study group. Mean follow up time was 13.28 ± 9.5 months in control and 16.4 12.7 months in study group. ESI rate was significantly lower in study group (0.11/patient year) compared to control group (0.71/ patient year), p&amp;lt;0.001. Time to first ESI was significantly longer in study group, χ² (1) = 25.104, p &amp;lt; 0.001 (Fig. 1). On multivariate logistic regression analysis confirmed the protective effect of the intervention on ESI risk (p &amp;lt;0.001). Longer PD vintage and active cancer predicted ESI (p = 0.01 and 0.02, respectively). There were no tunnel infections during study period compared to 3 episodes during control. Peritonitis rate was significantly lower in study group (0.19/patient years) compared to control group (0.40/patient years), p=0.011. There was no difference in time to first peritonitis episode between groups χ² (1)=2.32, p=0.128. Nine patients were lost to PD due to PD related infection in control group, compared to 5 in study group. Peritonitis related mortality occurred in one patient in control group. Conclusion Protection of exit site from water exposure in conjunction with local Mupirocin cream reduced significantly ESI and peritonitis episodes in peritoneal dialysis patients. This protocol may be more beneficial in areas of poor water quality.

Impact of yoga on the central and peripheral vascular function among desk-based workers: A single-centered trial study

Background The aim of this study was to observe and analyze vascular function in ‘prolonged sitting’, followed by a yoga asana routine and pranayama intervention. Participants in this study include those who work from desks in offices. The study required the participants to attend on three separate days at random, and they had to finish a computerized test on each day. On the first day, participants were required to complete a computer test while sitting still for four hours (with the exception of washroom breaks). The next day, they underwent a computerized test along with a pranayama intervention. Finally, on the last day, they underwent a computerized test along with a yoga asana intervention. At the start of the study and after two and four hours, we measured the diameter and velocity of the common carotid artery (CCA) and superficial femoral artery (SFA). Methods The study was a within-subjects prospective single-center trial conducted in the Department of Radio-Diagnosis and Imaging, Kasturba Medical Hospital, Manipal, India, between September 2022 and January 2023. Participants were asked to do one of the following ‘activities’ over successive weeks: Week 1 – Prolonged sitting; Week 2 – Pranayama intervention; and Week 3 – Yoga asana intervention during prolonged sitting. The baseline and follow-up variables of pulse velocity, endothelial thickness, and shear rate were assessed for normality through a Shapiro-Wilk Test. Results Our sample included 11 participants with moderate physical activity, five with high physical activity and one with low physical activity. Yoga asana intervention comprised participants sitting continuously for four hours, with a yoga asana intervention being provided every hour, lasting for 10 minutes. Conclusions Yoga asana improves vascular functions in prolonged sitting conditions. This routine can promote the concept of interrupted sitting and ways to reduce it with efficient yoga asana practice without changing the work culture and provide better physical relief. Trial registration Clinical Trials Registry – India ( CTRI/2022/09/045628), date of registration: 19/09/2022(CTRI/2022/9/045628)https://ctri.nic.in/Clinicaltrials/main1.php?EncHid=16349.27799,

Natural History of Myocardial αvβ3 Integrin Expression After Acute Myocardial Infarction: Correlation with Changes in Myocardial Blood Flow.

Angiogenesis is an essential part of the cardiac repair process after myocardial infarction, but its spatiotemporal dynamics remain to be fully deciphered.68Ga-NODAGA-Arg-Gly-Asp (RGD) is a PET tracer targeting αvβ3 integrin expression, which is a marker of angiogenesis. Methods: In this prospective single-center trial, we aimed to monitor angiogenesis through myocardial integrin αvβ3 expression in 20 patients with ST-segment elevation myocardial infarction (STEMI). In addition, the correlations between the expression levels of myocardial αvβ3 integrin and the subsequent changes in 82Rb PET/CT parameters, including rest and stress myocardial blood flow (MBF), myocardial flow reserve (MFR), and wall motion abnormalities, were assessed. The patients underwent 68Ga-NODAGA-RGD PET/CT and rest and stress 82Rb-PET/CT at 1 wk, 1 mo, and 3 mo after STEMI. To assess 68Ga-NODAGA-RGD uptake, the summed rest 82Rb and 68Ga-NODAGA-RGD images were coregistered, and segmental SUVs were calculated (RGD SUV). Results: At 1 wk after STEMI, 19 participants (95%) presented increased 68Ga-NODAGA-RGD uptake in the infarcted myocardium. Seventeen participants completed the full imaging series. The values of the RGD SUV in the infarcted myocardium were stable 1 mo after STEMI (1 wk vs. 1 mo, 1.47 g/mL [interquartile range (IQR), 1.37-1.64 g/mL] vs. 1.47 g/mL [IQR, 1.30-1.66 g/mL]; P = 0.9), followed by a significant partial decrease at 3 mo (1.32 g/mL [IQR, 1.12-1.71 g/mL]; P = 0.011 vs. 1 wk and 0.018 vs. 1 mo). In segment-based analysis, positive correlations were found between RGD SUV at 1 wk and the subsequent changes in stress MBF (Spearman ρ: r = 0.17, P = 0.0033) and MFR (Spearman ρ: r = 0.31, P < 0.0001) at 1 mo. A negative correlation was found between RGD SUV at 1 wk and the subsequent changes in wall motion abnormalities at 3 mo (Spearman ρ: r = -0.12, P = 0.035). Conclusion: The present study found that αvβ3 integrin expression is significantly increased in the infarcted myocardium 1 wk after STEMI. This expression remains stable after 1 mo and partially decreases after 3 mo. Initial αvβ3 integrin expression at 1 wk is significantly weakly correlated with subsequent improvements in stress MBF, MFR, and wall motion analysis.

Abstract PS03-06: Clinical implementation of artificial-intelligence-assisted detection of breast cancer metastases in sentinel lymph nodes: saving costs and time (the CONFIDENT-B trial)

Abstract Background Metastases in sentinel lymph nodes (SN) of breast cancer (BC) patients are strongly associated with a worse survival and consequently guide treatment. If metastases are absent upon pathologist’ assessment of the regular hematoxylin and eosin (HE)-slide, additional immunohistochemistry (IHC)-stains are performed to ensure that no metastases are missed. However, these stains come at high additional costs, which may exceed specimen reimbursement. Fortunately, digital pathology is becoming more common, thereby creating an avenue of opportunities for artificial intelligence (AI) assistance. Although the number of studies on (promising) AI-algorithms increases exponentially, studies on actual clinical implementation are lacking. In this single-center prospective trial, we investigated to which extent an artificial intelligence (AI)-assisted clinical workflow for the detection of SN-metastases reduces IHC-use, while maintaining current diagnostic safety standards. Methods We enrolled 190 SN-specimens of 182 patients with invasive or in situ BC from September 2022 to May 2023. SN-specimens were allocated bi-weekly to either the control-arm (n=90) or the intervention-arm (n=100). In the control-arm, SN-specimens were digitally assessed according to the current clinical workflow, while pathologists in the intervention-arm assessed the SN-specimen with the output the ‘Metastasis-Detection-App’ (Visiopharm©) available. In both groups, IHC was performed in all morphologically negative cases. Main outcome was the relative risk (RR) of IHC-use per detected case of SN-metastases. Case-mix adjustment was performed by log-binomial regression. Results Overall, 59 SN-specimens contained metastases (31.1%). AI-assistance resulted in a significantly lower risk of IHC-use per detected case of SN-metastases (adjusted RR: 0.680, 95% CI: 0.347-0.878). Besides preventing IHC-use, thereby reducing costs, AI-assisted pathologists also spent significantly less time on their assessment of the SN-specimen (3m:41s vs. 6m:04s, p = 0.028). Furthermore, the sensitivity of AI-assisted pathologists was up to 30% higher. The AI-assisted pathologists missed two cases of micro-metastases in the intervention arm, one of which was in retrospect highlighted by the algorithm, while in the other case the tumor cells were located in a heavily cauterized area of the HE-slide and therefore only visible on the (serial) IHC-slides. In the control arm, the algorithm in retrospect picked up all micro- and macro-metastases and nearly half of the isolated tumor cells (ITC). In addition, all participating pathologists stated that AI was easy to use, that they felt confident using AI, and that besides saving them time, AI made their work more enjoyable. Cost reductions on IHC by AI-assistance depend on laboratory policy (i.e. when and on how many levels IHC is performed), but, at a cost of €25,- per IHC-stain, range from €1.500 to €3.500 per 100 SN’s in a scenario where IHC is performed in all morphologically negative cases. In a scenario where IHC is only performed in patients in whom finding ITC has clinical consequences (i.e. patients who received neoadjuvant treatment), cost savings on IHC range from €7.500-€12.500 per 100 SNs, depending on laboratory policy. Conclusion AI-implementation for the detection of SN-metastases in BC-patients leads to a significant reduction of IHC-use and subsequent costs, while saving pathologists time and making their work more enjoyable. Importantly, AI-implementation during this trial was safe and patients were not at risk of an inferior diagnosis. By doing this trial alone, an estimated €3,000 on IHC-use was saved. Such tangible cost savings are crucial to build a viable business case for AI implementation in diagnostic pathology. Citation Format: Carmen van Dooijeweert, Rachel Flach, Natalie ter Hoeve, Celien Vreuls, Roel Goldschmeding, Jan-Erik Freund, Paul Pham, Tri Nguyen, Elsken Van der Wall, Geert Frederix, Nikolas Stathonikos, Paul Van Diest. Clinical implementation of artificial-intelligence-assisted detection of breast cancer metastases in sentinel lymph nodes: saving costs and time (the CONFIDENT-B trial) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS03-06.

Impact of yoga on the central and peripheral vascular function among desk-based workers: A single-centred trial study

Background The aim of this study was to observe and analyze vascular function in ‘prolonged sitting’, followed by a yoga routine and pranayama intervention. Participants in this study include those who work from desks in offices. The study required the participants to attend on three separate days at random, and they had to finish a computerized test on each day. On the first day, participants were required to complete a computer test while sitting still for four hours (with the exception of washroom breaks). The next day, they underwent a computerized test along with a pranayama intervention. Finally, on the last day, they underwent a computerized test along with a yoga intervention. At the start of the study and after two and four hours, we measured the diameter and velocity of the common carotid artery (CCA) and superficial femoral artery (SFA). Methods The study was a within-subjects prospective single-center trial conducted in the Department of Radio-Diagnosis and Imaging, Kasturba Medical Hospital, Manipal, India, between September 2022 and January 2023. Participants were asked to do one of the following ‘activities’ over successive weeks: Week 1 – Prolonged sitting; Week 2 – Pranayama intervention; and Week 3 – Yoga intervention during prolonged sitting. The baseline and follow-up variables of pulse velocity, endothelial thickness, and shear rate were assessed for normality through a Shapiro-Wilk Test. Results Our sample included 11 participants with moderate physical activity, five with high physical activity and one with low physical activity. Yoga intervention comprised participants sitting continuously for four hours, with a yoga session intervention being provided every hour, lasting for 10 minutes. Conclusions Yoga improves vascular functions in prolonged sitting conditions. This routine can promote the concept of interrupted sitting and ways to reduce it with efficient yoga practice without changing the work culture and provide better physical relief. Trial registration Clinical Trials Registry – India ( CTRI/2022/09/045628), date of registration: 19/09/2022(CTRI/2022/9/045628)https://ctri.nic.in/Clinicaltrials/main1.php?EncHid=16349.27799,

Targeted axillary dissection after neoadjuvant chemotherapy for highly selective patients with initial cN1 breast cancer: A single-center prospective trial.

Sentinel lymph node (SLN) biopsy is gradually accepted as the standard of care in breast cancer patients with down-staged axillary disease after neoadjuvant chemotherapy (NAC). However, it is still difficult to precisely define pre-NAC clinical node-positive (cN1) and post-NAC clinical node-negative (ycN0). This prospective single-center trial was designed to evaluate the feasibility and accuracy of standard targeted axillary dissection (TAD) after NAC in highly selective pre-NAC cN1 patients (not considering ultrasound-based axillary ycN staging). This prospective trial included patients with initial pre-NAC cT1-3N1M0 invasive breast cancer but with a rigorous definition of cN1 from the Affiliated Cancer Hospital of Zhengzhou University. When NAC was effective (including complete and partial responses) and preoperative axillary palpation was negative, preoperative ultrasound-based axillary staging was not considered, and all patients underwent TAD followed by axillary lymph node (LN) dissection. The detection rate (DR) and false-negative rate (FNR) of TAD were calculated. A total of 82 patients were included, and 77 of them were eligible for data analysis. The DR for TAD was 94.8% (73/77). There were 26 patients with one abnormal LN at the time of diagnosis based on ultrasound, 45 patients with two, and 2 patients with three. One patient had one TAD LN, four patients had two TAD LNs, and 68 patients had three or more TAD LNs. Preoperative axillary palpation yielded negative results for all 73 patients who successfully underwent TAD. Preoperative ultrasound-based ycN0 and ycN+ conditions were detected for 52 and 21 cases, respectively. The FNR was 7.4% (2/27) for standard TAD (≥3 SLNs), which was lower than that of all successful TAD (≥1 SLN; 10.0%, 3/30). In rigorously defined pre-NAC cN1 breast cancer patients, standard TAD is feasible for those with negative axillary palpation after NAC, and FNR is also less than 10%. chictr.org.cn , ChiCTR2100049093.

Факторы риска развития рецидивов перианальных инфекционных осложнений у пациентов с опухолевыми заболеваниями системы крови: результаты одноцентрового проспективного исследования

Aim. To study risk factors for relapses of perianal infection (PI) in patients with hematological tumors.&#x0D; Materials &amp; Methods. This single-center prospective clinical trial (2016–2020) enrolled all oncohematological patients at the National Research Center for Hematology who developed PI at various stages of chemotherapy. To assess the impact of some factors on relapsing perianal infectious complications, the distribution of clinical characteristics in groups of patients with single or multiple PI episodes was analyzed.&#x0D; Results. The trial addressed 158 PI episodes in 132 patients; there were 64 men and 68 women, the median age was 40 years (range 18–77 years). PI relapses were identified in 22 (16.67 %) patients, with a higher incidence in acute myeloid leukemia (AML) patients (63.64 %). Recurrent PI episodes were usually registered on program therapy of acute leukemias (73.08 %), more often at consolidation stage (38.46 %) than at other stages of treatment (17.42 %) (hazard ratio [HR] 2.96; 95% confidence interval [95% CI] 1.19–7.35; p &lt; 0.031). With the follow-up of 360 days from the first episode, the probability of PI relapses was 16.2 %, and it was higher in AML patients (24.3 %). In non-remission AML patients having the first PI episode, the probability of PI relapses considerably increased and accounted for 52.6 %. In case of cryptogenic pararectal abscesses, it was 20 %, if solely abscess drainage was performed at the first stage. However, no relapses were registered after the surgical treatment of pararectal fistulas. The risk factors for recurrent PI, as was shown by univariate analysis, were AML diagnosis (HR 2.94; 95% CI 1.14–7.62; p &lt; 0.032) and the lack of remission of hematological tumor by the time of the first PI episode (HR 2.98; 95% CI 1.13–7.90; p &lt; 0.034). By multivariate analysis, the significant risk factor was non-remission AML diagnosis by the time of the first PI episode (HR 6.94; 95% CI 2.93–16.66; p &lt; 0.0001).&#x0D; Conclusion. The significant risk factor for PI relapses is non-remission AML diagnosis by the time of the first infectious episode. This category of patients shows the maximal probability of relapsing perianal infectious complications, which is 52.6 %. To prevent PI relapses in patients with cryptogenic pararectal abscesses, abscess drainage should be combined with scheduled surgery of anal fistulas.

Perioperative and Post-Hospital Whole-Course nutrition management in patients with pancreatoduodenectomy - a Single-Center prospective randomized controlled trial.

Whole-course nutrition management (WNM) has been proven to improve outcomes and reduce complications. We conducted this randomized controlled trial to validate its effectiveness in patients undergoing pancreatoduodenectomy. From December 1, 2020, to November 30, 2023, this single-center randomized clinical trial was conducted at the Department of Hepatobiliopancreatic Surgery in a major hospital in Beijing, China. Participants who were undergoing pancreatoduodenectomy were enrolled and randomly allocated to either the WNM group or the control group. The primary outcome was the incidence of postoperative complications. Subgroup analysis in patients who were at nutritional risk was performed. Finally, a six-month follow-up was conducted and the economic benefit was evaluated using an incremental cost-effectiveness ratio (ICER). A total of 84 patients were randomly assigned (1:1) into the WNM group and the control group. The incidences of total complications (47.6% vs. 69.0%, P=0.046), total infections (14.3% vs. 33.3%, P= 0.040) and abdominal infection (11.9% vs. 31.0%, P= 0.033) were significantly lower in the WNM group. In the subgroup analysis of patients at nutritional risk, 66 cases were included (35 cases in the WNM group and 31 cases in the control group). The rate of abdominal infection (11.4% vs. 32.3%, P= 0.039) and postoperative length of stay (23.1±10.3 vs. 30.4±17.2, P= 0.046) were statistically different between the two subgroups. In the six-month follow-up, more patients reached the energy target in the WNM group (97.0% vs. 79.4%, P=0.049) and got a higher daily energy intake (1761.3±339.5 vs. 1599.6±321.5, P=0.045). The ICER suggested that WNM saved 31,511 Chinese Yuan (CNY) while reducing the rate of total infections by 1% in the ITT population and saved 117,490 CNY in patients at nutritional risk, while WNM saved 31,511 CNY while reducing the rate of abdominal infections by 1% in the ITT population and saved 101,359 CNY in patients at nutritional risk. In this trial, whole-course nutrition management was associated with fewer total postoperative complications, total and abdominal infections, and was cost-effective, especially in patients at nutritional risk. It seems to be a favorable strategy for patients undergoing PD.

Application of enhanced recovery after surgery during the perioperative period in children with Meckel's diverticulum-a single-center prospective clinical trial.

Enhanced recovery after surgery (ERAS) has been widely used in adult surgery. However, few studies have reported the efficacy of ERAS in paediatric patients with Meckel's diverticulum (MD), the aim of the study was to prospectively evaluate the safety and efficacy of ERAS in treating MD. A prospective randomised controlled study of children with MD admitted to our hospital from Jan 1, 2021 to Dec 31, 2023 were conducted, we developed and implemented an ERAS program for this patients. All cases were strictly selected according to the inclusion and exclusion criteria. Among these patients, they were randomly assigned to the ERAS group or the traditional (TRAD) group with random number table row randomization. The main observational indicators were operation time, intraoperative hemorrhage, FLACC pain scale results on 2 h, 6 h, 12 h, 24 h after surgery, length of postoperative stay (LOPS), time to first defecation, time to first eating after surgery, time to discontinuation of intravenous infusion, total treatment cost, incidence of postoperative complications, 30-day readmission rate and parental satisfaction rate. A total of 50 patients underwent Meckel's diverticulectomy during this period, 7 patients were excluded, 23 patients were assigned to the ERAS group and 20 patients were assigned to the TRAD group. There were no significant differences in demographic data and operation time, intraoperative hemorrhage. The FLACC pain scale results on 2 h, 6 h, 12 h, 24 h after surgery were significantly lower in the ERAS group. The LOPS was 6.17 ± 0.89 days in the ERAS group and 8.30 ± 1.26 days in the TRAD group, resulting in a significantly shorter LOPS in ERAS group. ERAS could also reduce the first postoperative defecation time, the time to first eating after surgery and the time to discontinuation of intravenous infusion. The treatment cost was decreased in the ERAS group. The rate of complications and 30-day readmission were not significantly different between the two groups. In this single-center study, the ERAS protocol for patients with MD requiring surgery was safe and effective.