Single-center Pilot Research Articles

Cohort-based nomogram for forensic prediction of SCD: a single-center pilot study.

Forensic diagnosis of sudden cardiac death (SCD) is an extremely important part of routine forensic practice. The present study aimed to develop and validate nomograms for predicting the probability of SCD with special regards to ischemic heart disease-induced SCD (IHD-induced SCD) based on multiple autopsy variables. A total of 3322 cases, were enrolled and randomly assigned into a training cohort (n = 2325) and a validation cohort (n = 997), respectively. Prediction models of SCD and IHD-induced SCD were developed through multivariable logistic regression based on variables selected by LASSO regression or ridge regression, and prediction model with higher area under the curve (AUC) of the receiver operating characteristic (ROC) curve in the validation cohort was used to establish nomograms. For SCD prediction, discrimination of the nomogram was determined based on the ROC with AUC of 0.751 (95% CI, 0.726-0.775) and 0.735 (95% CI, 0.696-0.774) in the training cohort and validation cohort respectively. The AUC of IHD-induced SCD prediction nomogram in the training cohort and validation cohort were 0.742 (95% CI, 0.716-0.768) and 0.738 (95% CI, 0.698-0.777). To facilitate the use of nomograms in routine casework in forensic practice, web calculators ( https://forensic.shinyapps.io/Forensic_SCD/ , https://forensic.shinyapps.io/Forensic_IHDinducedSCD/ ) were constructed. In conclusion, the present study developed and validated simple and practical nomograms for predicting the probability of SCD and IHD-induced SCD based on multiple autopsy variables. The nomograms have certain efficiency for discrimination and calibration to provide a novel approach to diagnose cause of death, and may become a valuable tool in forensic practice.

A retrospective single-center pilot study of the genetic background of the transplanted kidney.

Renal cell carcinoma (RCC) is one of the most prevalent cancers in kidney transplant recipients (KTR). The hereditary background of RCC in native kidneys has been determined, implicating its clinical importance. This retrospective single-center pilot study aimed to identify a potential genetic predisposition to RCC of the transplanted kidney and outcome in KTR who underwent single kidney transplantation between January 2000 and December 2020 and manifested RCC of the transplanted kidney. Next-generation sequencing (NGS) based germline genetic analysis from peripheral blood-derived genomic DNA (gDNA) was performed in both the recipient and donor using a gene panel targeting 226 cancer predisposition genes. The calculated incidence of RCC of the transplanted kidney among 4146 KTR was 0.43%. In fifteen KTR and donors, NGS was performed. The mean KTR age at transplantation and the diagnosis of RCC was 50.3 years (median 54; 5-67 years) and 66 years (median 66; 24-79 years), respectively. The mean donor age at transplantation and graft age at RCC diagnosis was 39.7 years (median 42; 7-68 years) and 50.2 years (median 46; 20-83 years), respectively. The mean follow-up after RCC diagnosis was 47 months (median 39.1; 0-112 months). Papillary RCC was the most prevalent (n = 8), followed by clear cell RCC (n = 6) and unspecified RCC (n = 1). Thirteen RCCs were low-stage (pT1a/b) diseases, one was pT3, and one was of unknown stage. Most RCC was higher graded. No germline pathogenic cancer-predisposition variant was found in either KTR or donors except for several variants of uncertain significance. RCC of the transplanted kidney is very rare. Germline cancer-predisposition testing has identified several variants of uncertain significance, but no germline genetic predisposition to graft RCC in KTR. Further research is needed to assess the clinical relevance of genetic testing for cancer risk in KTR.

Effectiveness and Safety of Polydioxanone Thread Embedding Acupuncture Compared with Acupuncture Treatment for Knee Osteoarthritis: a Protocol for a Pilot, Assessor-Blinded, Randomized Controlled Trial.

Knee osteoarthritis (OA) is a common degenerative joint disease in aging populations. Knee OA is difficult to cure and requires ongoing management. Thread embedding acupuncture (TEA) is a popular Korean medical treatment for knee OA. However, clinical evidence of its effectiveness and safety is insufficient. This study aims to evaluate the effectiveness and safety of TEA compared with acupuncture for knee OA. A two-group, two-arm, parallel, single-center, randomized, controlled, and assessor-blinded pilot trial will be conducted. A total of sixty patients aged between 40 and 85 years old will be recruited. The TEA group will receive four sessions of TEA treatment over 4 weeks. The acupuncture group will receive eight sessions of acupuncture treatment over 4 weeks. A follow-up assessment will be conducted in week 8 for both groups. Assessments will be performed at baseline, 2 weeks, 4 weeks, and 8 weeks. The primary outcome will be the mean change in the visual analog scale between the two groups at 4 weeks. The secondary outcomes will be the mean change in the Korean Western Ontario and McMaster Universities Osteoarthritis Index, knee range of motion, EuroQol 5-Dimension, patient global impression of change, and dosage of rescue medication. Statistical analysis will be conducted and the level of significance will be achieved in each variables. The results will be published in a peer-reviewed journal. This study provides a rationale for the effectiveness and safety of TEA for knee OA by comparing TEA treatment with acupuncture.

Erythrocytes and Platelets Autotransfusion in High Hemorrhagic Risk Cardiac Surgery: A Single-Center Pilot Analysis of the Multicentric SEPIA Registry.

Erythrocytes and Platelets Autotransfusion in High Hemorrhagic Risk Cardiac Surgery: A Single-Center Pilot Analysis of the Multicentric SEPIA Registry.

Weight loss in patients on osimertinib for metastatic EGFR-mutant non-small cell lung cancer.

Cachexia is characterized by weight loss and decline in muscle mass and function and is a poor prognostic factor among patients with cancer. Patients with metastatic EGFR-mutant non-small cell lung cancer (NSCLC) derive remarkable survival benefits with osimertinib, a third-generation EGFR tyrosine kinase inhibitor. It is not known whether patients treated with osimertinib experience any weight loss or whether weight loss impacts patient outcomes. Therefore, we sought to describe the frequency and consequences of weight loss in this patient population. We conducted a single-center retrospective pilot study of 56 patients treated with first-line osimertinib for metastatic EGFR-mutant NSCLC. We defined on-treatment weight loss as a loss of ≥5% body weight at 6 or 12 months of treatment. We described the characteristics of patients with and without on-treatment weight loss and differences in progression-free survival (PFS), time on treatment with osimertinib, and overall survival (OS). Forty-six percent (n = 26) of patients met the criteria for on-treatment weight loss. There were no significant differences in patient or disease characteristics between patients with and without weight loss. Compared to patients without weight loss, patients with weight loss had similar PFS and time on treatment with osimertinib. Yet, patients with weight loss had significantly worse overall survival (HR 4.91, 95% CI, 1.56-15.5, P = .007). Weight loss was observed in nearly half of patients with metastatic EGFR-mutant NSCLC treated with osimertinib, and patients with weight loss had significantly worse overall survival.

Optimizing Healthcare: Implementation of a Pharmacist-To-Pharmacist Transitions of Care Pilot Program.

Background: Transitions of care (TOC) is defined as the movement of patients between healthcare practitioners, settings and home. Ineffective TOC can lead to hospital readmissions, increased costs, and patient dissatisfaction. Pharmacists have a unique opportunity to ensure that continuity of care, in regard to medication optimization and education, is continued throughout the transition between settings. With both inpatient and ambulatory pharmacists supporting smooth discharge for hospitalized patients, an opportunity was identified to implement a pharmacist-to-pharmacist TOC program at Ascension Genesys Hospital (AGH). Objective: Implement a pharmacist-to-pharmacist TOC program at AGH. Methods: This was a single-center pilot program in which a pharmacist-to-pharmacist TOC program was implemented at AGH between January 1st and April 30th, 2024. Patients were included if they were 18 years of age and older, managed by the family medicine (FM) team, and had at least 5 medications at discharge. The FM and ambulatory pharmacists provided recommendations and all medication related problems (MRPs) and interventions were documented. Descriptive analysis was conducted. Results: A total of 25 hospitalized patients and 10 follow-up patients were included. A total of 44 inpatient MRPs and 41 outpatient MRPs were recorded. The most common inpatient MRP was antibiotic stewardship. The most common clinic MRP was medication access barrier. Conclusion: Implementation of the pilot program occurred and results were reported. These results demonstrate the importance of pharmacist involvement in TOC.

Aromatherapy with tanxiang prescription for mild to moderate anxiety: a randomized controlled pilot trial

Objective: To investigate the feasibility and preliminary effectiveness of Tanxiang Prescription (TXP) ointment for alleviating mild to moderate anxiety. Methods: A single-center pilot trial was conducted. Participants were randomly assigned to the experimental group or the control group. The experimental group received TXP treatment and health education, while the control group only received health education. The study evaluated the feasibility based on recruitment, retention, adherence, and adverse events. The primary outcome was assessed using the Self-Rating Anxiety Scale (SAS), while the secondary outcomes were evaluated using the Self-Rating Depression Scale (SDS) and Pittsburgh Sleep Quality Index (PSQI). Assessments were conducted at baseline, week 2, and week 4. Results: 58 participants were successfully enrolled, with 56 in all have finished whole research, which illustrating a recruitment rate of 33.7%, a randomization rate of 100%, and a loss rate of 3.57% in this study. No adverse events were observed. Both the experimental (n=29) and control (n=29) groups showed a significant decrease in SAS, SDS, and PSQI scores in comparison to their baseline scores at week 4 (P<0.05). Additionally, the experimental group showed significantly greater reductions in SAS, SDS, and PSQI scores than those in the control group at week 4 (P<0.05). Conclusions: TXP may be a promising treatment option for mild to moderate anxiety, offering a duel benefit of alleviating depression and promoting better sleep without any adverse effects. This study also references the effectiveness of Traditional Chinese Medicine aromatherapy for anxiety management. Further pharmacological and clinical studies are needed to observe the impact of TXP on emotional regulation in patients with anxiety.

FC26 The MEditerranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis (METRED-P) study: an interim analysis of the first UK-based diet intervention trial

Abstract There is no dietary guidance for people living with psoriasis in the UK, and evidence from randomized controlled trials (RCTs) is lacking. To address the knowledge gap on the efficacy of anti-inflammatory interventions such as the Mediterranean diet (MD) and Time-Restricted Eating (TRE), the MEditerranean Diet and Time-Restricted Eating Dietary interventions for Psoriasis (METRED-P) study aimed to examine the feasibility and collect pilot data subject to an MD, MD with TRE, or a TRE diet on psoriasis severity, life quality, and body composition. The METRED-P study (NCT05820698) was a single-centre parallel-arm feasibility pilot trial recruiting participants between June 2023 and July 2024. Inclusion criteria consisted of a psoriasis area and severity index (PASI) >5, body mass index (BMI) of 20–40 kg/m2, no systemic treatments (or on stable systemic treatments >6 months), and no underlying conditions. Participants were randomized by variance minimization to a TRE diet (10-h eating with 14-h fasting), an MD (rich in fruits, vegetables, whole-grains, fish, olive oil, and nuts) or an MD with TRE, and attended clinic visits at baseline and 12 weeks for repeat measures. Psoriasis severity was assessed with the PASI, life quality with the Dermatology Life Quality Index (DLQI), and body composition with the Tanita® scale. Twenty-four participants (60% female and 40% male) enrolled in the METRED-P study, and 10 participants completed the study to date. Participants reported a mean (SD) age of 44 (10) years, BMI of 28 (6) kg/m2, and baseline PASI of 10 (4). One-way analysis of variance showed statistically significant mean changes in total body fat % and in DLQI scores (P < 0.05). Post hoc analyses showed TRE improved DLQI scores compared with the MD, −11 (4) points, P < 0.05. TRE resulted in the greatest mean reductions in PASI −5 (4), compared with the MD −2 (3) and MD with TRE −1 (3), but statistical significance was not reached in this interim analysis. This is the first study clinically testing the MD and TRE in people with psoriasis. Whilst the METRED-P study is anticipated to end in October 2024, interim analyses illustrate favourable effects of TRE on life quality; an often-overlooked patient outcome. Given the ease and low cost of administration, TRE could be a consideration for people living with psoriasis. These pilot data will enable sample size calculations for fully powered RCTs to confirm these preliminary findings.

Anterior Circulation Stroke Mechanical Thrombectomy With Transradial Balloon Guide Catheter: Single-Center Pilot Study

This study evaluates the feasibility, safety, and efficiency of using a balloon guide catheter (BGC) through transradial access (TRA) for mechanical thrombectomy (MT) in patients with anterior circulation strokes. A retrospective case series of patients who underwent MT using BGC through TRA for acute ischemic stroke in the anterior circulation was conducted. Data collected included procedural times (from puncture to revascularization), technical success, complication rates, and clinical outcomes. Patients' baseline characteristics, stroke severity, and post-procedural outcomes were also analyzed. Thirty patients were included, with a mean age of 64.4 ± 13.6 years. The median admission NIHSS score was 13, and 17 % received intravenous thrombolysis before thrombectomy. Right-sided occlusions were more frequent (57 %). TRA was successful in 27 patients (90 %), with 3 (10 %) requiring conversion to femoral access. The median puncture-to-revascularization time was 32 minutes, and first-pass revascularization was achieved in 40 % of cases. A favorable TICI 2b or higher was accomplished in 97 %, with no access site complications. Hemorrhagic conversion occurred in 20 %, including one symptomatic intracerebral hemorrhage (3 %). At discharge, 57 % of patients had favorable outcomes (mRS 0-2), and by 90 days, 54 % achieved functional independence, with a mortality rate of 3 %. This case series highlights the feasibility of using BGC through TRA in MT for anterior circulation strokes, demonstrating promising safety and efficiency. Future multicenter studies with larger cohorts are necessary to compare clinical outcomes of TRA versus transfemoral access and guide standardized protocols for stroke interventions.

A Single-Center Pilot Study of Therapeutic Apheresis in Patients with Severe Post-COVID Syndrome.

After the COVID-19 pandemic, many patients have reported chronic fatigue and severe post-exertional malaise, with symptoms similar to those of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The accumulation of agonistic receptor autoantibodies targeting beta-adrenergic (β1 and β2) and muscarinic (M3 and M4) neurotransmitter receptors may play a crucial role in the pathomechanism of both ME/CFS and post-COVID conditions. Therapeutic apheresis has been suggested as an effective treatment option for alleviating and mitigating symptoms in this desperate group of patients. In this single-center pilot study, we analyzed autoantibodies in a cohort of 20 post-COVID patients before and after therapeutic apheresis. Apheresis resulted in a decline of β1 or β2 adrenergic receptor antibodies in all patients. Additionally, the majority of patients experienced a concurrent reduction in symptoms such as fatigue, physical activity restrictions, myalgia, post-exertional malaise, and concentration disorders. This study clearly demonstrates an association between autoantibodies and the clinical improvement of post-COVID patients. Even if future sham-controlled trials do not show a positive outcome, extracorporeal apheresis may still be valuable for this patient group by temporarily improving microperfusion and symptoms. Success in restoring patients to work and normal life, as observed in many individuals after therapeutic apheresis, should be recognized. Therefore, we believe that extracorporeal therapeutic apheresis, as part of a multimodal treatment, should be considered an early intervention for postinfectious syndromes in selected patients.

Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation.

To test feasibility of a randomized controlled trial (RCT) with an endpoint of time at goal anticoagulation in children on extracorporeal membrane oxygenation (ECMO) randomized to receive bivalirudin vs. unfractionated heparin. Open-label pilot RCT (NCT03318393) carried out 2018-2021. Single-center quaternary U.S. pediatric hospital. Children 0 days to younger than 18 years old supported with ECMO in the PICU or cardiovascular ICU. Randomization to bivalirudin vs. unfractionated heparin while on ECMO. Sixteen patients were randomized to bivalirudin, and 14 patients were randomized to heparin. There was no difference in the primary outcome, time spent at goal anticoagulation, for patients randomized to bivalirudin compared with those randomized to heparin. While hemorrhagic complications were similar between study groups, thrombotic complications were higher with six of 16 patients in the bivalirudin group having one or more circuit changes compared with 0 of 14 patients in heparin group (mean difference, 37.5% [95% CI, 8.7-61.4%]; p = 0.02). Patients in the bivalirudin group received less packed RBC transfusions vs. those receiving heparin (median [interquartile range], 6.3 mL/kg/d [2.5-8.4 mL/kg/d] vs. 12.2 mL/kg/d [5.5-14.5 mL/kg/d]; p = 0.02). In this single-center pilot RCT carried out 2018-2021, we found that the test of anticoagulation therapy of bivalirudin vs. heparin during ECMO was feasible. Larger multicenter studies are required to further assess the safety and efficacy of bivalirudin for pediatric ECMO.

Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot study

Endoscopic submucosal dissection (ESD) requires an injection solution to create a submucosal cushion for safe endoscopic resection. This study evaluated the safety and feasibility of a new injection solution (PuraLift) in ESD for early-stage gastrointestinal tumors. This prospective, single-arm, single-center pilot study included eleven patients with gastrointestinal neoplasms of the stomach (n=5) or colorectum (n=6) who underwent ESD. All patients underwent outpatient follow-up at week 4 to confirm the presence or absence of adverse events. All underwent protocol treatment and post-treatment follow-up. None of the adverse events were judged to have a cause-and-effect relationship with the study. Questionnaires to the operators who performed the protocol treatment and assistants who performed submucosal injections were evaluated in comparison to saline, and maintenance of mucosal lifting was long, comparable, and short (9/2/0). En bloc and R0 resections were achieved in all patients without intraprocedural adverse events. The median size of the specimens was 40 (range, 20–70) mm. The median excision time was 52 (range, 22–130) min. The median volume of PuraLift was 32 (range, 22–130) mL. No postoperative bleeding or delayed perforation was observed in any patient. The novel injectable material, PuraLift, can potentially ensure safe and feasible in ESD.

Romiplostim, low-dose rituximab and high-dose dexamethasone for newly diagnosed immune thrombocytopenia: A pilot study.

Therapies such as corticosteroids, thrombopoietin receptor agonists and immunomodulators have been consistently under the spotlight in the search for a better treatment for immune thrombocytopenia (ITP). However, none of them has been widely embraced as a new standard. In this pilot study, we investigated feasibility, safety and preliminary efficacy of romiplostim, low-dose rituximab and high-dose dexamethasone for newly diagnosed ITP. We conducted a single-centre single-arm pilot. One-month treatment adherence was 100%. The 1-month overall response rate was 92.3%. Complete response occurred in 11 (84.6%) patients. Median duration of response was 4.13 monts (range 0.2-25). No serious adverse events presented.

Short-term clinical outcomes of mirogabalin for carpal tunnel syndrome: A single-center retrospective pilot study

Aims & objectivesCarpal tunnel syndrome (CTS) is a common condition caused by compression of the median nerve, leading to neuropathic pain such as numbness and nocturnal discomfort, thus impacting daily life. Mirogabalin besylate (MGB), a novel gabapentinoid, shows promise for neuropathic pain, but its efficacy in CTS remains unclear.Therefore, this pilot study aimed to evaluate the short-term clinical outcomes of MGB for CTS. Materials & methodsThis retrospective observational study examined 21 patients with CTS who received MGB between April 2022 and March 2023. Evaluations included the Carpal Tunnel Syndrome Instrument (CTSI), Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH), and Visual Analog Scale (VAS) before and 12 weeks after treatment. The primary outcome was the change in CTSI-total. Secondary outcomes included CTSI subparts (symptom severity and functional status), Quick DASH, VAS, and adverse drug reactions (ADRs). ResultsMGB led to significant improvement in CTSI-total (p=0.022), with medium standardized response mean (SRM) and effect size (ES). CTSI-symptom severity (p<0.01) and VAS (p<0.001) also improved, showing medium SRM and ES for CTSI and large SRM and ES for VAS. No significant changes were observed in CTSI-functional status (p=0.349) or Quick DASH (p=0.102). ADRs occurred in 42.9 % of patients, mostly mild. ConclusionsMGB demonstrated significant short-term efficacy in improving CTS symptoms and reducing pain, though mild ADRs were common. Further studies are needed to assess long-term outcomes and compare MGB with other treatments. Levels of evidenceLevel IV.

Oral ketamine for acute postoperative analgesia (OKAPA) trial: A randomized controlled, single center pilot study

Study objectiveAlthough opioids represent the mainstay of treating surgical pain, their use is associated with significant side effects. There is an urgent need to find new pain relievers with safer side effect profiles. One drug that has been receiving increasing attention is ketamine. By using the oral route of administration, ketamine could potentially be used by patients in a less resource-intensive manner with similar efficacy. This study aims to examine the role of oral ketamine in improving recovery after major spine surgery. DesignA prospective, single-center, double blinded parallel arm, placebo controlled randomized feasibility trial. SettingToronto Western Hospital (TWH), UHN, Toronto, Canada. PatientsAdult patients (aged 18–75) undergoing multi-level lumbar spine decompression and fusion with planned overnight admission in hospital. InterventionsStudy treatment (oral ketamine 30 mg) or matching placebo for three days (nine doses total) or until hospital discharge. MeasurementsThe primary outcome was the patient-reported Quality of Recovery-15 score (QoR-15). Secondary outcomes were opioid use, pain intensity, pain interference (PROMIS-pain interference questionnaire), mood (PHQ-9) and, side-effects (Generic Assessment of Side Effects Scale). Main resultsData from 35 patients were analyzed, of which 18 patients in the ketamine group and 17 patients in the placebo group. There were no significant differences identified in QoR-15 scores at postoperative days 1,3,7, and 30. There were also no significant differences found in pain intensity scale scores at postoperative days 1, 3, 7, and 30, and PROMIS and PHQ-9 scores at postoperative days 7 and 30. Significantly less oral opioids were used in the ketamine group compared to the placebo group on postoperative day 3 and by postoperative day 7. In addition, patients in the ketamine group spent significantly less days on oral opioids and trended to be discharged from hospital earlier. ConclusionThis pilot study demonstrated that low dose oral ketamine can be safely used as an adjunct in postoperative pain treatment to help reduce opioid consumption after major spine surgery.

166Ho-RadioEmbolizaTiOn Using personalized prediCtive dosimetry in patients with Hepatocellular carcinoma: A prospective, single-centre study (RETOUCH).

Holmium-166 (166Ho) radioembolization could offer a more individualized approach in terms of imaging and dosimetry. We aim to evaluate the feasibility and safety of 166Ho selective internal radiation therapy (SIRT) using a higher tumour dose than previously administered determined by 166Ho-scout as a surrogate marker in HCC patients. This is an open-label, prospective, non-randomized, single-centre pilot study that included patients with HCC that received 166Ho-SIRT if the work-up using 166Ho-scout showed a tumour-absorbed dose ≥150 Gy, a non-tumoural liver absorbed dose less than 60 Gy and a lung absorbed dose less than 30 Gy. Primary endpoints were feasibility and safety-toxicity profiles at 24-48 h and 1 month. Overall response rates (ORR) at 3 months (mRECIST, RECIST 1.1 and metabolic response by FDG and choline PET CT) and time to progression (TTP) represented the secondary endpoints. Fifteen patients with large tumours (mean diameter 55.67 ± 28.42 mm) received 17 166Ho-SIRT treatments between July 2020 and June 2022. All the attempted treatments were accomplished. Mean administered tumour dose was 183.18 ± 71.71 Gy, while non-tumour liver dose was 30.29 ± 14.56 Gy. Median time of follow-up was 12 months (IQR 9-16). Only grade 1-2 clinical and biological AEs were observed. There were no liver decompensations. At 3 months, objective response was achieved for all target lesions (CR 78.57%, PR 21.43% according to mRECIST). Median TTP was 18.8 (range 2.9; n.e.) months. Personalized 166Ho-SIRT with a tumour delivered dose ≥150 Gy was feasible and safe for HCC patients with promising response rates.

A pilot study of novel ultrahigh-frequency dorsal root ganglia stimulation for chronic lower limb pain: Focusing on safety and feasibility.

This single-arm, open-label, single-center observational pilot study assessed the safety and efficacy of ultrahigh-frequency dorsal root ganglia (UHF-DRG) stimulation in patients with chronic leg pain with or without low back pain. Such high-frequency electrostimulation had not been conducted in the human central nervous system previously. The primary objective was to evaluate the safety of UHF-DRG stimulation (2 Hz pulses with 50 msec pulse-width and 500 kHz intrapulse sine waves, 5-min duration per stimulation) by identifying incident adverse events (AE) and severe adverse events (SAE) during the trial. The secondary objectives included assessment of pain reduction using a numerical rating score (NRS), presence of paraesthesia, and changes in four pain medications (weak opioids, anticonvulsants, antidepressants, and non-steroid-anti-inflammatory drugs). One DRG lead was implanted for one day then removed, and the patients received maximal three times of UHF stimulation in total. The study focused on ten cases. Two of them did not complete the study due to difficulty of lead implantation. There was no SAE in this trial. Among the ten cases, AEs occurred in eight, three experienced injection-related local pain and one of them had a post-dural-puncture headache, others had symptoms un-related to implantation procedure or UHF stimulation. The average NRS was reduced from 6.4 ± 1.1 at baseline to 2.9 ± 1.1 on the second-day post-implantation, and it was striking that the NRS was maintained at 3.6 ± 2.8 until 2 days after lead removal. The results showed a trend of lower frequency in medication use for all types of analgesics. In this first-in-human pilot study, we discovered that intermittent pulsed UHF-DRG stimulations ameliorated chronic lower limb pain for an extended period in humans. Our finding opens up a new neuromodulatory concept and may initiate a novel paradigm for treating intractable pain.

Safety and feasibility of single-incision robotic totally extra-peritoneal repair for inguinal hernia using the da Vinci Xi platform: a single-center prospective pilot study.

This study aimed to report the safety and feasibility of single-incision robotic totally extra-peritoneal repair (TEP) with the da Vinci Xi platform. We prospectively included patients with unilateral inguinal hernia who underwent elective single-incision robotic TEP between August 10, 2021 and December 12, 2022. The primary outcome was the determination of postoperative complications, and secondary outcomes were quality of life and recurrence rate. Twenty patients were included in this study. The median age of patients was 60 (interquartile range [IQR], 44.8-62) years, and most were male (90%). Eighteen patients had an indirect hernia. The median total operative time was 70 (IQR, 60.5-82.0) min, the median docking time was 5 (IQR, 3.3-6.0) min, and the median console time was 42 (IQR, 30.3-49.8) min. No postoperative complications occurred within six months postoperatively. We observed an upward trend in quality of life, which was low preoperatively, with improvement noted one month postoperatively. During the six-month follow-up period, there were no cases of recurrence. For uncomplicated inguinal hernias, single-incision robotic TEP using the da Vinci Xi platform can be selectively and safely attempted.

A peer support intervention in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): The STEPP randomized pilot trial design and methods

BackgroundDespite the association between peer support interventions and improved patient-reported outcomes (PROs) across cancer populations, there is a lack of structured peer support interventions for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT). ObjectiveTo test the feasibility, acceptability, and preliminary efficacy of a novel five-session, phone-delivered peer support intervention (STEPP: Supporting Transplant Experiences with Peer Program) for improving quality of life (QOL) and reducing psychological distress in patients undergoing HSCT. MethodsThis single-center pilot randomized clinical trial (RCT) will compare the STEPP intervention to usual transplant care among 90 patients hospitalized for HSCT. Eligible participants include adults (age ≥ 18 years) with hematologic malignancies hospitalized for autologous or allogeneic HSCT. The STEPP intervention provides informational, emotional, and practical support. To test the primary aim of intervention feasibility, we have established a priori benchmarks of 60 % enrollment of eligible patients and 60 % completion of at least 3 out of 5 intervention sessions among those randomized to STEPP. Acceptability will be assessed using the Client Satisfaction Questionnaire, with scores ≥3.0/4.0 indicating greater intervention acceptability. To test the secondary aim of preliminary efficacy, we will examine changes in PROs (e.g., anxiety symptoms and QOL) from pre- to post-intervention. DiscussionThis pilot RCT of a structured, phone-delivered peer support intervention tailored to the needs of patients preparing to undergo HSCT will elucidate the feasibility, acceptability, and preliminary efficacy of the STEPP intervention. We will then be poised to conduct a future, full-scale RCT to establish the efficacy of STEPP on patient outcomes.ClinicalTrials.gov: NCT 06010017.

Early minimally invasive image-guided eNdoscopic evacuation of iNTracerebral hemorrhage: a phase II pilot trial.

Whether minimally invasive endoscopic surgery (ES) improves survival and functional outcome in people with spontaneous supratentorial intracerebral hemorrhage (SSICH) is unknown. This is a single-center pilot study performed between July 2021 to January 2023. Any supratentorial hematoma with a volume between 20 mL and 100 mL was endoscopically evacuated within 24 h after bleeding onset. Participants were followed-up for 6 months, assessing clinical and radiological outcomes. The primary feasibility outcome was satisfactory hematoma removal (<15 mL residual volume on the first postinterventional CT study) and the primary efficacy outcome was reaching a modified Rankin Scale 0-3 (mRS) at 6 months. Secondary outcomes were mortality and morbidity rates. Ten participants (median age 72.5 years [IQR 67-81], 70% male, median baseline hematoma volume 34.1 [IQR 25.5-58.0]) were included. Satisfactory hematoma evacuation was achieved in 70% (7/10) with a median evacuation percentage of 69.5% [IQR 45.3-93.9%]. The median duration of surgery was 91 min [IQR 73-111]. Favorable outcome at 6 months was observed in 60% of the participants and improved from within 24 h before the intervention to the last follow-up (6 months). Five participants (50%) experienced a total of six complications, two recurrent bleedings, three pneumonias and one epilepsy. Mortality rate was 30%, while one participant died from pneumonia, one from a recurrent bleeding, and one participant due to a glioblastoma. ES appears to be feasible, with satisfactory hematoma removal being achieved in the majority of participants. Based on the descriptive results of this pilot trial, a national multicenter RCT comparing ES to best medical treatment is currently ongoing. https://clinicaltrials.gov/, identifier NCT05681988.