International Multicenter Study Research Articles

International, multicenter analysis of endoscopic full-thickness resection of duodenal neuroendocrine tumors.

Non-exposed endoscopic full-thickness resection (EFTR) using a dedicated full-thickness resection device (FTRD) can be used to perform en bloc resection of subepithelial lesions throughout the gastrointestinal tract. Here we aim to evaluate the safety and efficacy of EFTR for the management of duodenal neuroendocrine tumors (dNET). International multicenter retrospective study of device assisted EFTR for dNET. Study outcomes included rates of technical success, R0 resection, and adverse events (AE). 171 patients were included across 35 centers. Lesions had a median size of 10 mm and were in the duodenal bulb in 143 cases (83.6%). Technical success was achieved in 164 (95.9%) and R0 resection in 123 cases (71.9%). R0 resection rate for lesions located in the proximal third of the bulb was 62.0% compared to 83.9% for more distal locations (P = 0.002). R0 resection rate was not affected by lesion size or depth of invasion. On multivariable analysis, date of resection (2021 onwards) and location distal to the proximal third of the duodenal bulb were independent predictors of R0 resection, but not case volume per participating center. Follow-up information was available for 114 patients (66.7%), and demonstrated two recurrences over a median follow-up of 10 months. Severe AEs occurred in 3 patients (1.8%). EFTR of dNET showed high technical success and R0 resection rates and very low rate of severe AEs. It could become endoscopic treatment of choice for dNET, at least for lesions not within proximity of the pylorus.

Prognostic value of assessing ctDNA in patients with endometrial carcinoma - an international multicenter study.

Prognostic value of assessing ctDNA in patients with endometrial carcinoma - an international multicenter study.

Artificial intelligence-based automated surgical workflow recognition in esophageal endoscopic submucosal dissection: an international multicenter study (with video).

Endoscopic submucosal dissection (ESD) is a crucial yet challenging multi-phase procedure for treating early gastrointestinal cancers. This study developed an artificial intelligence (AI)-based automated surgical workflow recognition model for esophageal ESD and proposed an innovative training program based on esophageal ESD videos with or without AI labels to evaluate its effectiveness for trainees. We retrospectively analyzed complete ESD videos collected from seven hospitals worldwide between 2016 and 2024. The ESD surgical workflow was divided into 6 phases and these videos were divided into five datasets for AI model. Trainees were invited to participate in this multimedia training program and were assigned to the AI or control group randomly. The performance of the AI model and label testing were evaluated using the accuracy. A total of 195 ESD videos (782,488s, 9268 phases) were included. The AI model achieved accuracy of 92.08% (95% confidence interval (CI), 91.40-92.76%), 91.71% (95% CI 90.11-93.31%), and 89.84% (95% CI 87.42-92.25%) in the training, internal, and external test dataset (esophagus), respectively. It also achieved acceptable results in the external test dataset (stomach, colorectum). For the training program, the overall label testing accuracy of the AI group learning ESD videos with AI labels was 88.73 ± 2.97%, significantly higher than the control group without AI labels (81.51 ± 4.63%, P < 0.001). The AI model achieved high accuracy in the large ESD video datasets. The training program improves understanding of the complexity of ESD workflow and demonstrates the program's effectiveness for trainees.

A Combined Model of Spleen Stiffness and Baveno VII Criteria for Clinically Significant Portal Hypertension in Compensated Advanced Chronic Liver Disease: An International Multicenter Study

ABSTRACTAimsThe renewing Baveno VII consensus proposed criteria for the diagnosis of clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD). The performance of a combined model of spleen stiffness measurement (SSM) by spleen‐dedicated 100 Hz (SSM@100 Hz) or conventional 50 Hz (SSM@50 Hz) and Baveno VII criteria to rule‐in or rule‐out CSPH had not been well validated. This study aims to compare the performance of the combined model with Baveno VII criteria alone to rule‐in and rule‐out CSPH in cACLD.MethodsThis international multicenter study included cACLD patients who underwent paired liver stiffness measurement (LSM), SSM@100 Hz or SSM@50 Hz, platelet count (PLT), and hepatic venous pressure gradient (HVPG). CSPH was defined as HVPG ≥ 10 mmHg. Patients with SSM@100 Hz were prospectively recruited from China between August 2021 and March 2022, while a global cohort of patients with SSM@50 Hz from Croatia, Japan, and Singapore was retrospectively included between December 2014 and June 2022. The diagnostic performance of different models was assessed using sensitivity, specificity, positive predictive value, and negative predictive value.ResultsA total of 206 patients with cACLD were recruited from seven university centers and 110 patients were included in the final analysis (54 from the SSM@100 Hz cohort and 56 from the SSM@50 Hz cohort). The success rate of SSM@100 Hz was significantly higher than that of SSM@50 Hz (103/105 [98.1%] vs. 86/101 [85.1%]; p &lt; 0.001). While the combined model (SSM &gt; 50 kPa or LSM ≥ 25 kPa) and Baveno VII criteria (LSM ≥ 25 kPa) had a positive predictive value and specificity &gt; 90% to rule‐in CSPH, the combined model correctly ruled‐in more cACLD patients with CSPH compared to Baveno VII criteria alone (35/110 [31.8%] vs. 22/110 [20.0%]; p &lt; 0.001). Furthermore, the combined model (SSM &lt; 21 kPa or [LSM ≤ 15 kPa and PLT ≥ 150 × 109/L]) and Baveno VII criteria (LSM ≤ 15 kPa and PLT ≥ 150 × 109/L) had a sensitivity and negative predictive value &gt; 90% to rule‐out CSPH. Compared to the Baveno VII criteria alone, the combined model correctly ruled‐out more patients without CSPH, although there was no statistical difference (39/110 [35.5%] vs. 34/110 [30.9%]; p = 0.063). The findings remained broadly similar when subgroup analyses were performed in the SSM@100 Hz cohort and the SSM@50 Hz cohort. Notably, the combined model reduced patients in the gray zone compared to Baveno VII criteria alone (36/110 [32.7%] vs. 54/110 [49.1%]; p &lt; 0.001).ConclusionsWhether using SSM@100Hz or SSM@50Hz, the combined model of SSM and Baveno VII criteria was superior to Baveno VII criteria alone to rule‐in and rule‐out CSPH in cACLD patients, which may guide therapeutic decisions by minimizing cACLD patients in the gray zone.Trial RegistrationClinicalTrials.gov; No.NCT05251272.

Recurrence patterns and post-recurrence survival of patients with bilobar colorectal liver metastases: international multicentre retrospective study.

Recurrence patterns and post-recurrence survival of patients with bilobar colorectal liver metastases: international multicentre retrospective study.

Commentator Discussion: Single-ventricle palliation in congenitally corrected transposition of the great arteries: An international multicentre study

Commentator Discussion: Single-ventricle palliation in congenitally corrected transposition of the great arteries: An international multicentre study

Safety and efficacy of immune checkpoint therapy for the treatment of patients with cardiac metastasis: a multicenter international retrospective study

BackgroundData on the safety profiles and clinical outcomes of patients with solid tumors and cardiac metastasis treated with immune checkpoint inhibitors (ICIs) are limited.MethodsThis is an international multicenter retrospective study...

Oncological resection and perioperative outcomes of robotic, laparoscopic and open pancreatoduodenectomy for ampullary adenocarcinoma: a propensity score matched international multicenter cohort study.

Oncological resection and perioperative outcomes of robotic, laparoscopic and open pancreatoduodenectomy for ampullary adenocarcinoma: a propensity score matched international multicenter cohort study.

A multifaceted intervention to improve diagnosis and early management of hospitalised patients with suspected acute brain infections in Brazil, India, and Malawi: an international multicentre intervention study.

A multifaceted intervention to improve diagnosis and early management of hospitalised patients with suspected acute brain infections in Brazil, India, and Malawi: an international multicentre intervention study.

NEOVASCULAR GLAUCOMA AS A PREDICTOR OF RETINOBLASTOMA HIGH-RISK HISTOPATHOLOGY IN AN INTERNATIONAL MULTICENTER STUDY.

To assess histopathology and outcomes after primary enucleation of eyes with retinoblastoma presenting with neovascular glaucoma (NVG). This was an international multicenter case series study across five continents. A retrospective review of patient charts was performed for all patients undergoing primary enucleation for retinoblastoma (n = 1,420) using a standardized data-collection spreadsheet. Clinical features, pathologic grade, and outcomes were compared between NVG patients and those with an American Joint Commission on Cancer eighth edition clinical stage of cT2. High-risk histopathology was defined as American Joint Commission on Cancer eighth edition pathologic stage ≥ pT2b. Neovascular glaucoma was seen in 224/1,420 (16%) patients. The mean age at presentation of those with NVG was 30 months (median 25, range 0-120 months), and 131 (58%) patients had high-risk histopathology. The univariate logistic regression odds ratio for NVG predicting high-risk histopathology was 1.73 (95% confidence interval: 1.3-2.31) and from multivariate logistic regression was 1.77 (95% confidence interval: 1.23-2.56). Patients with a longer duration of symptoms ( P = 0.03), buphthalmos ( P = 0.02), and ectropion uveae ( P < 0.01) were more likely to have high-risk histopathology. Patients with NVG were more likely to develop metastasis than cT2 patients ( P = 0.04). There is a significant association between NVG at presentation, high-risk histopathology, and metastatic risk.

Safety of CT-guided percutaneous cryoablation in patients treated for clinical T1 renal cell carcinoma with the need for pre-procedural ureteral stenting: an international cohort study.

To assess the safety of computed tomography-guided percutaneous cryoablation (PCA) in patients who had pre-procedural ureteral stenting, while they were treated for clinical T1 renal cell carcinoma (RCC) with complex location. This retrospective international multicenter cohort study included patients treated between January 2016 and February 2021 at two University Hospitals, X1 and X2. Patients aged more than 18 years with suspected RCC were included. All patients underwent pre-procedural ureteral stenting. The complications were recorded within 30 days and graded according to the Clavien-Dindo classification and the Society of Interventional Radiology classification of adverse events. Major complications were defined as complications≥grade 3 on the Clavien-Dindo classification. The cohort included 61 patients with a median age of 66 years (IQR 55-75 years). The median tumour size was 33 mm (IQR 24-38 mm), with a median R.E.N.A.L score of 8 (IQR 7-10). A complication rate of 36% (n=22) was recorded, and major complications occurred following 10% (n=6) of the procedures. A statistically significant association was found between using more than three cryoprobes and postoperative complications (OR, 4.19; 95% CI: 1.38-12.75; p=0.010). In addition, no associations were found between postoperative complications and prophylactic antibiotics, patient age, tumour complexity, tumour size, histological type, or whether the ice ball was touching the ureter. This multicenter cohort study found a relatively high rate of postoperative complications in patients having a ureteral stent before PCA. However, no complications resulted in a chronic outflow obstruction. The number of high-complexity tumours could explain the high rate of complications.

Optimal management of hydrocephalus in children with posterior fossa tumors: an international retrospective multicenter study.

Hydrocephalus in children with posterior fossa tumors (PFTs) is commonly treated with extraventricular drain (EVD) placement, endoscopic third ventriculostomy (ETV), or tumor resection alone. However, the optimal treatment approach remains undetermined. Therefore, the objective of this study was to investigate the relationship between management of preoperative hydrocephalus in children with PFTs and the need for early postoperative CSF diversion and permanent drainage. This international multicenter retrospective cohort study included all pediatric patients (aged < 18 years) who underwent primary resection of a posterior fossa tumor at Alder Hey Children's Hospital, United Kingdom, 2008-2018; Rigshospitalet University Hospital, Denmark, 2011-2020; Aarhus University Hospital, Denmark, 2011-2020; and McMaster University Medical Centre, Canada, 2003-2020. The primary outcome was early postoperative CSF diversion (ETV, EVD, or shunt of any kind within 30 days of tumor resection). The secondary outcome was the permanent drainage (ventriculoperitoneal shunt) rate within 30 days after resection. Univariate and multivariate logistic regression analyses were performed. In total, 310 children with PFTs were included, of whom 234 (75.5%) had preoperative hydrocephalus. Preoperative hydrocephalus was successfully treated in more than 85%. Thirty-eight children (12.3%) required permanent drainage, with a higher incidence in those treated with preoperative EVD. However, no statistically significant association was found between choice of preoperative hydrocephalus management (EVD vs ETV vs tumor resection alone) and persistent hydrocephalus requiring either early postoperative CSF diversion surgery or permanent CSF drainage. This large international multicenter study did not demonstrate a significant association between choice of management of preoperative hydrocephalus (EVD, ETV, or tumor resection alone) and persisting hydrocephalus requiring surgical intervention after tumor resection.

Development of a deep learning-based system for aiding in the determination of Prostate Imaging Reporting and Data System (PI-RADS) scores: an international multicenter study

Background. Prostate multiparametric magnetic resonance imaging is widely recommended prior to biopsy in clinical practice, with the Prostate Imaging Reporting and Data System (PI-RADS) as the standard tool for guiding diagnosis and treatment decisions. However, analyzing multiparametric magnetic resonance imaging data demands substantial expertise, and the process is often time-intensive and cognitively challenging, leading to variability between and within readers.Aim. To create a deep learning-based computer-aided diagnosis (DL-CAD) system to minimize manual influence on PI-RADS score determination.Materials and methods. Between January 2020 and May 2024, 108 patients with histopathologically confirmed prostate cancer with PI-RADS scores 4–5 were retrospectively selected for model development and training. Additionally, 28 benign cases were included for model validation. Different prostate zones were labeled following PI-RADS v2.1 guidelines to facilitate model selection. Manual segmentation of prostate regions and lesions was performed on T2-weighted (T2W) sequences, and a 3D U-Net architecture was implemented for the DL model using the MONAI framework. Diagnostic performance was assessed using Python-based statistical analysis.Results. The DL-CAD system achieved average accuracy of 78 %, sensitivity of 60 %, and specificity of 84 % for lesion detection. The Dice similarity coefficient for prostate segmentation was 0.71, and the AUROC was 81.16 %.Conclusion. The DL-CAD system demonstrates promise for patients with clinically significant prostate cancer by improving diagnostic accuracy. While it exhibits high specificity, further improvements of sensitivity and segmentation accuracy are necessary. These improvements could be achieved through the use of larger datasets and advanced deep learning techniques, such as transfer learning or ensemble learning, which could enhance sensitivity without compromising specificity. Further multicenter validation is required to accelerate the integration of this system into clinical practice.

Facial Fillers and Surgical Rhinoplasty: Cross-Sectional Study.

This study aims to provide an overview of how rhinoplasty surgeons manage patients with previous nonsurgical rhinoplasty and facial fillers. A multicenter international cross-sectional study was conducted in accordance with strengthening the reporting of observational studies in epidemiology (STROBE) guidelines. A survey was distributed to members of the European Academy of Facial Plastic Surgery and associated colleagues, with responses analyzed from surgeons performing over 10 rhinoplasties annually. A total of 171 surgeons from 45 countries participated, with 165 meeting the inclusion criteria. The respondents included ear, nose, and throat (41%), plastic (7%), maxillo-facial (10%), and facial plastic surgeons (23%), averaging 116 rhinoplasties annually and 13 years of experience. Among the surgeons, 74% perform rhinoplasty on patients with prior nasal fillers, typically waiting 21 weeks after filler rhinoplasty before surgery. Additionally, 44% of surgeons remove nasal fillers preoperatively, primarily using hyaluronidase. During surgery, 76% of surgeons remove nasal fillers, and 25% modify their surgical steps for patients with a history of fillers. This study shows that there is no clear consensus in the management of patients with nasal fillers. Surgeons are often unaware of the preoperative existence of nasal and facial fillers, their potential complications, and their management. To address this, guidelines should be established to facilitate the management of the growing number of patients with facial fillers.

Bibliometric study of publications on pancreatic surgery carried out by spanish surgeons.

Bibliometric study of publications on pancreatic surgery carried out by spanish surgeons.

Open versus laparoscopic oncologic resection for gallbladder cancer after index cholecystectomy: international multicenter comparative study

BackgroundLiver resection and lymphadenectomy is a standard procedure in patients with incidental gallbladder cancer. Data regarding laparoscopic approach in this setting are scarce. The aim of this study was to compare laparoscopic and open approach in this population.MethodsThis was a multicenter retrospective study including 177 patients. The primary outcome measure was overall survival (OS). The secondary outcomes measures were recurrence-free survival (RFS), lymph node yield, operative time, postoperative complications and length of hospital stay.ResultsSurgery was laparoscopic in 60 (33.9%), including 18 conversions (30.0%). By intention to treat analysis, 3 and 5 year OS were 72.1% and 51.8% after laparoscopic surgery compared to 62.8% and 36.2% after open surgery (p = 0.201). 3- and 5-year RFS were 29.1% and 19.4% after laparoscopic surgery and 28.7% and 19.1% after open surgery (p = 0.697). Severe (grade ≥ 3 ) complications (p = 0.032) and Comprehensive Complication Index (CCI; p = 0.027) were both significantly higher after laparoscopic surgery (p = 0.032), although length of hospital stay was significantly shorter after laparoscopic procedures both on intention-to-treat (median 6 vs. 8 days; p = 0.004) and per protocol analysis (median 6 vs. 8 days; p = 0.004).ConclusionsLaparoscopic approach is feasible in patients with gallbladder cancer and may shorten the duration of hospital stay.SynopsisThis retrospective cohort study suggests that laparoscopic liver resection is feasible in patients with gallbladder cancer and may shorten the duration of hospital stay. Minimally invasive procedures should be performed by surgeons experienced in laparoscopic liver surgery.

Thrombolytic therapy with Revelisa in ischemic stroke: results of the PRIMA international multicenter observational study

Thrombolytic therapy (TLT) of ischemic stroke (IS) with alteplase within the first 4.5 hours from the onset of symptoms is the most effective and proven method of treatment.Objective: to evaluate the safety and efficacy of TLT with Revelisa (alteplase) in IS in real-world clinical practice.Material and methods. The results of TLT with Revelisa were analyzed in 1181 patients with IS: 616 (52.2%) women and 565 (47.8%) men (mean age 68.28±12.56 years), of which 140 (11.9%) with staged reperfusion. The mean time from disease onset to TLT was 2.58±0.83 hours. The Heidelberg classification was used to assess hemorrhages during neuroimaging. Symptomatic hemorrhagic transformation (HT) was defined according to ECASS III criteria. The study group was characterized by high comorbidity: arterial hypertension (96.9%), ischemic heart disease (56.7%), chronic heart failure (55.8%) and cardiac arrhythmias (33.3%) were most common; diabetes mellitus was present in 23% of patients. IS occurred repeatedly in 15.4% of cases.Results. An improvement of 4 points or more on the NIHSS scale one day after TLT was observed in 41% of patients. The dynamics of the decrease in neurological symptoms one day later and at the time of discharge were statistically significant (p&lt;0.001). The hospital mortality rate for the entire group was 8%, for the TLT group without endovascular intervention 5.6%. Twenty-nine patients (2.46%) had symptomatic HT, 14 of whom underwent endovascular intervention. The proportion of patients with a favorable clinical outcome (0–2 points on the modified Rankin scale) at discharge and at day 90 was 50.1% and 65.5%, respectively. Conclusion. The results of the PRIMA study confirm the high level of efficacy and safety of Revelisa in patients with IS, including during staged reperfusion. The data obtained are consistent with the published registry studies on alteplase in IS.&gt;&lt;0.001). The hospital mortality rate for the entire group was 8%, for the TLT group without endovascular intervention 5.6%. Twenty-nine patients (2.46%) had symptomatic HT, 14 of whom underwent endovascular intervention. The proportion of patients with a favorable clinical outcome (0–2 points on the modified Rankin scale) at discharge and at day 90 was 50.1% and 65.5%, respectively.Conclusion. The results of the PRIMA study confirm the high level of efficacy and safety of Revelisa in patients with IS, including during staged reperfusion. The data obtained are consistent with the published registry studies on alteplase in IS.

Comparative analysis of intestinal tumor segmentation in PET CT scans using organ based and whole body deep learning

Background18-Fluoro-deoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) is a valuable imaging tool widely used in the management of cancer patients. Deep learning models excel at segmenting highly metabolic tumors but face challenges in regions with complex anatomy and normal cell uptake, such as the gastro-intestinal tract. Despite these challenges, it remains important to achieve accurate segmentation of gastro-intestinal tumors.MethodsHere, we present an international multicenter comparative study between a novel organ-focused approach and a whole-body training method to evaluate the effectiveness of training data homogeneity in accurately identifying gastro-intestinal tumors. In the organ-focused method, the training data is limited to cases with intestinal tumors which makes the network trained with more homogeneous data and with stronger presence of intestinal tumor signals. The whole body approach extracts the intestinal tumors from the results of a model trained on the whole-body scans. Both approaches were trained using diffuse large B cell (DLBCL) patients from a large multi-center clinical trial (NCT01287741).ResultsWe report an improved mean(±std) Dice score of 0.78(±0.21) for the organ-based approach on the hold-out set, compared to 0.63(±0.30) for the whole-body approach, with the p-value of less than 0.0001. At the lesion level, the proposed organ-based approach also shows increased precision, recall, and F1-score. An independent trial was used to evaluate the generalizability of the proposed method to non-Hodgkin’s lymphoma (NHL) patients with follicular lymphoma (FL).ConclusionGiven the variability in structure and metabolism across tissues in the body, our quantitative findings suggest organ-focused training enhances intestinal tumor segmentation by leveraging tissue homogeneity in the training data, contrasting with the whole-body training approach, which, by its very nature, is a more heterogeneous data set.

Exploring visual search performance in preschool children with Cerebral Visual Impairment: A modified approach

Visual search difficulties are common in children with cerebral visual impairment (CVI), due to higher-order visual selective attention (VSA) deficits. However, little is known about children with CVI below 6 years. This international multi-centre study explored VSA through search performance and efficiency in preschool children aged 3–5 years with CVI ( n = 24), or a CVI-risk ( n = 20) compared with neurotypical children ( n = 47). Search performance on the paper–pencil NEPSY Visual Attention task was measured by accuracy, commission errors, and completion time. Search efficiency was assessed by reconstructing the cancellation path to obtain inter-target distances, intersections, and cluster visits. Children with CVI demonstrated significantly lower accuracy, longer completion times, greater inter-target distances, and more revisits to clusters of targets compared with both CVI-risk and neurotypical children. We conclude that by using a modified approach of a paper–pencil search task, first signs of global and local VSA deficits can be detected, offering clinical insights.

Outcomes of arteriovenous malformation patients with multiple versus single feeders: A multicenter retrospective study with propensity-score matching.

The impact of multiple feeding arteries on clinical outcomes of cerebral arteriovenous malformations (AVMs) is not well understood. This study aims to compare outcomes between AVMs with multiple versus single feeding arteries. Data from the Multicenter International Study for Treatment of Brain AVMs (MISTA) consortium were analyzed. Propensity score matching (PSM) was used to balance cohorts. Subgroup analysis was conducted for ruptured and unruptured AVMs and different treatment options, and multivariable logistic regression was applied to assess the impact of feeding artery origin. Among 953 patients, 661(69.4%) had multiple feeding arteries, and 292 (30.6%) had a single feeding artery. After PSM, which included 422 matched patients (211 in each group), the differences in obliteration rates (68.7% vs 74.8%, OR 0.73, 95% CI: 0.48-1.12, p = 0.16) and symptomatic complications (15.6% vs 11.8%, OR 1.37, 95% CI: 0.78-2.41, p = 0.25) were not significant. Subgroup analysis comparing ruptured and unruptured AVMs and different treatment options showed no significant differences across all subgroups. Multivariable analysis identified PICA feeders as significantly associated with increased odds of all complications (OR 7.33, 95% CI: 2.14-25.1, p = 0.002). AVMs with a single feeding artery were more likely to present with rupture, but no significant differences in obliteration rates or complications were observed between the groups after PSM. These findings suggest that while the number of feeding arteries may influence the initial presentation, it does not appear to impact overall treatment success or patient prognosis. Further prospective studies are needed to confirm these findings.