Background: Combined Immuno‐chemotherapy consisting of gemcitabine, cisplatin and the programmed death‐ligand one inhibitor durvalumab (GCD) is the new standard of care for patients with biliary tract cancers (BTC) based on positive results of the TOPAZ‐1 study.Objective: We here evaluated the efficacy and safety of GCD for BTC in a German multicenter real‐world patient cohort.Methods: Patients with BTC treated with GCD from 9 German centers were included. Clinicopathological baseline parameters, overall survival (OS), response rate and adverse events (AEs) were retrospectively analyzed. The prognostic impact was determined by Kaplan–Meier analyses and Cox regression models.Results: A total of 165 patients treated with GCD between 2021 and 2024 were included in the study. Median OS and median progression‐free survival were 14 months (95% CI 10.3–17.7) and 8 months (95% CI 6.8–9.2), respectively. The best overall response rate was 28.5% and disease control rate was 65.5%. While extrahepatic and intrahepatic BTC showed similar outcomes, mOS was significantly shorter in patients with gall bladder cancer (GB‐CA) with 9 months (95% CI 5.5–12.4; p = 0.02). In univariate analyses age ≥70 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥1, status post cholecystectomy, GB‐CA and high baseline CRP values were significantly associated with OS. ECOG PS ≥ 1 and GB‐CA remained independent prognostic factors for OS in multivariable cox regression analysis. AEs have been reported in 130 patients (78.8%), including 149 grade 3–4 AEs (25.5%). One patient died of severe infectious pneumonia. Immune‐related (ir)AEs occurred in 17 patients (10.3%), including 9 grade 3–4 irAEs (2.2%), which led to treatment interruption in 4 patients.Conclusions: Immuno‐chemotherapy in patients with BTC was feasible, effective and safe in a real‐life scenario. Our results were comparable to the phase 3 clinical trial results (TOPAZ‐1). Reduced efficacy was noted in patients with GB‐CA and/or a reduced performance status that warrants further investigation.

Biliary tract cancers (BTC) are rare but aggressive. Due to limited anti‑tumor effects of current second‑ and later‑line treatment regimens, novel treatment options are required. Nanoliposomal irinotecan in combination with leucovorin and 5‑fluorouracil (FOLFnal‑IRI) achieved promising results as a second‑line treatment in patients with pancreatic cancer, warranting further investigation in BTC. In the present study, a retrospective analysis of patients receiving FOLFnal‑IRI after initial platinum‑based chemotherapy for advanced BTC between January 2016 and August 2020 at the University Hospital Cologne (Cologne, Germany) was performed. A total of 11 patients were identified who met the inclusion criteria. A total of 4 patients (36.4%) were female and the median age was 54 years. The proportion of patients suffering from gallbladder carcinoma, intrahepatic and extrahepatic cholangiocarcinoma was 18.2, 63.6 and 9.1%, respectively. Furthermore, 7 patients (63.6%) received FOLFnal‑IRI as their second‑, 3 (27.3%) as third‑ and one (9.1%) as their fourth‑line therapy. The disease control rate was 54.5% and 3 grade III toxicities were recorded. Progression‑free survival and overall survival (OS) after initiation of FOLFnal‑IRI was 5.1 and 12.4 months, respectively. OS after initial diagnosis was 24.7 months. FOLFnal‑IRI demonstrated promising antitumor potential with an acceptable safety profile as a subsequent therapy regimen in advanced biliary tract malignancies. Further randomized controlled trials of its value as a treatment option for BTC appear justified.

Objectives The management of upper gastrointestinal bleeding (UGIB) has seen rapid advancements with revolutionising innovations. However, insufficient data exist on the necessary number of emergency endoscopies needed to achieve competency in haemostatic interventions. Design We retrospectively analysed all oesophagogastroduodenoscopies with signs of recent haemorrhage performed between 2015 and 2022 at our university hospital. A learning curve was created by plotting the number of previously performed oesophagogastroduodenoscopies with signs of recent haemorrhage against the treatment failure rate, defined as failed haemostasis, rebleeding and necessary surgical or radiological intervention. Results The study population included 787 cases with a median age of 66 years. Active bleeding was detected in 576 cases (73.2%). Treatment failure occurred in 225 (28.6%) cases. The learning curve showed a marked decline in treatment failure rates after nine oesophagogastroduodenoscopies had been performed by the respective endoscopists followed by a first plateau between 20 and 50 procedures. A second decline was observed after 51 emergency procedures followed by a second plateau. Endoscopists with experience of 51 emergency oesophagogastroduodenoscopies performed (p=0.039) or consultants (p=0.041). Conclusions Our data suggest that a minimum number of 20 oesophagogastroduodenoscopies with signs of recent haemorrhage is necessary before endoscopists should be considered proficient to perform emergency procedures independently. Endoscopists might be considered as advanced-qualified experts in managing UGIB after a minimum of 50 haemostatic procedure performed. Implementing recommendations on minimum numbers of emergency endoscopies in education programmes of endoscopy trainees could improve their confidence and competency in managing acute UGIB.

Upper gastrointestinal bleeding (UGIB) from malignancies is associated with a poor outcome. Only a small number of studies on gastrointestinal tumor bleeding have been published so far, focusing ma...

Introduction: Use of risk scores for early assessment of patients with upper gastrointestinal bleeding (UGIB) is recommended by various guidelines. We compared Cologne-WATCH (C-WATCH) score with Glasgow-Blatchford score (GBS), Rockall score (RS), and pre-endoscopic RS (p-RS). Methods: Patients with UGIB between January and December 2017 were retrospectively analyzed for 30-day mortality and composite endpoints risk of complications and need for intervention using areas under the receiver-operating characteristics curve (AUROC). Subgroup analysis was conducted for patients with UGIB on admission and in-hospital UGIB. Results: A total of 252 patients were identified (67.5% men, mean age 63.8 ± 14.9 years). In-hospital UGIB occurred in 49.6%. AUROCs for 30-day mortality, risk of complications, and need for intervention (not applicable to RS) were 0.684 (95% confidence interval [CI]: 0.606–0.763), 0.665 (95% CI: 0.594–0.735), and 0.694 (95% CI: 0.612–0.775) for C-WATCH score, 0.724 (95% CI: 0.653–0.796) and 0.751 (95% CI: 0.687–0.815) for RS, 0.652 (95% CI: 0.57–0.735), 0.653 (95% CI: 0.579–0.727), and 0.673 (95% CI: 0.602–0.745) for p-RS and 0.652 (95% CI: 0.572–0.732), 0.663 (95% CI: 0.592–0.734), and 0.752 (95% CI: 0.683–0.821) for GBS. RS outperformed pre-endoscopic scores in predicting risk of complications, while there were no significant differences between pre-endoscopic scores except GBS outperforming p-RS in predicting need for intervention. The subgroup analysis obtained similar results. Positive predictive values for patients with estimated low risk for all three endpoints (C-WATCH score ≤1, RS ≤2, p-RS <1, and GBS ≤1) were 89%, 69%, 78%, and 92%. Conclusion: C-WATCH score performed similar to the established pre-endoscopic risk scores in patients with UGIB regarding relevant patient-related endpoints with no significant differences between both the subgroups.

BackgroundThe goal of the present study was to develop a convolutional neural network for the detection of bleedings in capsule endoscopy videos using realistic clinical data from one single-centre.MethodsCapsule endoscopy videos from all 133 patients (79 male, 54 female; meanage = 53.73 years, SDage = 26.13) who underwent capsule endoscopy at our institution between January 2014 and August 2018 were screened for pathology. All videos were screened for pathology by two independent capsule experts and confirmed findings were checked again by a third capsule expert. From these videos, 125 pathological findings (individual episodes of bleeding spanning a total of 5696 images) and 103 non-pathological findings (sections of normal mucosal tissue without pathologies spanning a total of 7420 images) were used to develop and validate a neural network (Inception V3) using transfer learning.ResultsThe overall accuracy of the model for the detection of bleedings was 90.6% [95%CI: 89.4%-91.7%], with a sensitivity of 89.4% [95%CI: 87.6%-91.2%] and a specificity of 91.7% [95%CI: 90.1%-93.2%].ConclusionOur results show that neural networks can detect bleedings in capsule endoscopy videos under realistic, clinical conditions with an accuracy of 90.6%, potentially reducing reading time per capsule and helping to improve diagnostic accuracy.