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Bile Leak clinical trials

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NCT ID: NCT05141942 Recruiting - Bile Leak Clinical Trials

The Need for Repeat ERCP After Endoscopic Treatment of Postsurgical Biliary Leaks

Start date: November 19, 2019
Phase:
Study type: Observational [Patient Registry]

Post-surgical biliary leaks are relatively common after surgeries associated with hepatobiliary health. Left untreated, biliary leaks can lead to significant morbidity. Biliary leaks are most often successfully managed endoscopically, by way of performing an ERCP (endoscopic retrograde cholangio-pancreatography) procedure. These procedures help manage the bile leak by decreasing pressure at the opening of the common bile duct and promoting bile flow into the small bowel (rather than out the leak) via stent insertion. Guidelines published by the American Society for Gastrointestinal Endoscopy (ASGE) report that stents are generally placed for 4 to 6 weeks and recommend longer intervals for more complex leaks. However, formal recommendations concerning the modality of biliary stent removal do not exist. One option is performing a repeat ERCP when removing the stent. While comprehensive, this exposes the patient to additional radiation, and requires additional fluoroscopy resources and/or technicians. Furthermore, ERCPs are less available, especially in smaller centers, and are costly. A second option is a gastroscopy with simple stent removal has, given the low probability of requiring repeat intervention, the relatively low procedural cost, and the relatively favorable adverse event profile, and easier accessibility compared to ERCP procedures. A simple, safe and reliable prediction rule was developed retrospectively to identify patients in whom biliary stent removal via gastroscopy could be safely performed, as opposed to repeat ERCP. A positive result using the rule requires satisfaction of four non-invasive clinical markers: (1) a normal post-surgical serum alkaline phosphatase value, (2) bile leak 'type C' at initial ERCP (a small or absent leak with no other biliary pathology), (3) a bile leak caused by laparoscopic cholecystectomy, and (4) a time between initial and follow-up endoscopy of 4 to 8 weeks. Validating this prediction rule prospectively could have implications on patient safety by decreasing ERCP-related adverse events, and could also have important implications with regard to health resource utilization.

NCT ID: NCT04665427 Recruiting - Bile Leak Clinical Trials

Bile Leaks After Biliary Surgery

Start date: November 18, 2020
Phase: N/A
Study type: Interventional

The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.

NCT ID: NCT03753880 Recruiting - Bile Leak Clinical Trials

Hemopatch for Prevention of Bile Leaks After Liver Resection

Start date: October 23, 2019
Phase: N/A
Study type: Interventional

In liver surgery bile leaks are still a major cause of postoperative morbidity with the need for additional diagnostic tests, additional interventions, prolonged hospital stay, mortality and higher costs. Efforts to further reduce the rate of postoperative biliary morbidity are therefore important.A new polyethylene glycol (PEG)-coated collagen pad (Hemopatch®) showed faster and more sustained hemostasis, less blood loss, and lower hematoma formation than the fibrin-coated collagen patch in an animal model. This might be attributed to an improved tissue adherence of the PEG-coated pad. We hypothesize that this strong adherence to the hepatic resection surface may also serve as a mechanical sealant of bile ducts thus preventing biliary leakage. To date, there exists no study including a sufficient number of patients to clarify whether sealing of the hepatic resection surface with Hemopatch® can reduce the rate of biliary leaks and data regarding the expected difference in the incidence of biliary complications are lacking.

NCT ID: NCT02545153 Recruiting - Infection Clinical Trials

Fibrin Sealant for Cholangiotomy Closure Study

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.

NCT ID: NCT01438385 Recruiting - Colorectal Cancer Clinical Trials

Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

Start date: July 2011
Phase: N/A
Study type: Observational

Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ), Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year. Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders. The investigators would like to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients.