Efficacy of Fistulotomy for Biliary Cannulation

Launched by COORDINACIÓN DE INVESTIGACIÓN EN SALUD, MEXICO · Jul 26, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a technique called fistulotomy to improve access to the bile duct for patients with certain bile duct conditions, like gallstones or tumors. The goal is to see if this method, compared to the standard guidewire technique, can increase the success rate of a procedure called ERCP, which helps doctors diagnose and treat problems in the bile ducts. The trial will involve experienced and less experienced doctors to see if their skill levels affect the outcomes.

To participate in this study, you need to be between 65 and 87 years old and have a condition affecting your bile ducts, such as gallstones or strictures (narrowing) caused by tumors or other issues. Unfortunately, if you have had previous surgeries that changed your digestive system or certain cancers, you won’t be eligible. If you join the trial, you can expect to receive one of the two techniques being studied during your ERCP procedure, and your progress will be monitored to see which method works best. This research is important because it could lead to better treatment options for people with bile duct problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis.
• Exclusion Criteria:
• • patients with previous ERCP, altered gastro-duodenal anatomy by previous surgery, suspicion or diagnosis of ampullary neoplasm, duodenal cancer, periampullary diverticula types 1 and 2, pregnant women, coagulopathy with INR greater than 1.5.
• Elimination Criteria:
• • - Incomplete procedure due to anesthesia adverse events.