Comparison Between Different Techniques in Difficult CBD Cannulation

Not Applicable

Completed

• Conditions: ERCP, Difficult CBD Cannulation
• Interventions: Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation

• Registration Number: NCT06315647
• Lead Sponsor: Menoufia University

Brief Summary

This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation.

Detailed Description

Endoscopic retrograde cholangiopancreatography (ERCP) is the standard procedure for diagnostic and therapeutic interventions for pancreatobiliary diseases. Bile duct cannulation is the most basic and important technique for carrying out diagnostic and therapeutic biliary interventions.

Since the advent of ERCP selective cannulation of the biliary duct is the most important step for successful treatment of biliary tract diseases during ERCP procedures, despite various accessory devices, the standard biliary cannulation technique has been reported to fail in approximately 5-20% cases.

Various endoscopic techniques for Selective Bile duct cannulation have been reported, including standard techniques (e.g. contrast injection technique, wire-guided cannulation ), pancreatic guidewire technique (e.g. double guidewire technique \[DGW\]), precut sphincterotomy, endoscopic papillectomy, endoscopic ultrasound-guided rendezvous procedure, and percutaneous transhepatic biliary drainage-guided procedure.

Bile duct cannulation can be difficult because of; different anatomical features, inflammatory processes, and adenomas of the papilla or periampullary diverticulum. Large prospective studies have demonstrated that difficult cannulation is an independent risk factor for post ERCP pancreatitis.

As the technique developed, several supplementary techniques have been recommended to facilitate the access to the common bile duct in cases of standard biliary cannulation failure, these are known to significantly increase not only the success rate of selective biliary cannulation but also the complication rate .

Commonly, a precutting technique is used to allow biliary access when the standard cannulation technique failed. There are types of precutting technique: needle-knife papillotomy, suprapapillary fistulotomy and trans pancreatic sphincterotomy, in terms of effectiveness and efficiency of the precutting technique, TPS, which does not need avoiding pancreatic duct cannulation unintentionally, is an effective method especially for difficult biliary cannulation.

Also, the use of a guidewire to physically occupy the pancreatic duct, also known as the double guidewire technique, this method has been used with promising results in cases of complex biliary cannulation, especially in patients with a distorted BD anatomy caused by neoplasia or atypical morphology of the ampulla.

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2023-01-19
• Study Completion: 2023-11-20
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients having different biliary tract disorders for which ERCP is indicated and after which they defined as having difficult CBD cannulation.

Exclusion Criteria

1. Age of less than18 years.
2. Coagulopathy in terms of INR>2.
3. Patients with severe heart disease defined as patients with decompensated heart diseases or EF > 40%.
4. Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
5. Complicated acute pancreatitis defined as patients with moderate to sever acute pancreatitis according to Revised ATLANTA criteria 2012.
6. Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients enrolled for double guide wire technique.	DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation	-
Patients enrolled for trans - pancreatic sphincterotomy technique.	DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation	-
Patients enrolled for needle knife precut technique or fistulotomy technique.	DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation	-

Primary Outcome Measures

Name	Time	Method
Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography	Baseline	compare efficacy of different cannulation techniques for difficult CBD cannulation

Trial Locations

Locations (1)

National liver Institute; 🇪🇬 Shibīn Al Kawm, Menofia, Egypt