Comparison Between Different Techniques in Difficult CBD Cannulation

Comparative Study Between Double Guide Wire Technique Versus Trans Pancreatic Sphincterotomy Versus Precut and Fistulotomy Techniques for Difficult Biliary Cannulation

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.

Study Overview

• Status: Completed
• Conditions: ERCP, Difficult CBD Cannulation
• Intervention / Treatment: Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD 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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menofia
    • Shibīn Al Kawm, Menofia, Egypt, 32951
      • National Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients enrolled for double guide wire technique.	Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation; comparison between different technique in difficult CBD cannulation
Active Comparator: Patients enrolled for trans - pancreatic sphincterotomy technique.	Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation; comparison between different technique in difficult CBD cannulation
Active Comparator: Patients enrolled for needle knife precut technique or fistulotomy technique.	Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation; comparison between different technique in difficult CBD cannulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Menoufia University

Publications and helpful links

General Publications

• Miao L, Li QP, Zhu MH, Ge XX, Yu H, Wang F, Ji GZ. Endoscopic transpancreatic septotomy as a precutting technique for difficult bile duct cannulation. World J Gastroenterol. 2015 Apr 7;21(13):3978-82. doi: 10.3748/wjg.v21.i13.3978.
• Yoo YW, Cha SW, Lee WC, Kim SH, Kim A, Cho YD. Double guidewire technique vs transpancreatic precut sphincterotomy in difficult biliary cannulation. World J Gastroenterol. 2013 Jan 7;19(1):108-14. doi: 10.3748/wjg.v19.i1.108.
• Huang L, Yu QS, Zhang Q, Liu JD, Wang Z. Comparison between double-guidewire technique and transpancreatic sphincterotomy technique for difficult biliary cannulation. Dig Endosc. 2015 Mar;27(3):381-7. doi: 10.1111/den.12387. Epub 2014 Nov 11.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Difficult CBD cannulation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No