Comparison Between Different Techniques in Difficult CBD Cannulation

Menoufia University

Status: Completed

Conditions: ERCP, Difficult CBD Cannulation

Treatments: Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06315647

Difficult CBD cannulation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 3 patient groups

Patients enrolled for double guide wire technique.

Active Comparator group

Treatment:

Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation

Patients enrolled for trans - pancreatic sphincterotomy technique.

Active Comparator group

Treatment:

Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation

Patients enrolled for needle knife precut technique or fistulotomy technique.

Active Comparator group

Treatment:

Procedure: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation