Clinical trial NCT06315647: Comparison Between Different Techniques in Difficult CBD Cannulation
Official title: Comparative Study Between Double Guide Wire Technique Versus Trans Pancreatic Sphincterotomy Versus Precut and Fistulotomy Techniques for Difficult Biliary Cannulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ERCP, Difficult CBD Cannulation
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: National liver Institute
state: Menofia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.