Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation

Not Applicable

Completed

• Conditions: Bile Duct Diseases
• Interventions: Device: Straight guidewire; Device: Angled guidewire

• Registration Number: NCT05600270
• Lead Sponsor: Neev Mehta

Brief Summary

The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. The primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.

Detailed Description

Wire-guided cannulation of the common bile duct is a standard technique utilized during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to ensure safe and effective access to the common bile duct via the ampulla of Vater. Due to the anatomy of the ampulla, and the orientation of the biliary orifice, a guidewire with an angled tip may allow easier and safer access to the common bile duct without inadvertent manipulation of the pancreatic duct. The investigators aim to assess the technical and clinical outcomes between an angled-tip guidewire (GW) compared to a straight-tip guidewire in wire-guided cannulation of the common bile duct. The investigators hypothesize that an angled-tip GW is associated with increased rate of successful cannulation, decreased procedure time and decreased rate of post-ERCP pancreatitis in wire-guided biliary cannulation during ERCP.

Study Timeline

• Study Start: 2022-10-22
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Primary Completion: 2023-08-24
• Study Completion: 2023-08-24
• Status Verified: 2024-10
• Results First Submitted: 2024-10-09
• Results First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Results First Posted: 2024-10-31
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients undergoing ERCP for cholangiography, bile or tissue sampling from the gallbladder or bile duct
• patients undergoing ERCP for treatment of biliary diseases (removal of common bile duct stones, biliary stent placement)

Exclusion Criteria

• Patients who are less than 18 years old
• Pregnant patients
• Patients who have undergone previous bile duct cannulation or sphincterotomy
• Patients who have undergone prior endoscopic balloon dilation or needle-knife fistulotomy
• Patients who have undergone gastric surgery (Billroth gastrectomy II, Roux-en-Y gastric bypass)
• Patients with acute pancreatitis
• Patients who refuse endoscopic intervention
• Patients with ampullary tumor, duodenal stenosis, or pre-operatively proven pancreaticobiliary malunion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Straight wire	Straight guidewire	Straight guidewire intervention arm
Angled wire	Angled guidewire	Angled guidewire intervention arm

Primary Outcome Measures

Name	Time	Method
Cannulation	Day of Procedure	Rate of successful cannulation of common bile duct

Secondary Outcome Measures

Name	Time	Method
Post ERCP Pancreatitis	Procedure day and up to day 5 post procedure	Number of participants who develop post ERCP pancreatitis
Duration	Day of procedure	Total duration of procedure

Trial Locations

Locations (1)

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States