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NCT05600270 Clinical Trial

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

Bile Duct Diseases Clinical Trial

Official title:
Comparison Between an Angled-tip and Straight-tip Guidewire in Biliary Cannulation: a Prospective, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05600270
Other study ID # 20223146
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2022
Est. completion date August 24, 2023

Study information
Verified date October 2023
Source Lahey Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date August 24, 2023
Est. primary completion date August 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Angled guidewire
Cannulation of the common bile duct using an angled-tip guidewire during ERCP
• Straight guidewire
Cannulation of the common bile duct using an straight-tip guidewire during ERCP

Locations
Country Name City State
United States Lahey Hospital and Medical Center Burlington Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vihervaara H, Gronroos JM, Koivisto M, Gullichsen R, Salminen P. Angled- or straight-tipped hydrophilic guidewire in biliary cannulation: a prospective, randomized, controlled trial. Surg Endosc. 2013 Apr;27(4):1281-6. doi: 10.1007/s00464-012-2596-6. Epub 2012 Dec 19. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cannulation Rate of successful cannulation of common bile duct Day of Procedure
Secondary post ERCP pancreatitis Number of participants who develop post ERCP pancreatitis Procedure day and up to day 5 post procedure
Secondary Duration Total duration of procedure Day of procedure
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