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

October 9, 2024 updated by: Neev Mehta

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Angled wire
Angled guidewire intervention arm
Device: Angled guidewire
Cannulation of the common bile duct using an angled-tip guidewire during ERCP
Active Comparator: Straight wire
Straight guidewire intervention arm
Device: Straight guidewire
Cannulation of the common bile duct using an straight-tip guidewire during ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannulation
Time Frame: Day of Procedure
Rate of successful cannulation of common bile duct
Day of Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration
Time Frame: Day of procedure
Total duration of procedure
Day of procedure
Post ERCP Pancreatitis
Time Frame: Procedure day and up to day 5 post procedure
Number of participants who develop post ERCP pancreatitis
Procedure day and up to day 5 post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neev Mehta

Investigators

  • Principal Investigator: Ann Marie Joyce, MD, Lahey Hospital & Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2022

Primary Completion (Actual)

August 24, 2023

Study Completion (Actual)

August 24, 2023

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20223146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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