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

Primary Purpose

Bile Duct Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Angled guidewire
Straight guidewire
Sponsored by
Lahey Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bile Duct Diseases focused on measuring ERCP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lahey Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Angled wire

Straight wire

Arm Description

Angled guidewire intervention arm

Straight guidewire intervention arm

Outcomes

Primary Outcome Measures

Cannulation
Rate of successful cannulation of common bile duct

Secondary Outcome Measures

post ERCP pancreatitis
Number of participants who develop post ERCP pancreatitis
Duration
Total duration of procedure

Full Information

First Posted
October 26, 2022
Last Updated
October 2, 2023
Sponsor
Lahey Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05600270
Brief Title
Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation
Official Title
Comparison Between an Angled-tip and Straight-tip Guidewire in Biliary Cannulation: a Prospective, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2022 (Actual)
Primary Completion Date
August 24, 2023 (Actual)
Study Completion Date
August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lahey Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Diseases
Keywords
ERCP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Controlled, Single-Blinded Trial
Masking
Participant
Masking Description
Single-blinded study with masking of participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angled wire
Arm Type
Active Comparator
Arm Description
Angled guidewire intervention arm
Arm Title
Straight wire
Arm Type
Active Comparator
Arm Description
Straight guidewire intervention arm
Intervention Type
Device
Intervention Name(s)
Angled guidewire
Intervention Description
Cannulation of the common bile duct using an angled-tip guidewire during ERCP
Intervention Type
Device
Intervention Name(s)
Straight guidewire
Intervention Description
Cannulation of the common bile duct using an straight-tip guidewire during ERCP
Primary Outcome Measure Information:
Title
Cannulation
Description
Rate of successful cannulation of common bile duct
Time Frame
Day of Procedure
Secondary Outcome Measure Information:
Title
post ERCP pancreatitis
Description
Number of participants who develop post ERCP pancreatitis
Time Frame
Procedure day and up to day 5 post procedure
Title
Duration
Description
Total duration of procedure
Time Frame
Day of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Marie Joyce, MD
Organizational Affiliation
Lahey Hospital & Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23250671
Citation
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.
Results Reference
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Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation

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