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

Sponsor

Lahey Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05600270

Collaborator

(none)

250

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

20.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our 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. Our 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.

Condition or Disease	Intervention/Treatment	Phase
Bile Duct Diseases	Device: Angled guidewire Device: Straight guidewire	N/A

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. We 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. We 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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, Controlled, Single-Blinded TrialRandomized, Controlled, Single-Blinded Trial

Masking:

Single (Participant)

Masking Description:

Single-blinded study with masking of participant

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 22, 2022

Anticipated Primary Completion Date :

Oct 25, 2023

Anticipated Study Completion Date :

Oct 25, 2023

Arms and Interventions

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 straigh-tip guidewire during ERCP

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 straigh-tip guidewire during ERCP

Outcome Measures

Primary Outcome Measures

Cannulation [Day of Procedure]
successful cannulation of common bile duct

Secondary Outcome Measures

post ERCP pancreatitis [Procedure day and up to day 5 post procedure]
Incidence of post ERCP pancreatitis
Duration [Day of procedure]
Total duration of procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients undergoing ERCP for cholangiography, bile or tissue sampling from the gallbladder or bile duct, or 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lahey Hospital and Medical Center	Burlington	Massachusetts	United States	01805

Sponsors and Collaborators

Lahey Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Ann Marie Joyce, Director of Advanced Endoscopy, Lahey Clinic

ClinicalTrials.gov Identifier:

NCT05600270

Other Study ID Numbers:

20223146

First Posted:

Oct 31, 2022

Last Update Posted:

Oct 31, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Ann Marie Joyce, Director of Advanced Endoscopy, Lahey Clinic

ERCP

Additional relevant MeSH terms:

Bile Duct Diseases

Study Results

No Results Posted as of Oct 31, 2022