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

NCT05600270 | Completed Results DMC FDA Device

• 1 other identifier: 20223146
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Duct Diseases

Keywords

ERCP

Outcome Measures

Primary Outcomes (1)

• Cannulation

  Rate of successful cannulation of common bile duct

  Day of Procedure

Secondary Outcomes (2)

• Post ERCP Pancreatitis

  Procedure day and up to day 5 post procedure

• Duration

  Day of procedure

Study Arms (2)

Angled wire

ACTIVE COMPARATOR

Angled guidewire intervention arm

Device: Angled guidewire

Straight wire

ACTIVE COMPARATOR

Straight guidewire intervention arm

Device: Straight guidewire

Interventions

Angled guidewire DEVICE

Cannulation of the common bile duct using an angled-tip guidewire during ERCP

Angled wire

Straight guidewire DEVICE

Cannulation of the common bile duct using an straight-tip guidewire during ERCP

Straight wire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Neev Mehta: lead

Study Sites (1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Related 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.

  PMID: 23250671 BACKGROUND

MeSH Terms

Conditions

Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Results Point of Contact

• Title: Neev Mehta
• Organization: Lahey Hospital and Medical Center

neev.n.mehta@lahey.org

781-744-1933

Study Officials

• Ann Marie Joyce, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded study with masking of participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Coordinator

Model Details: Randomized, Controlled, Single-Blinded Trial

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: October 22, 2022
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)