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OpenTrials
Completed

NCT Number: NCT05600270

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angled guidewire

Device

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

Straight guidewire

Device

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

Primary outcomes

  1. Cannulation

    Time frame: Day of Procedure

    Rate of successful cannulation of common bile duct

Secondary outcomes

  1. Post ERCP Pancreatitis

    Time frame: Procedure day and up to day 5 post procedure

    Number of participants who develop post ERCP pancreatitis

  2. Duration

    Time frame: Day of procedure

    Total duration of procedure

Sponsors and collaborators

Lead sponsor

Neev Mehta

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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