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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-22

Study Completion Date

2023-08-24

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bile Duct Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Controlled, Single-Blinded Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single-blinded study with masking of participant

Study Groups

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Angled wire

Angled guidewire intervention arm

Group Type ACTIVE_COMPARATOR

Angled guidewire

Intervention Type DEVICE

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

Straight wire

Straight guidewire intervention arm

Group Type ACTIVE_COMPARATOR

Straight guidewire

Intervention Type DEVICE

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

Interventions

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Angled guidewire

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

Intervention Type DEVICE

Straight guidewire

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes