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

Study Overview
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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.

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.

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

Conditions
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Bile Duct Diseases

Intervention / Treatment
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* Device: Angled guidewire
* Device: Straight guidewire


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Controlled, Single-Blinded Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angled wire<br>Angled guidewire intervention arm | Device: Angled guidewire<br>* Cannulation of the common bile duct using an angled-tip guidewire during ERCP<br>|
| Active Comparator: Straight wire<br>Straight guidewire intervention arm | Device: Straight guidewire<br>* Cannulation of the common bile duct using an straight-tip guidewire during ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannulation | Rate of successful cannulation of common bile duct | Day of Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post ERCP pancreatitis | Number of participants who develop post ERCP pancreatitis | Procedure day and up to day 5 post procedure | 
| Duration | Total duration of procedure | Day of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP