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

Neev Mehta

Status: Completed

Conditions: Bile Duct Diseases

Treatments: Device: Straight guidewire; Device: Angled guidewire

Study type: Interventional

Funder types: Other

Identifiers

NCT05600270

20223146

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Angled wire

Active Comparator group

Description:

Angled guidewire intervention arm

Treatment:

Device: Angled guidewire

Straight wire

Active Comparator group

Description:

Straight guidewire intervention arm

Treatment:

Device: Straight guidewire