Clinical trial NCT05600270: Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation
Official title: Comparison Between an Angled-tip and Straight-tip Guidewire in Biliary Cannulation: a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bile Duct Diseases
Keywords: ERCP
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Controlled, Single-Blinded Trial
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cannulation
timeFrame: Day of Procedure
Secondary outcomes:
measure: Post ERCP Pancreatitis
timeFrame: Procedure day and up to day 5 post procedure
measure: Duration
timeFrame: Day of procedure
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Hospital & Medical Center
name: Ann Marie Joyce, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.