Bile Duct Diseases Clinical Trial
Official title:
Comparison Between an Angled-tip and Straight-tip Guidewire in Biliary Cannulation: a Prospective, Randomized Trial
Verified date | October 2023 |
Source | Lahey Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | August 24, 2023 |
Est. primary completion date | August 24, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Lahey Hospital and Medical Center | Burlington | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Lahey Clinic |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cannulation | Rate of successful cannulation of common bile duct | Day of Procedure | |
Secondary | post ERCP pancreatitis | Number of participants who develop post ERCP pancreatitis | Procedure day and up to day 5 post procedure | |
Secondary | Duration | Total duration of procedure | Day of procedure |
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