N/A
N=66
Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation
Bile Duct Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05600270 ↗Enrolled (actual)
66
Serious AEs
4.6%
Results posted
Oct 2024
Primary outcome: Primary: Cannulation — 30; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Angled guidewire (Device); Straight guidewire (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neev Mehta
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cannulation |
30; 31 | — |
| SECONDARY Post ERCP Pancreatitis |
1; 2 | — |
| SECONDARY Duration |
1964.26; 1569.03 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05600270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.