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NCT05600270

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

Completed NA Results posted Last updated 31 October 2024
What this trial tests

NA trial testing Angled guidewire in Bile Duct Diseases in 70 participants. Completed in 24 August 2023.

Timeline
22 October 2022
Primary endpoint
24 August 2023
24 August 2023

Quick facts

Lead sponsorNeev Mehta
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment70
Start date22 October 2022
Primary completion24 August 2023
Estimated completion24 August 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Neev Mehta

Who can join

18 and older, any sex, with Bile Duct Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cannulation Primary · Day of Procedure

Rate of successful cannulation of common bile duct

GroupValue95% CI
Angled Wire30
Straight Wire31
Post ERCP Pancreatitis Secondary · Procedure day and up to day 5 post procedure

Number of participants who develop post ERCP pancreatitis

GroupValue95% CI
Angled Wire1
Straight Wire2
Duration Secondary · Day of procedure

Total duration of procedure

GroupValue95% CI
Angled Wire1964.26557 – 8520
Straight Wire1569.03711 – 4368

Adverse events — posted to ClinicalTrials.gov

Time frame: Randomization on day of procedure to post procedure day 5. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Angled Wire
Serious: 1/33 (3%)
Deaths: 0/33
Straight Wire
Serious: 2/33 (6%)
Deaths: 0/33

Serious adverse events (4 terms)

ReactionSystemAngled WireStraight Wire
post ERCP PancreatitisGastrointestinal disorders
PerforationGastrointestinal disorders
BleedingGastrointestinal disorders
Post ERCP CholangitisInfections and infestations

Most-reported serious reactions: post ERCP Pancreatitis, Perforation, Bleeding, Post ERCP Cholangitis.

Data from ClinicalTrials.gov NCT05600270 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Bile Duct Diseases

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05600270.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing