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NCT02197338 · ClinicalTrials.gov registry record · NA

Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation

A NA study, sponsored by University of Southern California.

Completed
Registry status
NA
Development phase
498
Enrollment target

NCT02197338: Completed NA study, sponsored by University of Southern California.

NCT02197338 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 498 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02197338, a NA study, has completed, sponsored by University of Southern California.

COMPLETED
Registry status
NA
Development phase
498 participants
Enrollment target

Study Summary

1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer. 2. Given the small size of the bile duct orifice and its close proximity to the pancreatic duct, selective biliary cannulation is the most difficult part of the endoscopic retrograde cholangiography (ERCP). 3. New small diameter sphincteromes and "short wire" systems (which allow physicians to control guidewires) offer potential, though untested advantages. 4. At most hosptial both the long and short wire systems as well as small versus standard are routinely used for clinical care. 5. Our hypothesis is that small diameter, physician controlled wires favor biliary cannulation 6. Our objective will be to assess whether small diameter sphincterotomes and "short wire" physician controlled guidewire cannulation favors successful bile duct cannulation and minimize complications.

Primary Outcome

The primary outcome is successful initial cannulation as defined by bile duct with the assigned technology (ie size of cannulatome and type of wire system) within the first 8 attempts. The rates of cannulation among the 4 groups will be compared.

Interventions

  • OTHER Bile Duct Cannulation

Trial Details

FieldValue
Enrollment Target 498 participants
Start Date 2016-04
Est. Completion 2016-04
Phase NA
University of Southern California

617 total trials

What the finished NCT02197338 record still lists

NCT02197338 is an interventional study that assigns participants to a tested intervention. The registered 498 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 1 intervention - of which Bile Duct Cannulation is the first listed.

NCT02197338 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02197338 about?

NCT02197338 is a clinical study titled "Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation". 1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer. 2. Given the small size of the bile duct orifice and its close proximity to the pancreatic duct, selective biliary cannula...

What is the current status of trial NCT02197338?

This trial is currently completed. It is a NA study. The enrollment target is 498 participants. The study started on 2016-04. Estimated completion is 2016-04.

What interventions are being tested in trial NCT02197338?

The interventions under investigation include: Bile Duct Cannulation (OTHER).

Who is sponsoring clinical trial NCT02197338?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02197338's enrollment target sits among peer trials

498 213th of 2000 higher than 1,788 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02197338, the US trial registry maintained by the National Library of Medicine. NCT02197338 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.