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NCT01792466 · ClinicalTrials.gov registry record · NA

RCT of the Double Wire Technique for Sphincterotomy

A NA study, sponsored by Mayo Clinic.

Terminated
Registry status
NA
Development phase
16
Enrollment target

NCT01792466: Clinical Trial NA study, sponsored by Mayo Clinic.

NCT01792466 is a NA study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01792466, a NA study, was terminated before completion, sponsored by Mayo Clinic.

TERMINATED
Registry status
NA
Development phase
16 participants
Enrollment target

Study Summary

Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening. Therapy on the biliary tree, like for example stone removal, frequently requires inserting tools through the opening of the duct and cutting of the muscle which control the secretion of juices from the liver. Cutting the muscle helps with securing an easy access to the bile duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly because it straightens the duct. On certain occasions this also fails and we resort to cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile duct. The more attempt to enter the bile duct the higher the risk of inflammation in the pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct opening. The study is trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct immediately after a wire has entered the pancreatic duct will make it easier to place the wire in the bile duct as compared to trying to place the wire in the bile duct without cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated attempts at accessing the bile duct can also inc

Primary Outcome

Number of attempts needed to achieve deep cannulation with a second wire.

Interventions

  • PROCEDURE Transpancreatic sphincterotomy

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2013-02
Est. Completion 2016-11
Phase NA
Mayo Clinic

2,844 total trials

Why NCT01792466 stopped before completion

NCT01792466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Transpancreatic sphincterotomy is the first listed.

NCT01792466 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01792466 about?

NCT01792466 is a clinical study titled "RCT of the Double Wire Technique for Sphincterotomy". Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life ...

What is the current status of trial NCT01792466?

This trial is currently terminated. It is a NA study. The enrollment target is 16 participants. The study started on 2013-02. Estimated completion is 2016-11.

What interventions are being tested in trial NCT01792466?

The interventions under investigation include: Transpancreatic sphincterotomy (PROCEDURE).

Who is sponsoring clinical trial NCT01792466?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01792466's enrollment target sits among peer trials

16 1871st of 2000 higher than 120 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 NCT01792466, the US trial registry maintained by the National Library of Medicine. NCT01792466 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.