Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-01-31

Brief Summary

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Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.

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Detailed Description

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Conditions

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Post-ERCP Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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loop-tip arm

The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.)

Group Type EXPERIMENTAL

Loop-tip wire (Cook Medical) for the cannulation of the CBD

Intervention Type DEVICE

Control arm

The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique)

Group Type ACTIVE_COMPARATOR

Cannulotome CT-25mm Cook Medical

Intervention Type DEVICE

Interventions

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Loop-tip wire (Cook Medical) for the cannulation of the CBD

Intervention Type DEVICE

Cannulotome CT-25mm Cook Medical

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* high-risk patients for post-ERCP pancreatitis

Exclusion Criteria

* age \< 18 years
* allargy to the contrast medium
* previous biliary or gastric surgery
* neoplastic patients
* previous biliary or pancreatic sphincterotomy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No