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

January 16, 2013 updated by: Benedetto Mangiavillano, Hospital San Paolo
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20142
        • Recruiting
        • San Paolo Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: loop-tip arm
The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.)
Device: Loop-tip wire (Cook Medical) for the cannulation of the CBD
ACTIVE_COMPARATOR: Control arm
The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique)
Device: Cannulotome CT-25mm Cook Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post ERCP pancreatitis rate
Time Frame: up to 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability
Time Frame: up to 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Paolo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ANTICIPATED)

February 1, 2013

Study Completion (ANTICIPATED)

January 1, 2014

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (ESTIMATE)

January 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H San Paolo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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