Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique (loop)

September 23, 2014 updated by: Enzo Masci, Azienda Ospedaliera San Paolo

Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients

The purpose of this 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 post-ERCP pancreatitis in high-risk patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access 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.

Type of study: Multicentric, prospective and randomized trial

Patients: PEP high-risk patients underwent ERCP for benign biliary pathology

Number of patients: 320 patients (160 for each group)

Aim:

Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

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 to 90 years (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 yrs
  • allergy to the contrast medium
  • previous surgery
  • neoplastic bilio-pancreatic disease
  • previous EBS

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERCP with loop tip wire
ERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis.
Device: ERCP with loop tip wire
Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation
Active Comparator: ERCP for cannulation
ERCP for cannulation of CBD with traditional technique
Device: ERCP for cannulation
Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The evaluation of the incidence of PEP
Time Frame: loop20216
loop20216

Secondary Outcome Measures

Outcome Measure
Time Frame
The evaluation of CBD percentage cannulation.
Time Frame: loop20216
loop20216

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera San Paolo

Investigators

  • Study Director: Enzo Masci, MD, Hospital San Paolo

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

November 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • loop20216

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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