Early Precut in Difficult Biliary Cannulation

November 5, 2015 updated by: Testoni Pier Alberto, Università Vita-Salute San Raffaele

Early Precut Sphincterotomy During ERCP With Difficult Biliary Access (Italian: Esecuzione Del Pre-cut Precoce in Corso di ERCP Con Difficoltosa Incannulazione Della Via Biliare)

This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").

Study Type

Interventional

Enrollment (Actual)

375

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, 20132
        • San Raffaele Hospital

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 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP.

Exclusion Criteria:

  • active cholangitis or pancreatitis
  • chronic pancreatitis,
  • previous sphincterotomy,
  • prior gastric surgery,
  • coagulopathy,
  • severe comorbidity (need for tracheal intubation)
  • patients who refused or were unable to give informed consent.
  • patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD) (arbitrarily defined as "easy CBD cannulation"),
  • detection of ampulloma or peri-papillary diverticula during ERCP.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
Early Precut
Procedure: Early Precut
Early precut was performed during ERCP with difficult biliary cannulation
ACTIVE_COMPARATOR: Group B
Prolonged cannulation attempts
Procedure: Prolonged cannulation attempts
Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of PEP
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of overall complications
Time Frame: 24 hours
The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.
24 hours

Collaborators and Investigators

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

Sponsor

Università Vita-Salute San Raffaele

Collaborators

Valduce Hospital
Istituti Ospitalieri di Cremona
Azienda Ospedaliera Universitaria Senese
Papa Giovanni XXIII Hospital
San Giuseppe Moscati Hospital
Cardarelli Hospital
Maresca Hospital

Investigators

  • Principal Investigator: Pier Alberto Testoni, Professor, San Raffaele Hospital

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

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (ESTIMATE)

November 4, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECUT PRECOCE/01

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.

Clinical Trials on Common Bile Duct Diseases

Clinical Trials on Early Precut

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe