Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire (RELG)

April 13, 2026 updated by: Niguarda Hospital

Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial

The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis.

Aim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients

Study Type

Interventional

Enrollment (Estimated)

292

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, 20100
        • Niguarda 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • indication to primary ERCP
  • ASA (American Society of Anesthesiologists) 1, 2, 3

Exclusion Criteria:

  • pancreas neoplasia
  • pancreatitis
  • ampulloma
  • duodenum stenosis
  • under mucous membrane haematoma

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short guide wire rapid exchange
Use of short guide wire rapid exchange to guide the cannulation during primary ERCP
Device: Short guide wire rapid exchange
Use of short guide wire rapid exchange to guide the cannulation during primary ERCP
Active Comparator: Long guide wire
Use of long wire to guide the cannulation during primary ERCP
Device: Long guide wire
Use of long wire to guide the cannulation during primary ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of cannulation
Time Frame: 8 hours from intervention
Time (in seconds) required to perform a complete and successful deep cannulation of the "biliary papilla" and the biliary tree assessed by timing it and reporting it in the prefashioned database
8 hours from intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post ERCP pancreatitis
Time Frame: 8 hours post ERCP
Incidence of post ERCP pancreatitis
8 hours post ERCP

Collaborators and Investigators

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

Sponsor

Niguarda Hospital

Investigators

  • Study Chair: Francesco Pugliese, MD, Niguarda Ca' Granda Hospital
  • Study Chair: Edoardo Forti, MD, Niguarda Ca' Granda Hospital
  • Study Chair: Raffaele Manta, MD, Niguarda Ca' Granda 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 (Actual)

January 28, 2018

Primary Completion (Actual)

January 28, 2018

Study Completion (Estimated)

December 14, 2026

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimated)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 382 - 072014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Pancreatitis

Clinical Trials on Short guide wire rapid exchange

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe