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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290769
Recruitment Status : Suspended (Hospital administrative problems)
First Posted : November 14, 2014
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatitis Device: Short guide wire rapid exchange Device: Long guide wire Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial
Actual Study Start Date : January 28, 2018
Actual Primary Completion Date : January 28, 2018
Estimated Study Completion Date : March 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of post ERCP pancreatitis [ Time Frame: 8 hours post ERCP ]
    Incidence of post ERCP pancreatitis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290769


Locations
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Italy
Niguarda Hospital
Milano, Italy, 20100
Sponsors and Collaborators
Niguarda Hospital
Investigators
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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
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Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT02290769    
Other Study ID Numbers: 382 - 072014
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Niguarda Hospital:
Guide wire cannulation ERCP
Time of cannulation
Rapid exchange guide wire
Guide wire
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases