Back to resultsTime of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire (RELG)
Primary Purpose
Pancreatitis
Status
Suspended
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Short guide wire rapid exchange
Long guide wire
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis focused on measuring Guide wire cannulation ERCP, Time of cannulation, Rapid exchange guide wire, Guide wire
Eligibility 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
Sites / Locations
- Niguarda Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Short guide wire rapid exchange
Long guide wire
Arm Description
Use of short guide wire rapid exchange to guide the cannulation during primary ERCP
Use of long wire to guide the cannulation during primary ERCP
Outcomes
Primary Outcome Measures
Time of cannulation
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
Incidence of post ERCP pancreatitis
Incidence of post ERCP pancreatitis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02290769
Brief Title
Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire
Acronym
RELG
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Hospital administrative problems
Study Start Date
January 28, 2018 (Actual)
Primary Completion Date
January 28, 2018 (Actual)
Study Completion Date
December 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niguarda Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Guide wire cannulation ERCP, Time of cannulation, Rapid exchange guide wire, Guide wire
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
292 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short guide wire rapid exchange
Arm Type
Experimental
Arm Description
Use of short guide wire rapid exchange to guide the cannulation during primary ERCP
Arm Title
Long guide wire
Arm Type
Active Comparator
Arm Description
Use of long wire to guide the cannulation during primary ERCP
Intervention Type
Device
Intervention Name(s)
Short guide wire rapid exchange
Intervention Description
Use of short guide wire rapid exchange to guide the cannulation during primary ERCP
Intervention Type
Device
Intervention Name(s)
Long guide wire
Intervention Description
Use of long wire to guide the cannulation during primary ERCP
Primary Outcome Measure Information:
Title
Time of cannulation
Description
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
Time Frame
8 hours from intervention
Secondary Outcome Measure Information:
Title
Incidence of post ERCP pancreatitis
Description
Incidence of post ERCP pancreatitis
Time Frame
8 hours post ERCP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Pugliese, MD
Organizational Affiliation
Niguarda Ca' Granda Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Edoardo Forti, MD
Organizational Affiliation
Niguarda Ca' Granda Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Raffaele Manta, MD
Organizational Affiliation
Niguarda Ca' Granda Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Niguarda Hospital
City
Milano
ZIP/Postal Code
20100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire
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