Back to resultsDouble Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.
Primary Purpose
Endoscopic Retrograde Cholangiopancreatography, Common Bile Duct Diseases, Transpancreatic Precut
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Double guidewire
Transpancreatic precut
Sponsored by
About this trial
This is an interventional treatment trial for Endoscopic Retrograde Cholangiopancreatography
Eligibility Criteria
Inclusion Criteria:
- unintentional cannulation of the pancreatic duct 3 times
- Consenting to join the study
Exclusion Criteria:
- Previous ERCP with or without previous sphincterotomy
Known coagulopathy
- - Pregnancy
- - Known acute pancreatitis at the time of procedure
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Double guidewire
Transpancreatic precut
Arm Description
Outcomes
Primary Outcome Measures
Cannulation success
Proportion of patients with successful cannulation of the common bile duct
Rate of post-ERCP pancreatitis
Proportion of patients suffering post-ERCP pancreatitis
Secondary Outcome Measures
Time to successful cannulation
Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04503200
Brief Title
Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.
Official Title
Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2020 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures. This frequently happens in the form of repeated unintentional cannulation of the pancreatic duct. Two valid options are available to facilitate cannulation at this point: Double guidewire technique or performing a transpancreatic precut. This is a randomized trial comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut after three unintentional passages of the guidewire into the pancreatic duct.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Retrograde Cholangiopancreatography, Common Bile Duct Diseases, Transpancreatic Precut, Precut, Double Guidewire
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Double guidewire
Arm Type
Active Comparator
Arm Title
Transpancreatic precut
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Double guidewire
Intervention Description
After the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct.
Intervention Type
Procedure
Intervention Name(s)
Transpancreatic precut
Intervention Description
After the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct.
Primary Outcome Measure Information:
Title
Cannulation success
Description
Proportion of patients with successful cannulation of the common bile duct
Time Frame
Within 10 minutes
Title
Rate of post-ERCP pancreatitis
Description
Proportion of patients suffering post-ERCP pancreatitis
Time Frame
up to 24 hours after the procedure
Secondary Outcome Measure Information:
Title
Time to successful cannulation
Description
Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct
Time Frame
Within 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unintentional cannulation of the pancreatic duct 3 times
Consenting to join the study
Exclusion Criteria:
Previous ERCP with or without previous sphincterotomy
Known coagulopathy
- Pregnancy
- Known acute pancreatitis at the time of procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany Shehab
Phone
01111111071
Email
h.shehab@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany M Shehab
Organizational Affiliation
Kasr-Elaini Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany M Shehab, MD
Phone
01111111071
Email
H.shehab@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Hany M Shehab, FRCP
12. IPD Sharing Statement
Learn more about this trial
Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.
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