Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedStudy Start
First participant enrolled
August 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedAugust 7, 2020
August 1, 2020
2 years
August 4, 2020
August 4, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Cannulation success
Proportion of patients with successful cannulation of the common bile duct
Within 10 minutes
Rate of post-ERCP pancreatitis
Proportion of patients suffering post-ERCP pancreatitis
up to 24 hours after the procedure
Secondary Outcomes (1)
Time to successful cannulation
Within 10 minutes
Study Arms (2)
Double guidewire
ACTIVE COMPARATORTranspancreatic precut
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- unintentional cannulation of the pancreatic duct 3 times
- Consenting to join the study
You may not qualify if:
- Previous ERCP with or without previous sphincterotomy
- Known coagulopathy
- \- Pregnancy
- \- Known acute pancreatitis at the time of procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, 11562, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hany M Shehab
Kasr-Elaini Faculty of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 4, 2020
First Posted
August 7, 2020
Study Start
August 15, 2020
Primary Completion
July 31, 2022
Study Completion
August 30, 2022
Last Updated
August 7, 2020
Record last verified: 2020-08