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NCT04503200 Clinical Trial

Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:
Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04503200
Other study ID # DGWRCT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 15, 2020
Est. completion date August 30, 2022

Study information
Verified date August 2020
Source Cairo University
Contact Hany Shehab
Phone 01111111071
Email h.shehab@kasralainy.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date August 30, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Double guidewire
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.
• Transpancreatic precut
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.

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cannulation success Proportion of patients with successful cannulation of the common bile duct Within 10 minutes
Primary Rate of post-ERCP pancreatitis Proportion of patients suffering post-ERCP pancreatitis up to 24 hours after the procedure
Secondary Time to successful cannulation Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct Within 10 minutes
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