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

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

Sponsors

Lead Sponsor: Cairo University

Source Cairo University
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.

Overall Status Not yet recruiting
Start Date August 15, 2020
Completion Date August 30, 2022
Primary Completion Date July 31, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cannulation success Within 10 minutes
Rate of post-ERCP pancreatitis up to 24 hours after the procedure
Secondary Outcome
Measure Time Frame
Time to successful cannulation Within 10 minutes
Enrollment 80
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Double guidewire

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.

Arm Group Label: Double guidewire

Intervention Type: Procedure

Intervention Name: Transpancreatic precut

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.

Arm Group Label: Transpancreatic precut

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Hany M Shehab Study Chair Kasr-Elaini Faculty of Medicine
Overall Contact

Last Name: Hany Shehab

Phone: 01111111071

Email: [email protected]

Location
Facility: Contact: Investigator: Cairo University Hany M Shehab, MD 01111111071 [email protected] Hany M Shehab, FRCP Principal Investigator
Location Countries

Egypt

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cairo University

Investigator Full Name: Hany Shehab

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Double guidewire

Type: Active Comparator

Label: Transpancreatic precut

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov