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

Not Applicable

• Conditions: Endoscopic Retrograde Cholangiopancreatography; Common Bile Duct Diseases; Transpancreatic Precut; Precut; Double Guidewire
• Interventions: Procedure: Transpancreatic precut; Procedure: Double guidewire

• Registration Number: NCT04503200
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Study First Posted: 2020-08-07
• Last Update Posted: 2020-08-07
• Study Start: 2020-08-15
• Primary Completion: 2022-07-31
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transpancreatic precut	Transpancreatic precut	-
Double guidewire	Double guidewire	-

Primary Outcome Measures

Name	Time	Method
Cannulation success	Within 10 minutes	Proportion of patients with successful cannulation of the common bile duct
Rate of post-ERCP pancreatitis	up to 24 hours after the procedure	Proportion of patients suffering post-ERCP pancreatitis

Secondary Outcome Measures

Name	Time	Method
Time to successful cannulation	Within 10 minutes	Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt