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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04503200

Collaborator

(none)

Enrollment

Location

Arms

24.5

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography Common Bile Duct Diseases Transpancreatic Precut Precut Double Guidewire	Procedure: Double guidewire Procedure: Transpancreatic precut	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 15, 2020

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Double guidewire	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.
Active Comparator: Transpancreatic precut	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: Double guidewire

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.

Active Comparator: Transpancreatic precut

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	11562

Sponsors and Collaborators

Cairo University

Investigators

Study Chair: Hany M Shehab, Kasr-Elaini Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hany Shehab, Professor, Cairo University

ClinicalTrials.gov Identifier:

NCT04503200

Other Study ID Numbers:

DGWRCT

First Posted:

Aug 7, 2020

Last Update Posted:

Aug 7, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bile Duct Diseases

Common Bile Duct Diseases

Study Results

No Results Posted as of Aug 7, 2020