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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endoscopic Retrograde Cholangiopancreatography, Common Bile Duct Diseases, Transpancreatic Precut, Precut, Double Guidewire

Intervention / Treatment
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* Procedure: Double guidewire
* Procedure: Transpancreatic precut


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Double guidewire<br> | Procedure: Double guidewire<br>* 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.<br>|
| Active Comparator: Transpancreatic precut<br> | Procedure: Transpancreatic precut<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to successful cannulation | Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct | Within 10 minutes |