Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation

Study Overview
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Brief Summary
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Endoscopic sphincterotomy is now an established method for removal of common bile duct calculi and treatment of papillary stenosis, the sump syndrome and certain cases of ampullary carcinoma. It is also generally performed prior to biliary stent placement .Anatomical variations, papillary stenosis, impacted stones, ampullary tumors, duodenal diverticula, and post-gastrojejunostomy states are some of the reasons behind difficult common bile duct (CBD) cannulations . In these situations, the success of CBD cannulation can be enhanced slightly by using the various accessories designed for this purpose.The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication

Detailed Description
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The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication This a prospective randomized controlled trial comparing two groups of patients who undergo endoscopic retrograde cholangiopancreatography for obstructive jaundice in Gastrointestinal Surgical center, Mansoura University, Egypt. From January 2014 to December 2014. Group A consists of 50 patients who will undergo conventional approach and group B consists of 50 patients who undergo needle knife fistulotomy for cannulation of the ampulla of Vater. Randomization was done by paramedical personnel in the ERCP unit by taking a number from an envelope. Data will be registered in a specially prepared sheet for the purpose of the study. Registered data will include: duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. Data also included postoperative hospital stay, serum amylase level and postoperative complications as pancreatitis, perforation, bleeding and cholecystitis. Pancreatitis will be also graded according to its severity depending on the duration of hospital stay.

Official Title
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Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation. A Prospective Randomized Study

Conditions
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Jaundice, Obstructive

Intervention / Treatment
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* Procedure: conventional ERCP
* Procedure: Precut ERCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients (no limit of age) required ERCP calculator and malignant obstructive jaundice Exclusion Criteria: unfit patients history of gastrectomy bleeding tendency larg tumour infiltrating the duodenum
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: conventional ERCP<br>ERCP was done through the papilla. duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. | Procedure: conventional ERCP<br>* ERCP was done through the papilla. duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.<br>* Other names: G1;|
| Active Comparator: Precut ERCP<br>ERCP was done through precut from the start duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. | Procedure: Precut ERCP<br>* ERCP was done through precut from the start duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.<br>* Other names: G 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful biliary cannulations | Successful cannulations of biliary system if the guide wire enter the common bile duct | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprocedure pancreatitis | elevated serum amylase with abdominal pain | 30 day | 
| postprocedure perforation | duodenal perforation | 30 day |