An interventional study of conventional ERCP and Precut ERCP in Jaundice, Obstructive, sponsored by Mansoura University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2015-06-22.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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
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.
63 studies on the registry are indexed under Jaundice, Obstructive; 14 are open to participants now.
This study's enrollment of 100 is above the median of 70 across 41 interventional studies indexed under Jaundice, Obstructive.
Browse Jaundice, Obstructive studies →Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
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.
Also known as: G1
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.
Also known as: G 2
Successful biliary cannulations
Successful cannulations of biliary system if the guide wire enter the common bile duct
Time frame: 1 Day
postprocedure pancreatitis
elevated serum amylase with abdominal pain
Time frame: 30 day
postprocedure perforation
duodenal perforation
Time frame: 30 day
The record gives a start of Jan 2014, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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