Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation
NCT ID: NCT02477228
Last Updated: 2015-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2014-01-31
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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conventional 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.
conventional 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.
Precut 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.
Precut 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.
Interventions
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conventional 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.
Precut 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Ayman El Nakeeb
Gastroenterology surgical center
Principal Investigators
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ayman el nakeeb, MD
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Locations
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Mansoura University
Al Mansurah, , Egypt
Countries
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References
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Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
Cortas GA, Mehta SN, Abraham NS, Barkun AN. Selective cannulation of the common bile duct: a prospective randomized trial comparing standard catheters with sphincterotomes. Gastrointest Endosc. 1999 Dec;50(6):775-9. doi: 10.1016/s0016-5107(99)70157-4.
Swan MP, Alexander S, Moss A, Williams SJ, Ruppin D, Hope R, Bourke MJ. Needle knife sphincterotomy does not increase the risk of pancreatitis in patients with difficult biliary cannulation. Clin Gastroenterol Hepatol. 2013 Apr;11(4):430-436.e1. doi: 10.1016/j.cgh.2012.12.017. Epub 2013 Jan 11.
Carr-Locke DL. Biliary access during endoscopic retrograde cholangiopancreatography. Can J Gastroenterol. 2004 Apr;18(4):251-4. doi: 10.1155/2004/364056.
Other Identifiers
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Biliary cannulation
Identifier Type: -
Identifier Source: org_study_id
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