Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation (ERCP)
Primary Purpose
Jaundice, Obstructive
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional ERCP
Precut ERCP
Sponsored by
About this trial
This is an interventional treatment trial for Jaundice, Obstructive
Eligibility Criteria
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
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
conventional ERCP
Precut ERCP
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Successful biliary cannulations
Successful cannulations of biliary system if the guide wire enter the common bile duct
Secondary Outcome Measures
postprocedure pancreatitis
elevated serum amylase with abdominal pain
postprocedure perforation
duodenal perforation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02477228
Brief Title
Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation
Acronym
ERCP
Official Title
Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation. A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional ERCP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Precut ERCP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional ERCP
Other Intervention Name(s)
G1
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Precut ERCP
Other Intervention Name(s)
G 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful biliary cannulations
Description
Successful cannulations of biliary system if the guide wire enter the common bile duct
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
postprocedure pancreatitis
Description
elevated serum amylase with abdominal pain
Time Frame
30 day
Title
postprocedure perforation
Description
duodenal perforation
Time Frame
30 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayman el nakeeb, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
2070995
Citation
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.
Results Reference
result
PubMed Identifier
10570335
Citation
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.
Results Reference
result
PubMed Identifier
23313840
Citation
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.
Results Reference
result
PubMed Identifier
15054501
Citation
Carr-Locke DL. Biliary access during endoscopic retrograde cholangiopancreatography. Can J Gastroenterol. 2004 Apr;18(4):251-4. doi: 10.1155/2004/364056.
Results Reference
result
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Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation
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