Brief Title
DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study
Official Title
DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Randomized Multi-center Study
Brief Summary
In patients with pancreatic duct cannulation initially by chance, double guide wire technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar success rates. The incidence of post-procedure pancreatitis was similar in the two groups, but post-procedure hyperamylasemia was significantly higher in the DGT group.
Detailed Description
This was a prospective, randomized study conducted in three tertiary referral hospital in Korea. Three endoscopists performed the ERCP who had ERCP experience more than ten years From October 2010 to August 2012, ERCPs were performed on patients with pancreatobiliary diseases at Soonchunhyang University Seoul Hospital, Hanyang University Guri Hospital and Kosin University Gospel Hospital. Bile duct cannulation was attempted for various reasons (removal of bile duct stones, biliary stenting, cytology of bile, biopsy of the bile duct, etc.). Patients who satisfied the following inclusion criteria were enrolled in this study: (1) initially pancreatic duct cannulation by chance, (2) successful insertion of the guidewire into the pancreatic duct to at least half of the presumed total length of the pancreatic duct,, and (3) age 20 years or older. Exclusion criteria were: (1) refusal the ERCP, (2) previous endoscopic sphincterotomy or endoscopic papillary balloon dilatation, (3) acute pancreatitis at the time of the procedure, (4) pregnancy and (5) anatomical change due to past surgery; total gastrectomy, Billroth II operation, Whipples's operation etc. Patients who satisfied the inclusion criteria were randomly assigned to either the double-guidewire technique (DGT) group or the transpancreatic precut sphincterotomy (TPS) group; A randomization list for group allocation was generated by using computer-based pseudo-random number generators. We compared both techniques , for a maximum of ten extra attempts which are CBD cannulation by each methods. We obtained the written informed consent from all enrolled patients.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
success rate between DGT and TPS
Secondary Outcome
median cannulation time between DGT and TPS
Condition
Pancreatitis
Intervention
Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
Study Arms / Comparison Groups
DGT, Tracer Metro® Direct™ Wire Guide
Description: Double guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
111
Start Date
January 2005
Completion Date
August 2012
Primary Completion Date
August 2012
Eligibility Criteria
Inclusion Criteria: - ERCP patient, over 20 years old, pancreatic duct cannulation patients by chance Exclusion Criteria: - refuse the ERCP, post procedure state(EST, subtotal gastrectomy, Whipples' Op except gastroduodenostomy), use another method, under 20 years old.
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01744847
Organization ID
MD-2012-010
Responsible Party
Principal Investigator
Study Sponsor
Soon Chun Hyang University
Study Sponsor
, ,
Verification Date
December 2012