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DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lee Woong Cheul, Soon Chun Hyang University
ClinicalTrials.gov Identifier:
NCT01744847
First received: November 9, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatitis
Cholangitis
Cholecystitis
 Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Randomized Multi-center Study

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • success rate between DGT and TPS [ Time Frame: up to 22months ] [ Designated as safety issue: Yes ]
    from October 2010 to August 2012


Secondary Outcome Measures:
  • median cannulation time between DGT and TPS [ Time Frame: during precedure time ] [ Designated as safety issue: Yes ]
    median time for precedure


Other Outcome Measures:
  • pancreatitis rate between DGT and TPS [ Time Frame: upto 1 week ] [ Designated as safety issue: Yes ]
    We observation for the comlication upto 1 week after ERCP


Enrollment: 111
Study Start Date: January 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DGT, Tracer Metro® Direct™ Wire Guide
Double guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide
 Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation
Other Names:
  • Tracer Hybrid® Wire Guides
  • Tracer Metro® Direct™ Wire Guide
Active Comparator: TPS, Tracer Hybrid® Wire Guides
trans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides
 Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation
Other Names:
  • Tracer Hybrid® Wire Guides
  • Tracer Metro® Direct™ Wire Guide

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744847

Locations
Korea, Republic of
Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital
Seoul, Yongsan-gu, Korea, Republic of, 140-743
Sponsors and Collaborators
Soon Chun Hyang University
  More Information

No publications provided

Responsible Party: Lee Woong Cheul, fellow of gastroenterology, Soon Chun Hyang University
ClinicalTrials.gov Identifier: NCT01744847     History of Changes
Other Study ID Numbers: MD-2012-010
Study First Received: November 9, 2012
Last Updated: December 6, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Cholangitis
Cholecystitis
Acalculous Cholecystitis
Pancreatitis
Bile Duct Diseases
 Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013