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

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 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

NCT ID

NCT01744847

Organization ID

MD-2012-010

Responsible Party

Principal Investigator

Study Sponsor

Soon Chun Hyang University

Study Sponsor

, , 

Verification Date

December 2012