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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

November 9, 2012
December 6, 2012
January 2005
August 2012   (final data collection date for primary outcome measure)
success rate between DGT and TPS [ Time Frame: up to 22months ] [ Designated as safety issue: Yes ]
from October 2010 to August 2012
Same as current
Complete list of historical versions of study NCT01744847 on ClinicalTrials.gov Archive Site
median cannulation time between DGT and TPS [ Time Frame: during precedure time ] [ Designated as safety issue: Yes ]
median time for precedure
Same as current
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
Same as current
 
DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study
DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Randomized Multi-center Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Pancreatitis
  • Cholangitis
  • Cholecystitis
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: DGT, Tracer Metro® Direct™ Wire Guide
    Double guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide
    Intervention: Device: 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
    Intervention: Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01744847
MD-2012-010
Yes
Lee Woong Cheul, Soon Chun Hyang University
Soon Chun Hyang University
Not Provided
Not Provided
Soon Chun Hyang University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP