DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study
1 other identifier
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 9, 2012
CompletedFirst Posted
Study publicly available on registry
December 7, 2012
CompletedDecember 7, 2012
December 1, 2012
7.6 years
November 9, 2012
December 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
success rate between DGT and TPS
from October 2010 to August 2012
up to 22months
Secondary Outcomes (1)
median cannulation time between DGT and TPS
during precedure time
Other Outcomes (1)
pancreatitis rate between DGT and TPS
upto 1 week
Study Arms (2)
DGT, Tracer Metro® Direct™ Wire Guide
ACTIVE COMPARATORDouble guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide
TPS, Tracer Hybrid® Wire Guides
ACTIVE COMPARATORtrans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides
Interventions
one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation
Eligibility Criteria
You may qualify if:
- ERCP patient, over 20 years old, pancreatic duct cannulation patients by chance
You may not qualify if:
- refuse the ERCP, post procedure state(EST, subtotal gastrectomy, Whipples' Op except gastroduodenostomy), use another method, under 20 years old.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital
Seoul, Yongsan-gu, 140-743, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- fellow of gastroenterology
Study Record Dates
First Submitted
November 9, 2012
First Posted
December 7, 2012
Study Start
January 1, 2005
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
December 7, 2012
Record last verified: 2012-12