DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study
Primary Purpose
Pancreatitis, Cholangitis, Cholecystitis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis
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.
Sites / Locations
- Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
DGT, Tracer Metro® Direct™ Wire Guide
TPS, Tracer Hybrid® Wire Guides
Arm Description
Double guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide
trans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides
Outcomes
Primary Outcome Measures
success rate between DGT and TPS
from October 2010 to August 2012
Secondary Outcome Measures
median cannulation time between DGT and TPS
median time for precedure
Full Information
NCT ID
NCT01744847
First Posted
November 9, 2012
Last Updated
December 6, 2012
Sponsor
Soon Chun Hyang University
1. Study Identification
Unique Protocol Identification Number
NCT01744847
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soon Chun Hyang University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Cholangitis, Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DGT, Tracer Metro® Direct™ Wire Guide
Arm Type
Active Comparator
Arm Description
Double guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide
Arm Title
TPS, Tracer Hybrid® Wire Guides
Arm Type
Active Comparator
Arm Description
trans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides
Intervention Type
Device
Intervention Name(s)
Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
Other Intervention Name(s)
Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide
Intervention Description
one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation
Primary Outcome Measure Information:
Title
success rate between DGT and TPS
Description
from October 2010 to August 2012
Time Frame
up to 22months
Secondary Outcome Measure Information:
Title
median cannulation time between DGT and TPS
Description
median time for precedure
Time Frame
during precedure time
Other Pre-specified Outcome Measures:
Title
pancreatitis rate between DGT and TPS
Description
We observation for the comlication upto 1 week after ERCP
Time Frame
upto 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital
City
Seoul
State/Province
Yongsan-gu
ZIP/Postal Code
140-743
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study
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