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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatitis, Cholangitis, Cholecystitis

Intervention / Treatment
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* Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DGT, Tracer Metro® Direct™ Wire Guide<br>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<br>* one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation<br>* Other names: Tracer Metro® Direct™ Wire Guide;|
| Active Comparator: TPS, Tracer Hybrid® Wire Guides<br>trans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides | Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide<br>* one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation<br>* Other names: Tracer Metro® Direct™ Wire Guide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate between DGT and TPS | from October 2010 to August 2012 | up to 22months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median cannulation time between DGT and TPS | median time for precedure | during precedure time |