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

Phase 4

Completed

• Conditions: Pancreatitis; Cholangitis; Cholecystitis
• Interventions: Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide

• Registration Number: NCT01744847
• Lead Sponsor: Soon Chun Hyang University

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 Timeline

• Study Start: 2005-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-11-09
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-06
• Last Update Submitted: 2012-12-06
• Study First Posted: 2012-12-07
• Last Update Posted: 2012-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DGT, Tracer Metro® Direct™ Wire Guide	Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide	Double guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide
TPS, Tracer Hybrid® Wire Guides	Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide	trans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides

Primary Outcome Measures

Name	Time	Method
success rate between DGT and TPS	up to 22months	from October 2010 to August 2012

Secondary Outcome Measures

Name	Time	Method
median cannulation time between DGT and TPS	during precedure time	median time for precedure

Trial Locations

Locations (1)

Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital; 🇰🇷 Seoul, Yongsan-gu, Korea, Republic of