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.

Study Overview

• Status: Completed
• Conditions: Cholecystitis; Pancreatitis; Cholangitis
• Intervention / Treatment: Device: Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide

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 Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yongsan-gu
    • Seoul, Yongsan-gu, Korea, Republic of, 140-743
      • Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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: TPS, Tracer Hybrid® Wire Guides; trans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pancreatitis rate between DGT and TPS	We observation for the comlication upto 1 week after ERCP	upto 1 week

Collaborators and Investigators

• Sponsor: Soon Chun Hyang University

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: November 9, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (Estimate): December 7, 2012

Study Record Updates

• Last Update Posted (Estimate): December 7, 2012
• Last Update Submitted That Met QC Criteria: December 6, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Cholecystitis; Pancreatitis; Cholangitis
• Other Study ID Numbers: MD-2012-010