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

NCT ID: NCT01744847

Last Updated: 2012-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2012-08-31

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.

Conditions

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Pancreatitis Cholangitis Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DGT, Tracer Metro® Direct™ Wire Guide

Double guide wire technique was performed by Tracer Hybrid® Wire Guides and Tracer Metro® Direct™ Wire Guide

Group Type ACTIVE_COMPARATOR

Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide

Intervention Type DEVICE

one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation

TPS, Tracer Hybrid® Wire Guides

trans pancreatic sphincterotomy was performed by Tracer Hybrid® Wire Guides

Group Type ACTIVE_COMPARATOR

Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide

Intervention Type DEVICE

one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Tracer Hybrid® Wire Guides Tracer Metro® Direct™ Wire Guide

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soon Chun Hyang University

OTHER

Sponsor Role lead

Responsible Party

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Lee Woong Cheul

fellow of gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Digestive Research, Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital

Seoul, Yongsan-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MD-2012-010

Identifier Type: -

Identifier Source: org_study_id