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Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage

NCT01789502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2015-08-04

No results posted yet for this study

Summary

This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.

Conditions

  • Periampullary Cancer
  • Complications of Surgical Procedures or Medical Care
  • Disorder of Bile Duct Stent

Interventions

DEVICE

Fully covered metal stents

Fully covered metal stents were inserted by ERCP

DEVICE

Plastic stents

Plastic stents were inserted by ERCP

Sponsors & Collaborators

  • Inje University

    lead OTHER

Principal Investigators

  • Tae Jun Song, MD, PhD · Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01789502 on ClinicalTrials.gov