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Efficacy of Partial Covered Double Bare Metal Stent Compared to Uncovered Double Bare Metal Stent in Malignant Biliary Obstruction

NCT02937246 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2019-06-24

No results posted yet for this study

Summary

Previous studies indicated that covered stents are less likely to become occluded in comparison to bare stents. While the probability of occlusions caused by tumor in-growth is less in covered stents, they are more likely to spontaneously migrate to a position that is distal to the original deployment site. However, newer covered stents with improved designs, such as the partially covered double bare metallic stent used for this study, include features to mitigate the migration issue. The purpose of this study is to confirm whether the difference in patency rate between regular covered stents and bare stents, which has already been well established by existing studies, is also reproducible when double covered stents are compared against double bare stents.

Conditions

  • Malignant Tumor

Interventions

DEVICE

SEMS(self-expandable metallic stent)

Find the obstruction site by ERCP(endoscopic retrograde cholangiopancreatography) and insertion the SEMS(self-expandable metallic stent) through duodenal endoscopy. Metal stents are inserted to ensure adequate decompression and bile drainage. The diameter and stent lengths can be changed according to the lesion.

DEVICE

Stenting by ERCP (endoscopic retrograde cholangiopancreatography)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-12-31
Completion
2019-12-31

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 NCT02937246 on ClinicalTrials.gov