MedTrace Logo

Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture

NCT01125865 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-03-10

No results posted yet for this study

Summary

The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months.

There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction.

The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.

Conditions

  • Bile Duct Obstruction
  • Klatskin's Tumor

Interventions

DEVICE

SEMS insertion

Self-expandable metallic stent will be inserted for malignant hilar obstruction.

DEVICE

DLS insertion

DoubleLayer plastic stent will be inserted for malignant hilar obstruction.

Sponsors & Collaborators

  • Soon Chun Hyang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-07-31
Completion
2011-12-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT01125865 on ClinicalTrials.gov