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Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

NCT03849859 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-04-01

No results posted yet for this study

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent placement is crucial for palliative treatment in patients with malignant bile duct obstruction who cannot perform surgery due to advanced diseases or associated comorbidities. Stent patency is challenge in ERCP. Self expanding metallic stents (SEMS) have a longer duration of patency and fewer of recurrence occlusion of stent when compared with plastic stent (PS). However, the cost of MS is more expensive than PS about 4 times. Therefore, many patients cannot afford the MS due to their economic status. Data regarding the efficacy and safety of multiple PS compared with single PS for the palliative treatment in unresectable malignant distal bile duct obstruction are limited.

Conditions

  • Plastic Stent Occlusion

Interventions

DEVICE

Single plastic stent

Deployment of single plastic stent

DEVICE

Multiple plastic stents

Deployment of multiple plastic stents

Sponsors & Collaborators

  • Prince of Songkla University

    lead OTHER

Principal Investigators

  • Ni Netinatsunton, M.D. · NKC Institute of Gastroenterology and Hepatology.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-05-01
Completion
2020-11-30

Countries

  • Thailand

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 NCT03849859 on ClinicalTrials.gov