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Clinical Trials/NCT02659852
NCT02659852UnknownNot Applicable

A Prospective Randomized Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

Yonsei University2 sites in 1 country70 target enrollmentStarted: January 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
70
Locations
2
Primary Endpoint
Median patency duration

Study Overview

Brief Summary

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. Biliary drainage and stent patency was a little superior in side by side than stent in stent. But, complication related with bilateral metal stent was increased in patients with side by side method. Another study showed that there was no significant difference between those bilateral stent insertion methods. The most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial.

The purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD type) in patient with hilar malignant biliary obstruction.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction
  • older than 20 years old

Exclusion Criteria

  • Operable case
  • Non-hilar biliary malignant obstruction
  • Duodenal obstruction
  • Other cancer except biliary malignancy
  • uncontrolled infection status
  • Eastern Cooperative Oncology Group ≥ 3
  • No signed informed consent
  • Failed endoscopic approach to duodenum or biliary tract

Arms & Interventions

Side by side group

Experimental

Intervention: side by side (Procedure)

Stent in stent group

Active Comparator

Intervention: stent in stent (Procedure)

Outcomes

Primary Outcomes

Median patency duration

Time Frame: 1 year after stent insertion

Median patency duration from stent insertion date to stent occlusion date or last follow up date if stent is patent

Secondary Outcomes

  • Overall survival(1 year)
  • complication rate(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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