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CompletedNCT01421836Updated Apr 28, 2016

Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction

A Phase 2/3 interventional study of ERCP-guided stent insertion and EUS guided stent insertion in Tumor Appearance of Biliary System Obstruction, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-28.

Sponsored by Samsung Medical Center · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

  1. Purpose of the study

    -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction

  2. Subjects of the study

    -Patients who have biliary obstruction owing to malignant tumors

  3. Methods of the study

    • Prospective randomized controlled study
    • Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group
    • Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction
    • After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.
Read the detailed description
  1. Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study
  2. Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT > 1.5 INR, PLT \< 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction
02

Conditions studied

  • Tumor Appearance of Biliary System Obstruction

Keywords

  • stent patency
  • EUS guided insertion
  • ERCP guided insertion
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • distal biliary obstruction due to malignant tumor
  • unresectable tumor
  • Jaundice

Exclusion criteria

Exclusion Criteria:

  • Children
  • Hilar obstruction
  • Active infection
  • Bleeding tendency
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    ERCP guided stent insertion

    Procedure: ERCP-guided stent insertion

  • Active comparator
    EUS guided stent insertion

    Procedure: EUS guided stent insertion

Interventions

  • ProcedureERCP-guided stent insertion

    ERCP guided stent insertion for malignant biliary obstruction

    Also known as: ERCP-guided metal stent insertion

  • ProcedureEUS guided stent insertion

    EUS-guided stent insertion for malignant biliary obstruction

    Also known as: EUS-guided metal stent insertion

06

What researchers measure

Primary outcomes

  1. stent patency (days)

    Time frame: six months

Secondary outcomes

  1. complication rate

    Time frame: six months

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Irwon-dong, Gangnam-gu 135-710, Korea, Republic of
08

References and documents

Publications

  • Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30. PubMed 29605722 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01421836
Lead sponsor
Samsung Medical Center
Responsible party
Kwang Hyuck Lee (Professor of Department of Medicine,Samsung Medical Center,Sungkyunkwan University School of Medicine, Samsung Medical Center) — Principal investigator
First posted
Aug 23, 2011
Start date
May 2011
Primary completion
Oct 2015
Completion
Mar 2016
Last update
Apr 28, 2016

Study contacts

Kwanghyuck Lee, MD, phD
study director · Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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