Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

April 20, 2015 updated by: Ji Kon Ryu, Seoul National University Hospital

Re-intervention for Occluded Biliary Metal Stent in Malignant Distal Bile Duct Obstruction: a Prospective Randomized Multi-center Trial Comparing Covered and Uncovered Metal Stent

Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard intervention for the relief of obstructive jaundice in patients with unresectable malignant biliary obstruction. Although plastic stents (PSs) were developed earlier, self-expandable metal stents (SEMSs) are now used widely as the initial choice for ERBD in this setting, as SEMSs offer longer patency.However, SEMSs do become occluded in some patients. There are a limited number of reports on the management of occluded SEMS with various results. The aim of this study is to compare the efficacy of ComVi stents SEMSs with uncovered SEMS in subsequent ERBD after the occlusion of initial SEMSs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endoscopic placement of self-expandable metallic stents (SEMSs) is the mainstay of palliative measures for alleviating obstructive jaundice secondary to advanced cholangiocarcinoma. Previous meta-analysis showed no significant difference in stent patency between covered and uncovered SEMS, which are currently available. However, information on secondary SEMS insertion is still scarce, and there has been no prospective trial comparing efficacy of secondary stenting between covered and uncovered SEMS for the management of occluded metal stent in malignant biliary obstruction. Previously, only two small retrospective studies addressed this issue. Given the absence of prospective trial on re-intervention for occluded SEMS in malignant biliary obstruction, we aimed to prospectively compare the efficacies and complication rates of secondary ComVi stent (cSEMS) and uSEMS for the management of such condition.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with SEMS occlusion, which was inserted either endoscopically or percutaneously, for the relief of malignant nonhilar biliary obstruction
  • Patients in whom the above SEMS had been inserted for no less than 7 days

  • Patients with one of the following:

    1. cholangitis (as defined by fever, tenderness in the right upper quadrant or epigastrium, and/or a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion)
    2. a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion
  • Patients in whom the cause of initial ERBD occlusion was identified, such as tumor overgrowth, ingrowth, and/or sludge
  • Age ≥ 20 years

Exclusion Criteria:

  • Unable to give informed consent
  • Patients with sepsis and/or shock not responding to medical treatment or Eastern Cooperative Oncology Group (ECOG) Performance Status 4
  • Patients with estimated survival < 4 weeks
  • Patients who had undergone curative or palliative surgical intervention
  • Hilar or perihilar biliary obstruction
  • Patients who had undergone endoscopic nasobiliary drainage,plastic stent insertion, or percutaneous transhepatic biliary drainage prior to second SEMS insertion
  • Covered SEMS as initial SEMS
  • Migration or food impaction as the cause of initial SEMS occlusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ComVi stent
ComVi stent (Niti-S stent, ComVi type, Taewoong Medical Inc, Korea)
Device: ComVi stent
Endoscopic insertion of ComVi stent
ACTIVE_COMPARATOR: Uncovered SEMS
uncovered nitinol metal stent (HANAROSTENT, M.I. Tech Co., Ltd., Korea)
Device: Uncovered SEMS
Endoscopic insertion of uncovered SEMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The stent patency
Time Frame: up to 53 months
period between stent insertion and stent occlusion or death of the patient
up to 53 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: for the duration of ERCP procedure, an expected average of 30 minutes
Technical success was achieved when the SEMS was placed across the stricture with appropriate radiographic positioning and immediate biliary decompression
for the duration of ERCP procedure, an expected average of 30 minutes
clinical success
Time Frame: within 2 weeks since initial ERBD
Clinical success was achieved in the case of ≥ 50% reduction or normalization of total bilirubin level (≤ 1.2 mg/dL)
within 2 weeks since initial ERBD
time-to-stent occlusion
Time Frame: up to 53 months
up to 53 months
patient survival
Time Frame: up to 53 months
up to 53 months
adverse events
Time Frame: within 4 weeks since initial ERBD
stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis
within 4 weeks since initial ERBD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ji Kon Ryu, MD, PhD, Seoul National University Hospital, Seoul National University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

March 13, 2011

First Posted (ESTIMATE)

March 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERBD2SEMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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