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Biliary Tract NeoplasmsPhase 4NCT01315522

Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

A Phase 4 study testing ComVi stent and Uncovered SEMS in people with Biliary Tract Neoplasms and Jaundice, Obstructive, run by Seoul National University Hospital at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
ComVi stent and Uncovered SEMS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
3 sitesSouth Korea
Study dates
Jun 2010to Apr 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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)
  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
ComVi stent, Uncovered SEMS
Keywords
Stents, Endoscopy, Cholangiopancreatography, Endoscopic Retrograde
Medical subject headings
Biliary Tract Neoplasms, Jaundice, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ComVi stentDevice

    Endoscopic insertion of ComVi stent

  • Uncovered SEMSDevice

    Endoscopic insertion of uncovered SEMS

Study groups in NCT01315522
Study groupRoleWhat they receive
ComVi stentActive comparatorComVi stent (Niti-S stent, ComVi type, Taewoong Medical Inc, Korea)
Receives: Device: ComVi stent
Uncovered SEMSActive comparatoruncovered nitinol metal stent (HANAROSTENT, M.I. Tech Co., Ltd., Korea)
Receives: Device: Uncovered SEMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The stent patency

    period between stent insertion and stent occlusion or death of the patient

    Measured: up to 53 months

Secondary outcomes (5)

  1. Technical success

    Technical success was achieved when the SEMS was placed across the stricture with appropriate radiographic positioning and immediate biliary decompression

    Measured: for the duration of ERCP procedure, an expected average of 30 minutes

  2. clinical success

    Clinical success was achieved in the case of ≥ 50% reduction or normalization of total bilirubin level (≤ 1.2 mg/dL)

    Measured: within 2 weeks since initial ERBD

  3. time-to-stent occlusion

    Measured: up to 53 months

  4. patient survival

    Measured: up to 53 months

  5. adverse events

    stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis

    Measured: within 4 weeks since initial ERBD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionNov 2014
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01315522
Sponsor's protocol ID
ERBD2SEMS
Status last verified
Apr 2015
First submitted
1 Jun 2010
Last updated
21 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Lee BS, Ryu JK, Jang DK, Chung KH, Yoon WJ, Kim J, Woo SM, Lee SH, Lee WJ, Kim YT. Reintervention for occluded metal stent in malignant bile duct obstruction: A prospective randomized trial comparing covered and uncovered metal stent. J Gastroenterol Hepatol. 2016 Nov;31(11):1901-1907. doi: 10.1111/jgh.13392.

    PubMed 27029890

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ComVi stent and Uncovered SEMS in people with Biliary Tract Neoplasms and Jaundice, Obstructive, run by Seoul National University Hospital at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The stent patency (time frame: up to 53 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01315522, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.

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