Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Biliary Tract Neoplasms Jaundice, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ComVi stent

ComVi stent (Niti-S stent, ComVi type, Taewoong Medical Inc, Korea)

Group Type ACTIVE_COMPARATOR

ComVi stent

Intervention Type DEVICE

Endoscopic insertion of ComVi stent

Uncovered SEMS

uncovered nitinol metal stent (HANAROSTENT, M.I. Tech Co., Ltd., Korea)

Group Type ACTIVE_COMPARATOR

Uncovered SEMS

Intervention Type DEVICE

Endoscopic insertion of uncovered SEMS

Interventions

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ComVi stent

Endoscopic insertion of ComVi stent

Intervention Type DEVICE

Uncovered SEMS

Endoscopic insertion of uncovered SEMS

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No