Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

Study Overview
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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.

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.

Official Title
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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

Conditions
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Biliary Tract Neoplasms, Jaundice, Obstructive

Intervention / Treatment
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* Device: ComVi stent
* Device: Uncovered SEMS


Participation Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The stent patency | 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 | 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 | 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 |  | up to 53 months | 
| patient survival |  | up to 53 months | 
| adverse events | stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis | within 4 weeks since initial ERBD | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stents, Endoscopy, Cholangiopancreatography, Endoscopic Retrograde