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Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01315522
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : April 21, 2015
Information provided by (Responsible Party):
Ji Kon Ryu, Seoul National University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Biliary Tract Neoplasms Jaundice, Obstructive Device: ComVi stent Device: Uncovered SEMS Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : June 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : April 2015

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

Primary Outcome Measures :
  1. The stent patency [ Time Frame: up to 53 months ]
    period between stent insertion and stent occlusion or death of the patient

Secondary Outcome Measures :
  1. 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

  2. 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)

  3. time-to-stent occlusion [ Time Frame: up to 53 months ]
  4. patient survival [ Time Frame: up to 53 months ]
  5. adverse events [ Time Frame: within 4 weeks since initial ERBD ]
    stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01315522

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Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Ji Kon Ryu, MD, PhD Seoul National University Hospital, Seoul National University College of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ji Kon Ryu, Professor, Seoul National University Hospital Identifier: NCT01315522     History of Changes
Other Study ID Numbers: ERBD2SEMS
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Keywords provided by Ji Kon Ryu, Seoul National University Hospital:
Endoscopic Retrograde
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Jaundice, Obstructive
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases