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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

Tracking Information
First Submitted Date  ICMJE June 1, 2010
First Posted Date  ICMJE March 15, 2011
Last Update Posted Date April 21, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
The stent patency [ Time Frame: up to 53 months ]
period between stent insertion and stent occlusion or death of the patient
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2011)
Time to stent occlusion [ Time Frame: Upon SEMS occlusion, patient death, or end of the study period (average 1 year) ]
Change History Complete list of historical versions of study NCT01315522 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • 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
  • 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)
  • time-to-stent occlusion [ Time Frame: up to 53 months ]
  • patient survival [ Time Frame: up to 53 months ]
  • adverse events [ Time Frame: within 4 weeks since initial ERBD ]
    stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Biliary Tract Neoplasms
  • Jaundice, Obstructive
Intervention  ICMJE
  • Device: ComVi stent
    Endoscopic insertion of ComVi stent
  • Device: Uncovered SEMS
    Endoscopic insertion of uncovered SEMS
Study Arms  ICMJE
  • Active Comparator: ComVi stent
    ComVi stent (Niti-S stent, ComVi type, Taewoong Medical Inc, Korea)
    Intervention: Device: ComVi stent
  • Active Comparator: Uncovered SEMS
    uncovered nitinol metal stent (HANAROSTENT, M.I. Tech Co., Ltd., Korea)
    Intervention: Device: Uncovered SEMS
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2011)
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01315522
Other Study ID Numbers  ICMJE ERBD2SEMS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ji Kon Ryu, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ji Kon Ryu, MD, PhD Seoul National University Hospital, Seoul National University College of Medicine
PRS Account Seoul National University Hospital
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP