Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ji Kon Ryu, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01315522
First received: June 1, 2010
Last updated: April 20, 2015
Last verified: April 2015
  Purpose

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 Intervention Phase
Biliary Tract Neoplasms
Jaundice, Obstructive
Device: ComVi stent
Device: Uncovered SEMS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The stent patency [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]
    period between stent insertion and stent occlusion or death of the patient


Secondary Outcome Measures:
  • Technical success [ Time Frame: for the duration of ERCP procedure, an expected average of 30 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • patient survival [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: within 4 weeks since initial ERBD ] [ Designated as safety issue: Yes ]
    stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis


Enrollment: 43
Study Start Date: June 2010
Study Completion Date: April 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315522

Locations
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
Investigators
Principal Investigator: Ji Kon Ryu, MD, PhD Seoul National University Hospital, Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Ji Kon Ryu, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01315522     History of Changes
Other Study ID Numbers: ERBD2SEMS
Study First Received: June 1, 2010
Last Updated: April 20, 2015
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Stents
Endoscopy
Cholangiopancreatography
Endoscopic Retrograde

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Jaundice, Obstructive
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Hyperbilirubinemia
Jaundice
Neoplasms
Neoplasms by Site
Pathologic Processes
Signs and Symptoms
Skin Manifestations

ClinicalTrials.gov processed this record on April 23, 2015