ComVi Stent Versus Uncovered Self-Expandable Metal Stent (SEMS) for Biliary SEMS Occlusion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ji Kon Ryu, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01315522
First received: June 1, 2010
Last updated: September 19, 2012
Last verified: September 2012
  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: Subsequent ERBD After Occlusion of Metal Biliary Stent in Patients With Unresectable Malignant Biliary Obstruction - Comparison of ComVi Stent Versus Uncovered Metal Stents

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Time to stent occlusion [ Time Frame: Upon SEMS occlusion, patient death, or end of the study period (average 1 year) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ComVi stent Device: ComVi stent
Endoscopic insertion of ComVi stent
Active Comparator: Uncovered SEMS Device: Uncovered SEMS
Endoscopic insertion of uncovered SEMS

  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

Contacts
Contact: Ji Kon Ryu, MD, PhD +82-2-2072-1962 jkryu@snu.ac.kr
Contact: Won Jae Yoon, MD +82-2-2072-3025 biliary@naver.com

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Woo Jin Lee, MD, PhD       lwj@ncc.re.kr   
Contact: Sang Myung Woo, MD       yawookim@yahoo.co.kr   
Principal Investigator: Woo Jin Lee, MD, PhD         
Sub-Investigator: Sang Myung Woo, MD, PhD         
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jin-Hyeok Hwang, MD, PhD       woltoong@dreamwiz.com   
Contact: Sang Hyub Lee, MD, PhD       shlee913@hanmail.net   
Principal Investigator: Jin-Hyeok Hwang, MD, PhD         
Sub-Investigator: Sang Hyub Lee, MD, PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Ji Kon Ryu, MD, PhD    +82-2-2072-1962    jkryu@snu.ac.kr   
Contact: Won Jae Yoon, MD    +82-2-2072-3025    biliary@naver.com   
Principal Investigator: Ji Kon Ryu, MD, PhD         
Sub-Investigator: Won Jae Yoon, MD         
Sub-Investigator: Yong-Tae Kim, MD, PhD         
Sub-Investigator: Yong Bum Yoon, MD, PhD         
Sub-Investigator: Woo Hyun Paik, MD         
Sub-Investigator: Byeong Jun Song, MD         
Sub-Investigator: Jin Myung Park, MD         
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: September 19, 2012
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014