Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Soon Chun Hyang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Soon Chun Hyang University
ClinicalTrials.gov Identifier:
NCT01125865
First received: May 14, 2010
Last updated: March 9, 2011
Last verified: May 2010
  Purpose

The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months.

There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction.

The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.


Condition Intervention Phase
Bile Duct Obstruction
Klatskin's Tumor
Device: SEMS insertion
Device: DLS insertion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • Stent patency [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Interval time (d) from stent insertion to occlusion


Secondary Outcome Measures:
  • All cause complications [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

    Early or Late complications

    • asymptomatic hyperamylasemia
    • pancreatitis (mild/moderate/severe)
    • cholecystitis
    • cholangitis
    • recurrent jaundice
    • Internal migration
    • external migration
    • occlusion

  • Cost-effectiveness [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

    Total Cost for SEMS and DLS group

    • ERCP cost
    • Total ERBD cost (DLS or metal)
    • Total hospitalization cost
    • Cost for session x No. of session
    • Total (DLS vs. metal)cost /session

  • Mortality [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Technical success [ Time Frame: within 24 hr after stent insertion ] [ Designated as safety issue: Yes ]
    • Successful insertion of bilateral or unilateral stent insertion.
    • Time to adequate expansion (70% of maximal expanded diameter was dilated state) in metal stent ≤ 24 hrs
    • No stent migration within 24 hrs


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SEMS
Self-expandable metallic stent will be inserted for the malignant hilar obstruction.
Device: SEMS insertion
Self-expandable metallic stent will be inserted for malignant hilar obstruction.
Other Names:
  • Bona stent
  • TaeWoong stent
Active Comparator: DLS
DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.
Device: DLS insertion
DoubleLayer plastic stent will be inserted for malignant hilar obstruction.
Other Name: Olympus DoubleLayer stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient over 18 years old
  • Patient with malignant hilar obstruction

Exclusion Criteria:

  • No written informed consent
  • Patient with uncorrectable severe coagulopathy
  • Indication for surgical operation
  • Karnofsky score < 60%
  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: NCT01125865

Contacts
Contact: Do Hyun Park, MD +82-2-3010-3180 dhpark@amc.seoul.kr
Contact: Tae Hoon Lee, MD +82-41-570-3662 thlee9@lycos.co.kr

Locations
Korea, Republic of
Soon Chun Hyang University Cheonan Hospital Recruiting
Cheonan, 23-20 Bongmyung-dong, Korea, Republic of, 330-721
Contact: Tae Hoon Lee, MD    +82-41-570-3662    thlee9@lycos.co.kr   
Inje University Pusan Paik Hospital Recruiting
Pusan, Busanjin-gu, Gaegeum-dong, Korea, Republic of, 614-735
Contact: Jung Sik Choi, MD    +82-51-890-6114    cwj1225@medigate.net   
Asan Medical Center Recruiting
Seoul, Pungnap-2dong, Songpagu, Korea, Republic of, 388-1
Contact: Do Hyun Park, MD    +82-2-3010-3180    dhpark@amc.seoul.kr   
Eulji University Hospital Recruiting
Daejeon, Seo-gu, Dunsan-dong, Korea, Republic of, 302-799
Contact: Sang Woo Cha, MD    +82-42-611-3052    swcha@eulji.ac.kr   
Sponsors and Collaborators
Soon Chun Hyang University
  More Information

Publications:

Responsible Party: Tae Hoon Lee, Soon Chun Hyang University Cheonan Hospital
ClinicalTrials.gov Identifier: NCT01125865     History of Changes
Other Study ID Numbers: SCH-2010-04
Study First Received: May 14, 2010
Last Updated: March 9, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Soon Chun Hyang University:
Malignant hilar stricture

Additional relevant MeSH terms:
Cholestasis
Klatskin's Tumor
Constriction, Pathologic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014