NCT01125865

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2010

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 10, 2011

Status Verified

May 1, 2010

Enrollment Period

1.2 years

First QC Date

May 14, 2010

Last Update Submit

March 9, 2011

Conditions

Bile Duct ObstructionKlatskin's Tumor

Keywords

Malignant hilar stricture

Outcome Measures

Primary Outcomes (1)

  • Stent patency

    Interval time (d) from stent insertion to occlusion

    Up to 2 years

Secondary Outcomes (4)

  • All cause complications

    Up to 2 years

  • Cost-effectiveness

    Up to 2 years

  • Mortality

    Up to 2 years

  • Technical success

    within 24 hr after stent insertion

Study Arms (2)

SEMS

ACTIVE COMPARATOR

Self-expandable metallic stent will be inserted for the malignant hilar obstruction.

Device: SEMS insertion

DLS

ACTIVE COMPARATOR

DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.

Device: DLS insertion

Interventions

SEMS insertionDEVICE

Self-expandable metallic stent will be inserted for malignant hilar obstruction.

Also known as: Bona stent, TaeWoong stent
SEMS
DLS insertionDEVICE

DoubleLayer plastic stent will be inserted for malignant hilar obstruction.

Also known as: Olympus DoubleLayer stent
DLS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Soon Chun Hyang University Cheonan Hospital

Cheonan, 23-20 Bongmyung-dong, 330-721, South Korea

RECRUITING

Inje University Pusan Paik Hospital

Pusan, Busanjin-gu, Gaegeum-dong, 614-735, South Korea

RECRUITING

Asan Medical Center

Seoul, Pungnap-2dong, Songpagu, 388-1, South Korea

RECRUITING

Eulji University Hospital

Daejeon, Seo-gu, Dunsan-dong, 302-799, South Korea

RECRUITING

Related Publications (8)

  • Tringali A, Mutignani M, Perri V, Zuccala G, Cipolletta L, Bianco MA, Rotondano G, Philipper M, Schumacher B, Neuhaus H, Schmit A, Deviere J, Costamagna G. A prospective, randomized multicenter trial comparing DoubleLayer and polyethylene stents for malignant distal common bile duct strictures. Endoscopy. 2003 Dec;35(12):992-7. doi: 10.1055/s-2003-44601.

    PMID: 14648409BACKGROUND

  • Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy. 1993 Mar;25(3):213-8. doi: 10.1055/s-2007-1010295.

    PMID: 7686100BACKGROUND

  • de Groen PC, Gores GJ, LaRusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med. 1999 Oct 28;341(18):1368-78. doi: 10.1056/NEJM199910283411807. No abstract available.

    PMID: 10536130BACKGROUND

  • Yeoh KG, Zimmerman MJ, Cunningham JT, Cotton PB. Comparative costs of metal versus plastic biliary stent strategies for malignant obstructive jaundice by decision analysis. Gastrointest Endosc. 1999 Apr;49(4 Pt 1):466-71. doi: 10.1016/s0016-5107(99)70044-1.

    PMID: 10202060BACKGROUND

  • Chang WH, Kortan P, Haber GB. Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage. Gastrointest Endosc. 1998 May;47(5):354-62. doi: 10.1016/s0016-5107(98)70218-4.

    PMID: 9609426BACKGROUND

  • Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992 Dec 19-26;340(8834-8835):1488-92. doi: 10.1016/0140-6736(92)92752-2.

    PMID: 1281903BACKGROUND

  • Prat F, Chapat O, Ducot B, Ponchon T, Pelletier G, Fritsch J, Choury AD, Buffet C. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc. 1998 Jan;47(1):1-7. doi: 10.1016/s0016-5107(98)70291-3.

    PMID: 9468416BACKGROUND

  • Cheng JL, Bruno MJ, Bergman JJ, Rauws EA, Tytgat GN, Huibregtse K. Endoscopic palliation of patients with biliary obstruction caused by nonresectable hilar cholangiocarcinoma: efficacy of self-expandable metallic Wallstents. Gastrointest Endosc. 2002 Jul;56(1):33-9. doi: 10.1067/mge.2002.125364.

    PMID: 12085032BACKGROUND

MeSH Terms

Conditions

CholestasisKlatskin Tumor

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Do Hyun Park, MD

CONTACT

+82-2-3010-3180dhpark@amc.seoul.kr

Tae Hoon Lee, MD

CONTACT

+82-41-570-3662thlee9@lycos.co.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2010

First Posted

May 19, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2011

Study Completion

December 1, 2011

Last Updated

March 10, 2011

Record last verified: 2010-05

Locations

KR(4)