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

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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:

Tringali A, Mutignani M, Perri V, Zuccalà G, Cipolletta L, Bianco MA, Rotondano G, Philipper M, Schumacher B, Neuhaus H, Schmit A, Devière 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.

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.

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. Review. No abstract available.

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.

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.

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.

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.

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.

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 May 23, 2013