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

Bile Duct Obstruction Clinical Trial

Official title:

Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01125865
• Other study ID #: SCH-2010-04
• Status: Recruiting
• Phase: Phase 4
• First received: May 14, 2010
• Last updated: March 9, 2011
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2010
• Source: Soon Chun Hyang University
• Contact: Do Hyun Park, MD
• Phone: +82-2-3010-3180
• Email: dhpark[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Obstruction
• Cholestasis
• Klatskin's Tumor

Intervention

Device:
• SEMS insertion
Self-expandable metallic stent will be inserted for malignant hilar obstruction.
• DLS insertion
DoubleLayer plastic stent will be inserted for malignant hilar obstruction.

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Cheonan	23-20 Bongmyung-dong
Korea, Republic of	Eulji University Hospital	Daejeon	Seo-gu, Dunsan-dong
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan	Busanjin-gu, Gaegeum-dong
Korea, Republic of	Asan Medical Center	Seoul	Pungnap-2dong, Songpagu

Sponsors (1)

Lead Sponsor	Collaborator
Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent patency	Interval time (d) from stent insertion to occlusion	Up to 2 years	Yes
Secondary	All cause complications	Early or Late complications; asymptomatic hyperamylasemia; pancreatitis (mild/moderate/severe); cholecystitis; cholangitis; recurrent jaundice; Internal migration; external migration; occlusion	Up to 2 years	Yes
Secondary	Cost-effectiveness	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	Up to 2 years	Yes
Secondary	Mortality		Up to 2 years	Yes
Secondary	Technical success	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	within 24 hr after stent insertion	Yes