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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bile Duct Obstruction; Klatskin's Tumor
• Intervention / Treatment: Device: SEMS insertion; Device: DLS insertion

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Do Hyun Park, MD; Phone Number: +82-2-3010-3180; Email: dhpark@amc.seoul.kr

Study Locations

• Korea, Republic of
  • 23-20 Bongmyung-dong
    • Cheonan, 23-20 Bongmyung-dong, Korea, Republic of, 330-721
      • Recruiting
      • Soon Chun Hyang University Cheonan Hospital
  • Busanjin-gu, Gaegeum-dong
    • Pusan, Busanjin-gu, Gaegeum-dong, Korea, Republic of, 614-735
      • Recruiting
      • Inje University Pusan Paik Hospital
      • Contact: Jung Sik Choi, MD; Phone Number: +82-51-890-6114; Email: cwj1225@medigate.net
  • Pungnap-2dong, Songpagu
    • Seoul, Pungnap-2dong, Songpagu, Korea, Republic of, 388-1
      • Recruiting
      • Asan Medical Center
      • Contact: Do Hyun Park, MD; Phone Number: +82-2-3010-3180; Email: dhpark@amc.seoul.kr
  • Seo-gu, Dunsan-dong
    • Daejeon, Seo-gu, Dunsan-dong, Korea, Republic of, 302-799
      • Recruiting
      • Eulji University Hospital
      • Contact: Sang Woo Cha, MD; Phone Number: +82-42-611-3052; Email: swcha@eulji.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Olympus DoubleLayer stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent patency	Interval time (d) from stent insertion to occlusion	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Mortality		Up to 2 years
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

Collaborators and Investigators

• Sponsor: Soon Chun Hyang University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ANTICIPATED): July 1, 2011
• Study Completion (ANTICIPATED): December 1, 2011

Study Registration Dates

• First Submitted: May 14, 2010
• First Submitted That Met QC Criteria: May 18, 2010
• First Posted (ESTIMATE): May 19, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 10, 2011
• Last Update Submitted That Met QC Criteria: March 9, 2011
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Malignant hilar stricture
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Cholangiocarcinoma; Constriction, Pathologic; Klatskin Tumor; Cholestasis
• Other Study ID Numbers: SCH-2010-04