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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEMS | Active Comparator | Self-expandable metallic stent will be inserted for the malignant hilar obstruction. |
|
| DLS | Active Comparator | DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEMS insertion | Device | Self-expandable metallic stent will be inserted for malignant hilar obstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stent patency | Interval time (d) from stent insertion to occlusion | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| All cause complications | Early or Late complications
| Up to 2 years |
| Cost-effectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Do Hyun Park, MD | Contact | +82-2-3010-3180 | dhpark@amc.seoul.kr | |
| Tae Hoon Lee, MD | Contact | +82-41-570-3662 | thlee9@lycos.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Cheonan Hospital | Recruiting | Cheonan | 23-20 Bongmyung-dong | 330-721 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14648409 | Background | 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. | |
| 7686100 |
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| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D018285 | Klatskin Tumor |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D018281 | Cholangiocarcinoma |
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| DLS insertion | Device | DoubleLayer plastic stent will be inserted for malignant hilar obstruction. |
|
|
Total Cost for SEMS and DLS group
|
| Up to 2 years |
| Mortality | Up to 2 years |
| Technical success |
| within 24 hr after stent insertion |
| Inje University Pusan Paik Hospital | Recruiting | Pusan | Busanjin-gu, Gaegeum-dong | 614-735 | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | Pungnap-2dong, Songpagu | 388-1 | South Korea |
|
| Eulji University Hospital | Recruiting | Daejeon | Seo-gu, Dunsan-dong | 302-799 | South Korea |
|
| 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. |
| 10536130 | Background | 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. |
| 10202060 | Background | 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. |
| 9609426 | Background | 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. |
| 1281903 | Background | 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. |
| 9468416 | Background | 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. |
| 12085032 | Background | 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. |
| D000230 |
| Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |