Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01125865|
Recruitment Status : Unknown
Verified May 2010 by Soon Chun Hyang University.
Recruitment status was: Recruiting
First Posted : May 19, 2010
Last Update Posted : March 10, 2011
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 or disease||Intervention/treatment||Phase|
|Bile Duct Obstruction Klatskin's Tumor||Device: SEMS insertion Device: DLS insertion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||December 2011|
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.
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
- Stent patency [ Time Frame: Up to 2 years ]Interval time (d) from stent insertion to occlusion
- All cause complications [ Time Frame: Up to 2 years ]
Early or Late complications
- asymptomatic hyperamylasemia
- pancreatitis (mild/moderate/severe)
- recurrent jaundice
- Internal migration
- external migration
- Cost-effectiveness [ Time Frame: Up to 2 years ]
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 ]
- Technical success [ Time Frame: within 24 hr after stent insertion ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125865
|Contact: Do Hyun Park, MDfirstname.lastname@example.org|
|Contact: Tae Hoon Lee, MDemail@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Asan Medical Center||Recruiting|
|Seoul, Pungnap-2dong, Songpagu, Korea, Republic of, 388-1|
|Contact: Do Hyun Park, MD +82-2-3010-3180 firstname.lastname@example.org|
|Eulji University Hospital||Recruiting|
|Daejeon, Seo-gu, Dunsan-dong, Korea, Republic of, 302-799|
|Contact: Sang Woo Cha, MD +82-42-611-3052 email@example.com|