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

Phase 4

• Conditions: Bile Duct Obstruction; Klatskin's Tumor
• Interventions: Device: DLS insertion; Device: SEMS insertion

• Registration Number: NCT01125865
• Lead Sponsor: Soon Chun Hyang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted: 2010-05-14
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Last Update Submitted: 2011-03-09
• Last Update Posted: 2011-03-10
• Primary Completion: 2011-07
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DLS	DLS insertion	DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.
SEMS	SEMS insertion	Self-expandable metallic stent will be inserted for the malignant hilar obstruction.

Primary Outcome Measures

Name	Time	Method
Stent patency	Up to 2 years	Interval time (d) from stent insertion to occlusion

Secondary Outcome Measures

Name	Time	Method
All cause complications	Up to 2 years	Early or Late complications; * asymptomatic hyperamylasemia; * pancreatitis (mild/moderate/severe); * cholecystitis; * cholangitis; * recurrent jaundice; * Internal migration; * external migration; * occlusion
Cost-effectiveness	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	Up to 2 years
Technical success	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

Trial Locations

Locations (4)

Soon Chun Hyang University Cheonan Hospital; 🇰🇷 Cheonan, 23-20 Bongmyung-dong, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Pungnap-2dong, Songpagu, Korea, Republic of

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, Busanjin-gu, Gaegeum-dong, Korea, Republic of

Eulji University Hospital; 🇰🇷 Daejeon, Seo-gu, Dunsan-dong, Korea, Republic of