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

Soon Chun Hyang University

Status and phase: Unknown; Phase 4

Conditions: Klatskin's Tumor; Bile Duct Obstruction

Treatments: Device: DLS insertion; Device: SEMS insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT01125865

SCH-2010-04

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

SEMS

Active Comparator group

Description:

Self-expandable metallic stent will be inserted for the malignant hilar obstruction.

Treatment:

Device: SEMS insertion

DLS

Active Comparator group

Description:

DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.

Treatment:

Device: DLS insertion