Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction

National Cancer Center (NCC)

Status and phase: Unknown; Phase 4

Conditions: Gastric Outlet Obstruction Due to Malignancy

Treatments: Device: DoubleBare stent; Procedure: placement of double bare stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02156505

NCCCTSMD12009

Details and patient eligibility

About

Self-expandable metallic stents provide effective palliation of malignant gastric outlet obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor in-growth through the stent mesh. The Self-expandable metallic stents which has the design of smaller wire mesh size (double bare stent) were developed and used in Korea. This new design was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The end point of this study is the 8-weeks patency rate after placement of double bare as well as technical and clinical success rates.

Enrollment: 49 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Malignant gastric outlet obstruction
• Symptoms compatible with gastric outlet obstruction
• An inoperable condition because of extent of disease or patient's conditions

Exclusion criteria

• History of enteral stent placement, undergone gastric surgery.
• Additional small bowel stenosis distal to gastric outlet obstruction.
• Refuse to be enrolled to study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

DoubleBare stent

Experimental group

Description:

Placement of double bare stent

Treatment:

Procedure: placement of double bare stent

Device: DoubleBare stent