Clinical trial · Interventional
Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction
Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Outlet Obstruction Due to Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DoubleBare stent | Device | — | UNRESOLVED |
| placement of double bare stent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DoubleBare stent
- description
- Placement of double bare stent
- interventionNames
- Procedure: placement of double bare stent
- Device: DoubleBare stent
Primary outcomes (1)
- measure
- The patency rate at 8 weeks after placement.
- timeFrame
- 8 weeks
Secondary outcomes (3)
- measure
- Technical and clinical success rates
- timeFrame
- up to 8 weeks
- measure
- re-stenosis rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available