Efficacy of a new Wallflex Duodenal Soft stent for palliation of gastric outlet obstruction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24271

Enrollment

Registered

2019-06-24

Start date

2019-05-28

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant gastric outlet obstruction

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Histologically proven malignant gastric outlet obstruction • Gastric Outlet Obstruction Scoring System (GOOSS) score of =2 • No curative treatment options available • Planned to undergo duodenal SEMS insertion • Life expectancy of less than 3 months • Age = 18 years • Written informed consent* *To collect data from the electronic patient system

Exclusion criteria

Exclusion criteria: • Previous SEMS insertion for the same condition • Patients with pre-procedural evidence of an additional more distally located stricture (i.e. small bowel or colon)

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of the WallFlex Duodenal Soft Stent in palliation of GOO-symptoms	—

Secondary

Measure	Time frame
Safety and overall functional outcomes, including WHO-performance score, days of admission both after stent placement and for (S)AE, quality of life and overall survival	—

Contacts

Public ContactRuben van der Bogt

Erasmus MC

r.vanderbogt@erasmusmc.nl+31650033985

Outcome results