No registrations found.
ID
Source
Brief title
Health condition
Malignant gastric outlet obstruction
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the efficacy of the WallFlex Duodenal Soft Stent in palliation of GOO-symptoms
Secondary outcome
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
Background summary
Rationale: Malignant gastric outlet obstruction (GOO) is a late complication of advanced gastric and periampullary malignancies. Self-expandable metallic stent (SEMS) insertion is recommended for palliation of GOO-symptoms in patients with a life-expectancy of less than 2 months. Recently, Boston Scientific released a new duodenal SEMS which has a higher flexibility than previously released SEMS. It is believed that this higher flexibility provides a potential benefit in case of severe strictures or anatomic difficulties. Until now, no data are available on the efficacy of this new SEMS design.
Objective: To evaluate the efficacy of the new WallFlex Duodenal Soft Stent in palliation of GOO-symptoms.
Study design: Prospective, single-center, observational cohort study
Study population: Patients who will undergo treatment of GOO-symptoms in the Erasmus University Medical Center.
Intervention: The WallFlex Duodenal Soft Stent will be used, manufactured by Boston Scientific (Marlborough, USA).
Main study parameters/endpoints: Primary objective of this study will be to assess the efficacy of the WallFlex Duodenal Soft Stent in palliation of gastric outlet symptoms. This will be assessed using the clinical success rate at 2 weeks. Clinical success will be defined as an improvement of the Gastric Outlet Obstruction Scoring System (GOOSS) score to ≥2 (i.e. able to consume soft solids).
Study objective
It is believed that the higher flexibility of the Wallflex Duodenal Soft stent provides a potential benefit in case of severe strictures or anatomic difficulties.
Study design
MEC approval has been granted
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
• 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7822 |
| Other | METC Erasmus MC : MEC-2019-0251 |