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.
ID
Bron
Verkorte titel
Aandoening
Malignant gastric outlet obstruction
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To assess the efficacy of the WallFlex Duodenal Soft Stent in palliation of GOO-symptoms
Achtergrond van het onderzoek
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).
Doel van het onderzoek
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.
Onderzoeksopzet
MEC approval has been granted
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7822 |
| Ander register | METC Erasmus MC : MEC-2019-0251 |