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  • 1
    In: Trials, Springer Science and Business Media LLC, Vol. 24, No. 1 ( 2023-09-25)
    Abstract: Malignant gastric outlet obstruction (GOO) is a debilitating condition that frequently occurs in patients with malignancies of the distal stomach and (peri)ampullary region. The standard palliative treatment for patients with a reasonable life expectancy and adequate performance status is a laparoscopic surgical gastrojejunostomy (SGJ). Recently, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) emerged as a promising alternative to the surgical approach. The present study aims to compare these treatment modalities in terms of efficacy, safety, and costs. Methods The ENDURO-study is a multicentre, open-label, parallel-group randomized controlled trial. In total, ninety-six patients with gastric outlet obstruction caused by an irresectable or metastasized malignancy will be 1:1 randomized to either SGJ or EUS-GE. The primary endpoint is time to tolerate at least soft solids. The co-primary endpoint is the proportion of patients with persisting or recurring symptoms of gastric outlet obstruction for which a reintervention is required. Secondary endpoints are technical and clinical success, quality of life, gastroenterostomy dysfunction, reinterventions, time to reintervention, adverse events, quality of life, time to start chemotherapy, length of hospital stay, readmissions, weight, survival, and costs. Discussion The ENDURO-study assesses whether EUS-GE, as compared to SGJ, results in a faster resumption of solid oral intake and is non-inferior regarding reinterventions for persistent or recurrent obstructive symptoms in patients with malignant GOO. This trial aims to guide future treatment strategies and to improve quality of life in a palliative setting. Trial registration International Clinical Trials Registry Platform (ICTRP): NL9592. Registered on 07 July 2021.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2040523-6
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  • 2
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2023
    In:  Current Treatment Options in Gastroenterology
    In: Current Treatment Options in Gastroenterology, Springer Science and Business Media LLC
    Abstract: Gastric outlet obstruction is a syndrome that is caused by several benign and malignant diseases. Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is a novel treatment that seems to combine the advantages of the two traditional treatments: enteral stent placement (ES) and surgical gastrojejunostomy (SGJ). This review aims to determine the current position of EUS-GE amidst the two traditional treatment options. Recent findings Different approaches can be adopted to facilitate EUS-GE. Direct gastroenterostomy seems to have the shortest procedure time. All methods possess high technical success rates. Several retrospective analyses have compared EUS-GE to ES and SGJ. EUS-GE seems to have better stent patency compared to ES and a lower adverse event rate compared to SGJ. Recently, randomized trials have been initiated which compare EUS-GE with ES or SGJ. Summary Although the currently published literature unequivocally shows the great promises of EUS-GE, properly powered and controlled studies are warranted to ascertain the definitive position of EUS-GE within the treatment repertoire of GOO. Until reliable data has been collected, EUS-GE can be considered a safe and effective alternative to ES and SGJ.
    Type of Medium: Online Resource
    ISSN: 1534-309X
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2090729-1
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