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  • Title: Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial.
    Author: Kastelijn JB, van de Pavert YL, Besselink MG, Fockens P, Voermans RP, van Wanrooij RLJ, de Wijkerslooth TR, Curvers WL, de Hingh IHJT, Bruno MJ, Koerkamp BG, Patijn GA, Poen AC, van Hooft JE, Inderson A, Mieog JSD, Poley JW, Bijlsma A, Lips DJ, Venneman NG, Verdonk RC, van Dullemen HM, Hoogwater FJH, Frederix GWJ, Molenaar IQ, Welsing PMJ, Moons LMG, van Santvoort HC, Vleggaar FP, Dutch Pancreatic Cancer Group.
    Journal: Trials; 2023 Sep 25; 24(1):608. PubMed ID: 37749590.
    Abstract:
    BACKGROUND: 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.
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