TY - JOUR
T1 - Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO)
T2 - study protocol for a randomized controlled trial
AU - Dutch Pancreatic Cancer Group
AU - Kastelijn, Janine B.
AU - van de Pavert, Yorick L.
AU - Besselink, Marc G.
AU - Fockens, Paul
AU - Voermans, Rogier P.
AU - van Wanrooij, Roy L.J.
AU - de Wijkerslooth, Thomas R.
AU - Curvers, Wouter L.
AU - de Hingh, Ignace H.J.T.
AU - Bruno, Marco J.
AU - Koerkamp, Bas Groot
AU - Patijn, Gijs A.
AU - Poen, Alexander C.
AU - van Hooft, Jeanin E.
AU - Inderson, Akin
AU - Mieog, J. Sven D.
AU - Poley, Jan Werner
AU - Bijlsma, Alderina
AU - Lips, Daan J.
AU - Venneman, Niels G.
AU - Verdonk, Robert C.
AU - van Dullemen, Hendrik M.
AU - Hoogwater, Frederik J.H.
AU - Frederix, Geert W.J.
AU - Molenaar, I. Quintus
AU - Welsing, Paco M.J.
AU - Moons, Leon M.G.
AU - van Santvoort, Hjalmar C.
AU - Vleggaar, Frank P.
N1 - Publisher Copyright:
© 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Endoscopic ultrasonography
KW - Gastric outlet obstruction
KW - Gastroenterostomy
KW - Gastrojejunostomy
KW - Malignancy
KW - Surgery
UR - http://www.scopus.com/inward/record.url?scp=85172179296&partnerID=8YFLogxK
U2 - 10.1186/s13063-023-07522-7
DO - 10.1186/s13063-023-07522-7
M3 - Article
C2 - 37749590
AN - SCOPUS:85172179296
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
M1 - 608
ER -