Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial
Janine B. Kastelijn,
Yorick L. van de Pavert,
Marc G. Besselink,
Paul Fockens,
Rogier P. Voermans,
Roy L. J. van Wanrooij,
Thomas R. de Wijkerslooth,
Wouter L. Curvers,
Ignace H. J. T. de Hingh,
Marco J. Bruno,
Bas Groot Koerkamp,
Gijs A. Patijn,
Alexander C. Poen,
Jeanin E. van Hooft,
Akin Inderson,
J. Sven D. Mieog,
Jan-Werner Poley,
Alderina Bijlsma,
Daan J. Lips,
Niels G. Venneman,
Robert C. Verdonk,
Hendrik M. van Dullemen,
Frederik J. H. Hoogwater,
Geert W. J. Frederix,
I. Quintus Molenaar,
Paco M. J. Welsing,
Leon M. G. Moons,
Hjalmar C. van Santvoort,
Frank P. Vleggaar,
for the Dutch Pancreatic Cancer Group
Affiliations
Janine B. Kastelijn
Department of Gastroenterology and Hepatology, University Medical Center Utrecht
Yorick L. van de Pavert
Department of Gastroenterology and Hepatology, University Medical Center Utrecht
Marc G. Besselink
Department of Surgery, Amsterdam UMC, Location University of Amsterdam
Paul Fockens
Cancer Center Amsterdam
Rogier P. Voermans
Cancer Center Amsterdam
Roy L. J. van Wanrooij
Cancer Center Amsterdam
Thomas R. de Wijkerslooth
Department of Gastrointestinal Oncology, Netherlands Cancer Institute
Wouter L. Curvers
Department of Gastroenterology and Hepatology, Catharina Hospital
Ignace H. J. T. de Hingh
Department of Surgery, Catharina Hospital
Marco J. Bruno
Department of Gastroenterology and Hepatology, Erasmus University Medical Center
Bas Groot Koerkamp
Department of Surgery, Erasmus University Medical Center Cancer Institute
Gijs A. Patijn
Department of Surgery, Isala Clinics
Alexander C. Poen
Department of Gastroenterology and Hepatology, Isala Clinics
Jeanin E. van Hooft
Department of Gastroenterology and Hepatology, Leiden University Medical Center
Akin Inderson
Department of Gastroenterology and Hepatology, Leiden University Medical Center
J. Sven D. Mieog
Department of Surgery, Leiden University Medical Center
Jan-Werner Poley
Department of Gastroenterology and Hepatology, Maastricht University Medical Center+
Alderina Bijlsma
Department of Gastroenterology and Hepatology, Martini Hospital
Daan J. Lips
Department of Surgery, Medisch Spectrum Twente
Niels G. Venneman
Department of Gastroenterology and Hepatology, Medisch Spectrum Twente
Robert C. Verdonk
Department of Gastroenterology and Hepatology, St. Antonius Hospital
Hendrik M. van Dullemen
Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen
Frederik J. H. Hoogwater
Department of Surgery, University Medical Center Groningen, University of Groningen
Geert W. J. Frederix
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
I. Quintus Molenaar
Department of Surgery, St. Antonius Hospital
Paco M. J. Welsing
Division of Internal Medicine and Dermatology, University Medical Center Utrecht
Leon M. G. Moons
Department of Gastroenterology and Hepatology, University Medical Center Utrecht
Hjalmar C. van Santvoort
Department of Surgery, St. Antonius Hospital
Frank P. Vleggaar
Department of Gastroenterology and Hepatology, University Medical Center Utrecht
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.
