Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Introduction: Gastric outlet obstruction is a common manifestation of advanced gastric, duodenal, and periampullary malignancies, severely affecting quality of life.Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) may be superior to surgical gastroenterostomy (SGJ) as palliative treatment for this condition, but randomised trials are currently lacking. Aims & Methods:We performed a multicenter, randomized controlled trial involving palliative patients with a malignant obstruction localized between the pylorus and the distal duodenum, randomizing them 1:1 to either EUS-GE or SGJ.The first co-primary superiority end point was time to solid oral intake.The second co-primary non-inferiority end point was persistent or recurrent obstructive symptoms for which a reintervention was required within six months after treatment.The predefined non-inferiority margin was 20%.Results: From February 2022 to February 2024, 250 patients were screened in 12 participating hospitals in the Netherlands.Of the 98 enrolled patients, 48 were assigned to EUS-GE and 50 were assigned to SGJ.Median age was 69 versus 70 years and the most prevalent etiology was pancreatic cancer in 58% versus 50% in the EUS-GE group and SGJ group, respectively.Median time to oral intake was significantly shorter in the EUS-GE group compared to the SGJ group: 1 day versus 3 days (hazard ratio, 2.21, 95% CI, 1.43 to 3.42, p=0.0003).In the endoscopic group, 5 patients (10%) experienced persistent or recurrent obstructive symptoms requiring reintervention, compared with 6 patients (12%) in the surgical group (risk difference, 1.6%, upper limit of 90% CI, 8.9%).Clinical success, defined as the ability to tolerate solid oral intake, was higher in the EUS-GE group (96% versus 80%, relative risk, 1.20, 95% CI, 1.03 to 1.39).Median length of hospital stay was shorter in the EUS-GE group (1 day versus 4 days, relative change, 0.46, 95% CI, 0.20 to 0.78).Serious adverse events, defined as Clavien-Dindo ≥3B, were observed in 8% of patients in the EUS-GE group and in 12% of patients in the SGJ group (relative risk, 0.69, 95% CI, 0.21 to 2.31).Median survival was 91 days after EUS-GE (95% CI, 74 to 140) and 74 days (95% CI, 46 to 110) after SGJ.Thirty-day mortality was 13% in the EUS-GE group and 26% in the SGJ group (relative risk, 0.48, 95% CI, 0.20 to 1.14).In the first three months following the procedure, quality of life was not different between the two treatments.Conclusion: This trial showed that EUS-GE, compared to SGJ, is superior in terms of time to solid oral intake and non-inferior with regards to the rate of persistent or recurrent obstructive symptoms requiring reintervention.Based on these results, EUS-GE should be the preferred palliative treatment for malignant gastric outlet obstruction.
DOI: 10.1002/ueg2.70032
Authors: Nyssen, O.P., Ortega, G.J., Jonaitis, Laimas Virginijus, Pérez-Aísa, A., Tepes, B., Lucendo, A.J., Tejedor-Tejeda, J., Bumane, R., Garre, A., Huguet, J.M., Perona, M., Núñez Martínez, O., Pabón-Carrasco, M., Castro-Fernandez, M., Areia, M., Barrio, J., Moreno, A., Butler, T., Soledad Marcos, M., Keco-Huerga, A., Dominguez Cajal, M., Denkovski, M., Pavoni, M., Buzas, G.M., Lerang, F., Losurdo, G., Wolfe Garcia, P.M., Phull, P.S., Martínez-Domínguez, S.J., Kupčinskas, Juozas, Leja, M., Pinto, R., Smith, S., Gasbarrini, A., Papp, V., Gomez-Rogriguez, B.J., Sanchez Alonso, M., Pajares Villaroya, R., Pazo Mejide, P., Jiménez-Moreno, M., Pascual-Mato, M., Bravo-Pache, C., Montes, M., Cano-Catala, A., Parra, P., Moreira Ruiz, L., Megraud, F., O'Morain, C., Bujanda, L., Gisbert, J.P., Hp-EuReg investigators
Language: English
Topic: Esophageal and GI Pathology
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $2,930
Funders: Boston Scientific Corporation, Norges Teknisk-Naturvitenskapelige Universitet, Cook Medical, Fundación Instituto de Investigación Sanitaria de Santiago de Compostela, Instituto de Investigación Sanitaria de Santiago de Compostela, Consorzio Interuniversitario Nazionale per la Scienza e Tecnologia dei Materiali, Amsterdam University Medical Centers, Institut National de la Santé et de la Recherche Médicale, Universiteit Leiden, Radboud Universiteit, Universität Wien, Universidad Autónoma de Madrid, Leids Universitair Medisch Centrum, Medizinische Universität Wien, Università degli Studi di Brescia, Karl-Franzens-Universität Graz, Assistance publique-Hôpitaux de Paris, Medizinische Universität Graz, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Investigación Marqués de Valdecilla, Sorbonne Université, BioTechMed-Graz, Instituto de Investigación Sanitaria del Principado de Asturias, Servicio Gallego de Salud
OpenAlex ID: W4414830410