Randomized controlled trial of nasogastric tube use after esophagectomy: study protocol for the kinetic trialDepartment of Surgery, Örebro University, Örebro, Sweden.
Umeå University, Faculty of Medicine, Department of Surgical and Perioperative Sciences, Surgery. Umeå University, Faculty of Medicine, Department of Diagnostics and Intervention.
Department of Gastrointestinal Surgery, Norwegian University of Science and Technology, Trondheim, Norway.
Department of Pediatric and Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway.
Department of Surgery, Skane University Hospital, Lund, Sweden.
Department of Surgery, University of Oulu and Oulu University Hospital, Oulu, Finland.
Department of Surgery and Transplantation, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institutet, Stockholm, Sweden; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institutet, Stockholm, Sweden.
Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockhom, Sweden; Department of Surgery and Cancer, Imperial College London, London, United Kingdom.
Department of Surgery, Odense University Hospital, Odense, Denmark.
Department of Surgery, Skane University Hospital, Lund, Sweden.
Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
Department of Pediatric and Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway.
Department of Surgery and Transplantation, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
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2024 (English)In: Diseases of the esophagus, ISSN 1120-8694, E-ISSN 1442-2050, Vol. 37, no 6, article id doae010Article in journal (Refereed) Published
Abstract [en]
Esophagectomy is a complex and complication laden procedure. Despite centralization, variations in perioparative strategies reflect a paucity of evidence regarding optimal routines. The use of nasogastric (NG) tubes post esophagectomy is typically associated with significant discomfort for the patients. We hypothesize that immediate postoperative removal of the NG tube is non-inferior to current routines. All Nordic Upper Gastrointestinal Cancer centers were invited to participate in this open-label pragmatic randomized controlled trial (RCT). Inclusion criteria include resection for locally advanced esophageal cancer with gastric tube reconstruction. A pretrial survey was undertaken and was the foundation for a consensus process resulting in the Kinetic trial, an RCT allocating patients to either no use of a NG tube (intervention) or 5 days of postoperative NG tube use (control) with anastomotic leakage as primary endpoint. Secondary endpoints include pulmonary complications, overall complications, length of stay, health related quality of life. A sample size of 450 patients is planned (Kinetic trial: https://www.isrctn.com/ISRCTN39935085). Thirteen Nordic centers with a combined catchment area of 17 million inhabitants have entered the trial and ethical approval was granted in Sweden, Norway, Finland, and Denmark. All centers routinely use NG tube and all but one center use total or hybrid minimally invasive-surgical approach. Inclusion began in January 2022 and the first annual safety board assessment has deemed the trial safe and recommended continuation. We have launched the first adequately powered multi-center pragmatic controlled randomized clinical trial regarding NG tube use after esophagectomy with gastric conduit reconstruction.
Place, publisher, year, edition, pages
Oxford University Press, 2024. Vol. 37, no 6, article id doae010
Keywords [en]
complications, esophagectomy, surgery, trials
National Category
Surgery
Identifiers
URN: urn:nbn:se:umu:diva-225958DOI: 10.1093/dote/doae010ISI: 001163656400001PubMedID: 38366900Scopus ID: 2-s2.0-85195052888OAI: oai:DiVA.org:umu-225958DiVA, id: diva2:1868596
Funder
Swedish Cancer Society, CAN 2021/10862024-06-122024-06-122025-03-21Bibliographically approved