Randomized controlled trial of nasogastric tube use after esophagectomy: study protocol for the kinetic trial
Hedberg, Jakob; Sundbom, Magnus; Edholm, David; Aahlin, Eirik Kjus; Szabo, Eva; Lindberg, Fredrik; Johnsen, Gjermund; Førland, Dag Tidemann; Johansson, Jan; Kauppila, Joonas H; Svendsen, Lars Bo; Nilsson, Magnus; Lindblad, Mats; Lagergren, Pernilla; Larsen, Michael Hareskov; Åkesson, Oscar; Löfdahl, Per; Mala, Tom; Achiam, Michael Patrick (2024-02-16)
Oxford University Press
16.02.2024
Jakob Hedberg, Magnus Sundbom, David Edholm, Eirik Kjus Aahlin, Eva Szabo, Fredrik Lindberg, Gjermund Johnsen, Dag Tidemann Førland, Jan Johansson, Joonas H Kauppila, Lars Bo Svendsen, Magnus Nilsson, Mats Lindblad, Pernilla Lagergren, Michael Hareskov Larsen, Oscar Åkesson, Per Löfdahl, Tom Mala, Michael Patrick Achiam, Randomized controlled trial of nasogastric tube use after esophagectomy: study protocol for the kinetic trial, Diseases of the Esophagus, Volume 37, Issue 6, June 2024, doae010, https://doi.org/10.1093/dote/doae010
https://creativecommons.org/licenses/by/4.0/
© The Author(s) 2024. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
https://creativecommons.org/licenses/by/4.0/
© The Author(s) 2024. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
https://creativecommons.org/licenses/by/4.0/
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:oulu-202405203709
https://urn.fi/URN:NBN:fi:oulu-202405203709
Tiivistelmä
Summary
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.
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.
Kokoelmat
- Avoin saatavuus [38824]
Ellei muuten mainita, aineiston lisenssi on https://creativecommons.org/licenses/by/4.0/