Randomized controlled trial of nasogastric tube use after esophagectomy : study protocol for the kinetic trial
(2024) In Diseases of the Esophagus p.1-6- Abstract
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... (More)
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.
(Less)
- author
- publishing date
- 2024-02-16
- type
- Contribution to journal
- publication status
- epub
- in
- Diseases of the Esophagus
- pages
- 1 - 6
- publisher
- Oxford University Press
- external identifiers
-
- pmid:38366900
- ISSN
- 1120-8694
- DOI
- 10.1093/dote/doae010
- language
- English
- LU publication?
- no
- additional info
- © The Author(s) 2024. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus.
- id
- d7462587-aea3-4914-8605-f9a1d351fd7a
- date added to LUP
- 2024-02-19 07:12:42
- date last changed
- 2024-02-19 08:13:59
@article{d7462587-aea3-4914-8605-f9a1d351fd7a,
abstract = {{<p>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.</p>}},
author = {{Hedberg, Jakob and Sundbom, Magnus and Edholm, David and Aahlin, Eirik Kjus and Szabo, Eva and Lindberg, Fredrik and Johnsen, Gjermund and Førland, Dag Tidemann and Johansson, Jan and Kauppila, Joonas H and Svendsen, Lars Bo and Nilsson, Magnus and Lindblad, Mats and Lagergren, Pernilla and Larsen, Michael Hareskov and Åkesson, Oscar and Löfdahl, Per and Mala, Tom and Achiam, Michael Patrick}},
issn = {{1120-8694}},
language = {{eng}},
month = {{02}},
pages = {{1--6}},
publisher = {{Oxford University Press}},
series = {{Diseases of the Esophagus}},
title = {{Randomized controlled trial of nasogastric tube use after esophagectomy : study protocol for the kinetic trial}},
url = {{http://dx.doi.org/10.1093/dote/doae010}},
doi = {{10.1093/dote/doae010}},
year = {{2024}},
}