TY - JOUR

T1 - Randomized controlled trial of nasogastric tube use after esophagectomy

T2 - study protocol for the kinetic trial

AU - Hedberg, Jakob

AU - Sundbom, Magnus

AU - Edholm, David

AU - Aahlin, Eirik Kjus

AU - Szabo, Eva

AU - Lindberg, Fredrik

AU - Johnsen, Gjermund

AU - Førland, Dag Tidemann

AU - Johansson, Jan

AU - Kauppila, Joonas H.

AU - Svendsen, Lars Bo

AU - Nilsson, Magnus

AU - Lindblad, Mats

AU - Lagergren, Pernilla

AU - Larsen, Michael Hareskov

AU - Åkesson, Oscar

AU - Löfdahl, Per

AU - Mala, Tom

AU - Achiam, Michael Patrick

N1 - © The Author(s) 2024. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus.

PY - 2024/2/16

Y1 - 2024/2/16

N2 - 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.

AB - 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.

U2 - 10.1093/dote/doae010

DO - 10.1093/dote/doae010

M3 - Journal article

C2 - 38366900

JO - Diseases of the Esophagus (Print)

JF - Diseases of the Esophagus (Print)

SN - 1120-8694

ER -