Randomized controlled trial of nasogastric tube use after esophagectomy: study protocol for the kinetic trial.

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.

Outcome after stent and endoscopic vacuum therapy-based treatment for postemetic esophageal rupture.

OBJECTIVES: Extent of surgical repair of spontaneous esophageal effort rupture (Boerhaave syndrome) has gradually decreased by the emergence of minimal invasive treatment based on endoscopic stent sealing of the perforation. However, for this diagnosis, use of endoscopic vacuum therapy (EVT) is still in its beginning. We present our results after 7-years with both stent and/or EVT-based treatment. MATERIALS AND METHODS: 17 consecutive patients with Boerhaave syndrome from June 2015 to May 2022 were retrospectively registered in a database. The perforation was sealed by stent and/or EVT, and gastric effluent was drained transthoracically by a chest tube or pigtail catheter. Eight out of 14 patients responded to questions on fatigue and dysphagia (Ogilvie's score). RESULTS: Seventeen patients aged median 67 years (range 34-88), had a primary hospital stay of 38 days (7-68). Ninety-day mortality was 6% (n = 1). Perforations were sealed with stent (n = 10), EVT (n = 3) or stent and EVT (n = 4). One patient (6%) needed laparoscopic lavage and transhiatal drainage. Eight patients (47%) were re-stented due to persistent leakage (n = 4) and stent migration (n = 4). Fifteen patients (88%) had complications, including multi-organ failure (n = 9), pleural empyema (n = 8) and esophageal stricture (n = 3). The perforations healed. After 35.5 months (range 2-62) fourteen patients were alive. Eight that responded had no dysphagia and total fatigue score comparable to an age-matched reference population. CONCLUSION: Mortality rate was low after initial stent and EVT-based treatment of Boerhaave syndrome, combined with adequate transthoracic drainage of gastric effluent. Patients required repeated minimal invasive procedures, but with no apparent negative effect on functional outcome.

Effect of AndoSan™ on expression of adhesion molecules and production of reactive oxygen species in human monocytes and granulocytes in vivo.

BACKGROUND: Oral intake (60 ml daily) over 12 days in eight healthy volunteers of an immunostimulatory extract based on the medicinal mushroom Agaricus blazei Murill (AbM (AndoSan™)), reduced the monocyte and granulocyte release of mainly proinflammatory cytokines in vivo, suggesting an anti-inflammatory effect. In this foremost in vivo study, the aim was to examine the effect of such AndoSan™ consumption on the expression of adhesion molecules CD11b, CD11c and CD62L and production of reactive oxygen species (ROS) in leukocytes. METHODOLOGY/PRINCIPAL FINDINGS: As shown by flow cytometry, there was a significant increase of CD62L expression on monocytes and granulocytes from before (day 0) compared with 12 days after daily AndoSan™ consumption. However, only minor alterations and no clear trend in the expression of CD11b and CD11c were detected. Intracellular ROS (mainly superoxide ion) were significantly reduced in these cells from days 0 to 12. CONCLUSIONS/SIGNIFICANCE: These results support that oral intake of AndoSan™ exhibits an anti-inflammatory effect in humans in vivo.