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.

Performance and clinical applicability of machine learning in liver computed tomography imaging: a systematic review.

OBJECTIVES: Machine learning (ML) for medical imaging is emerging for several organs and image modalities. Our objectives were to provide clinicians with an overview of this field by answering the following questions: (1) How is ML applied in liver computed tomography (CT) imaging? (2) How well do ML systems perform in liver CT imaging? (3) What are the clinical applications of ML in liver CT imaging? METHODS: A systematic review was carried out according to the guidelines from the PRISMA-P statement. The search string focused on studies containing content relating to artificial intelligence, liver, and computed tomography. RESULTS: One hundred ninety-one studies were included in the study. ML was applied to CT liver imaging by image analysis without clinicians' intervention in majority of studies while in newer studies the fusion of ML method with clinical intervention have been identified. Several were documented to perform very accurately on reliable but small data. Most models identified were deep learning-based, mainly using convolutional neural networks. Potentially many clinical applications of ML to CT liver imaging have been identified through our review including liver and its lesion segmentation and classification, segmentation of vascular structure inside the liver, fibrosis and cirrhosis staging, metastasis prediction, and evaluation of chemotherapy. CONCLUSION: Several studies attempted to provide transparent result of the model. To make the model convenient for a clinical application, prospective clinical validation studies are in urgent call. Computer scientists and engineers should seek to cooperate with health professionals to ensure this. KEY POINTS: • ML shows great potential for CT liver image tasks such as pixel-wise segmentation and classification of liver and liver lesions, fibrosis staging, metastasis prediction, and retrieval of relevant liver lesions from similar cases of other patients. • Despite presenting the result is not standardized, many studies have attempted to provide transparent results to interpret the machine learning method performance in the literature. • Prospective studies are in urgent call for clinical validation of ML method, preferably carried out by cooperation between clinicians and computer scientists.

Neoadjuvant Chemoradiotherapy and Surgery for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed: The Study Protocol for the Randomized Controlled NEEDS Trial.

Background: The globally dominant treatment with curative intent for locally advanced esophageal squamous cell carcinoma (ESCC) is neoadjuvant chemoradiotherapy (nCRT) with subsequent esophagectomy. This multimodal treatment leads to around 60% overall 5-year survival, yet with impaired post-surgical quality of life. Observational studies indicate that curatively intended chemoradiotherapy, so-called definitive chemoradiotherapy (dCRT) followed by surveillance of the primary tumor site and regional lymph node stations and surgery only when needed to ensure local tumor control, may lead to similar survival as nCRT with surgery, but with considerably less impairment of quality of life. This trial aims to demonstrate that dCRT, with selectively performed salvage esophagectomy only when needed to achieve locoregional tumor control, is non-inferior regarding overall survival, and superior regarding health-related quality of life (HRQOL), compared to nCRT followed by mandatory surgery, in patients with operable, locally advanced ESCC. Methods: This is a pragmatic open-label, randomized controlled phase III, multicenter trial with non-inferiority design with regard to the primary endpoint overall survival and a superiority hypothesis for the experimental intervention dCRT with regard to the main secondary endpoint global HRQOL one year after randomization. The control intervention is nCRT followed by preplanned surgery and the experimental intervention is dCRT followed by surveillance and salvage esophagectomy only when needed to secure local tumor control. A target sample size of 1200 randomized patients is planned in order to reach 462 events (deaths) during follow-up. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04460352.

A man in his sixties with dyspnoea and oedema. / Mann i 60-årene med tungpustethet og ødemer.

BACKGROUND/CASE PRESENTATION: A man in his sixties with chronic obstructive pulmonary disease was hospitalised due to oedema and dyspnoea during the previous weeks. He was hypertensive, with 10 kg weight gain, generalised oedema, proximal myopathy and moon face. The assessment was consistent with ectopic ACTH-dependent Cushing's syndrome. A 15 mm lung tumour was detected on CT, with inconclusive cytological examination, and negative FDG/PET CT and octreotide scintigraphy. He developed necrotising pancreatitis and a duodenal perforation, which were surgically treated. His cortisol levels and Cushingoid appearance normalised after surgery, and it was concluded that his hypercortisolism was part of a physiological response. He remained clinically in habitual shape until two years later, when he again developed Cushingoid stigmata. A new octreotide scintigraphy was negative, but FDG/PET CT revealed increased FDG uptake in the lung lesion. Before a lung biopsy was performed, the patient developed necrotising pancreatitis. He was treated conservatively and died in respiratory failure. Autopsy revealed a NET in the lung and necrotising pancreatitis. INTERPRETATION: The case demonstrates diagnostic challenges in the assessment of ectopic ACTH-dependent cyclic Cushing's syndrome. Is also suggests that pancreatitis could be triggered by hypercortisolism.

Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer.

OBJECTIVE: To investigate if prolonged TTS after completed nCRT improves postoperative outcomes for esophageal and esophagogastric junction cancer. SUMMARY OF BACKGROUND DATA: TTS has traditionally been 4-6 weeks after completed nCRT. However, the optimal timing is not known. METHODS: A multicenter clinical trial was performed with randomized allocation of TTS of 4-6 or 10-12 weeks. The primary endpoint of this sub-study was overall postoperative complications defined as Clavien-Dindo grade II-V. Secondary endpoints included complication severity according to Clavien-Dindo grade IIIb-V, postoperative 90-day mortality, and length of hospital stay. The study was registered in Clinicaltrials.gov (NCT02415101). RESULTS: In total 249 patients were randomized. There were no significant differences between standard TTS and prolonged TTS with regard to overall incidence of complications Clavien-Dindo grade II-V (63.2% vs 72.6%, P = 0.134) or regarding Clavien-Dindo grade IIIb-V complications (31.6% vs 34.9%, P = 0.603). There were no statistically significant differences between standard and prolonged TTS regarding anastomotic leak (P = 0.596), conduit necrosis (P = 0.524), chyle leak (P = 0.427), pneumonia (P = 0.548), and respiratory failure (P = 0.723). In the standard TTS arm 5 patients (4.3%) died within 90 days of surgery, compared to 4 patients (3.8%) in the prolonged TTS arm (P = 1.0). Median length of hospital stay was 15 days in the standard TTS arm and 17 days in the prolonged TTS arm (P = 0.234). CONCLUSION: The timing of surgery after completed nCRT for carcinoma of the esophagus or esophagogastric junction, is not of major importance with regard to short-term postoperative outcomes.

Major postoperative complications are associated with impaired long-term survival after gastro-esophageal and pancreatic cancer surgery: a complete national cohort study.

BACKGROUND: Some studies have reported an association between complications and impaired long-term survival after cancer surgery. We aimed to investigate how major complications are associated with overall survival after gastro-esophageal and pancreatic cancer surgery in a complete national cohort. METHODS: All esophageal-, gastric- and pancreatic resections performed for cancer in Norway between January 1, 2008, and December 1, 2013 were identified in the Norwegian Patient Registry together with data concerning major postoperative complications and survival. RESULTS: When emergency cases were excluded, there were 1965 esophageal-, gastric- or pancreatic resections performed for cancer in Norway between 1 January 2008, and 1 December 2013. A total of 248 patients (12.6 %) suffered major postoperative complications. Complications were associated both with increased early (90 days) mortality (OR = 4.25, 95 % CI = 2.78-6.50), and reduced overall survival when patients suffering early mortality were excluded (HR = 1.23, 95 % CI = 1.01-1.50). CONCLUSIONS: Major postoperative complications are associated with impaired long-term survival after gastro-esophageal and pancreatic cancer surgery.