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.

Accuracy and clinical outcomes of pancreatic EUS-guided fine-needle biopsy in a consecutive series of 852 specimens.

Background and Objectives: Pancreatic EUS-guided fine needle biopsy (EUS-FNB) is increasingly used. Accuracy of EUS-FNB, particularly for benign diseases, utility of additional EUS-FNB if malignancy is suspected but initial diagnosis is inconclusive, and complication rate are not fully elucidated. We evaluated operating characteristics of EUS-FNB overall and for different diagnostic categories, value of additional EUS-FNB if malignancy is suspected but initial diagnosis is inconclusive, and frequency and type of complications. Methods: A retrospective tertiary single-center study including 852 consecutive pancreatic SharkCore EUS-FNBs from 723 patients between 2015 and 2020. EUS-FNB diagnoses were applied according to Papanicolaou Society's system and each category was further subcategorized. Results: Sufficient tissue cylinders for a histologic diagnosis were obtained in 93.4% (796/852). Accuracy was overall, for malignant, and benign entities 85.6% (confidence interval [CI]: 83.2%-87.9%), 88.3% (CI: 85.9%-90.4%), and 94% (CI: 92.2%-95.5%). Sensitivity and accuracy of EUS-FNB for autoimmune pancreatitis (AIP) (n = 15) was 83.3% (CI: 58.6%-96.4%) and 99.2% (CI: 98.3%-99.7%). Of patients in whom malignancy was suspected but initial EUS-FNB diagnosis was inconclusive, 7.3% (53/723) underwent one or two additional EUS-FNBs, and in 54.7% (29/53) of these, a malignant diagnosis was established. The frequency of hospitalization following EUS-FNB was 4.7%, with 0.2% (n = 2) incidents needing active intervention. Conclusions: We found a high accuracy of pancreatic EUS-FNB across all diagnostic categories including rare entities, such as AIP. In patients with a clinical suspicion of malignancy, additional EUS-FNB resulted in a conclusive diagnosis in more than half of cases. Complications necessitate hospitalization in almost 5%, but the majority are self-limiting.

Risk Prediction Model of 90-Day Mortality After Esophagectomy for Cancer.

Importance: Ninety-day mortality rates after esophagectomy are an indicator of the quality of surgical oncologic management. Accurate risk prediction based on large data sets may aid patients and surgeons in making informed decisions. Objective: To develop and validate a risk prediction model of death within 90 days after esophagectomy for cancer using the International Esodata Study Group (IESG) database, the largest existing prospective, multicenter cohort reporting standardized postoperative outcomes. Design, Setting, and Participants: In this diagnostic/prognostic study, we performed a retrospective analysis of patients from 39 institutions in 19 countries between January 1, 2015, and December 31, 2019. Patients with esophageal cancer were randomly assigned to development and validation cohorts. A scoring system that predicted death within 90 days based on logistic regression ß coefficients was conducted. A final prognostic score was determined and categorized into homogeneous risk groups that predicted death within 90 days. Calibration and discrimination tests were assessed between cohorts. Exposures: Esophageal resection for cancer of the esophagus and gastroesophageal junction. Main Outcomes and Measures: All-cause postoperative 90-day mortality. Results: A total of 8403 patients (mean [SD] age, 63.6 [9.0] years; 6641 [79.0%] male) were included. The 30-day mortality rate was 2.0% (n = 164), and the 90-day mortality rate was 4.2% (n = 353). Development (n = 4172) and validation (n = 4231) cohorts were randomly assigned. The multiple logistic regression model identified 10 weighted point variables factored into the prognostic score: age, sex, body mass index, performance status, myocardial infarction, connective tissue disease, peripheral vascular disease, liver disease, neoadjuvant treatment, and hospital volume. The prognostic scores were categorized into 5 risk groups: very low risk (score, ≥1; 90-day mortality, 1.8%), low risk (score, 0; 90-day mortality, 3.0%), medium risk (score, -1 to -2; 90-day mortality, 5.8%), high risk (score, -3 to -4: 90-day mortality, 8.9%), and very high risk (score, ≤-5; 90-day mortality, 18.2%). The model was supported by nonsignificance in the Hosmer-Lemeshow test. The discrimination (area under the receiver operating characteristic curve) was 0.68 (95% CI, 0.64-0.72) in the development cohort and 0.64 (95% CI, 0.60-0.69) in the validation cohort. Conclusions and Relevance: In this study, on the basis of preoperative variables, the IESG risk prediction model allowed stratification of an individual patient's risk of death within 90 days after esophagectomy. These data suggest that this model can help in the decision-making process when esophageal cancer surgery is being considered and in informed consent.

Short-term outcomes after minimally invasive oesophagectomy.

INTRODUCTION: Minimally invasive oesophagectomy (MIO) has gained increasing popularity. This study reports the results of the first patients operated using this technique at our department. METHODS: All procedures were prospectively registered in a database. Patients were followed until death, two years after surgery or 1 January 2019. RESULTS: A total of 150 procedures were performed (from 23 November 2015 to 27 February 2018). The median proced-ure time decreased from 350 minutes for the initial 75 pa-tients to 320 minutes for the final 75 patients (p < 0.05). Blood loss decreased from 200 ml to 100 ml (p < 0.05), respectively. The conversion rate for the abdominal procedure was 7% for the initial 75 patients and 8% for the final 75 patients (not significant (NS)). For the thoracic procedure, the corresponding figures were 11% and 7% (NS), respectively. Anastomotic leakage was seen in 17% (initial patients) and 11% (final patients) (NS); however, less than 20% of the leakages needed surgical treatment. The median length of post-operative stay was nine days for both groups. For all 150 patients, pulmonary complications were observed in 18% and cardiac complications in 11%. The 30-day mortality rate was 2% and the one-year survival rate was 86% (124 registered patients). CONCLUSIONS: MIO was introduced at our department with acceptable morbidity and mortality rates and the short-term oncological result was not compromised. FUNDING: none. TRIAL REGISTRATION: The study was approved as a quality project by the Region of Southern Denmark (18/37355).

[Injuries associated with unpowered scooters. Treatment at the Odense University Hospital 1996-2001]. / Skader ved brug af løbehjul. Behandlet ved Odense universitetshospital 1996-2001.

INTRODUCTION: Since the beginning of the nineties, skate-boards, in-liners, roller skates, and during the past years non-powered scooters have gained increasing popularity. This surge of enthusiasm has resulted in an increasing number of injuries involving scooters. MATERIAL AND METHODS: The subject of our study was to ascertain injuries resulting from scooter usage based on consecutive sampling of patients treated at the casualty department of Odense University Hospital in Denmark between January 1st 1996 and December 31st 2001. RESULTS: 162 patients were registered. 86% of the injuries occurred in the years 2000 and 2001. The major part took place among children under the age of fifteen (93% of all). 94% of the injuries were sustained because the person tumbled when scooting. The injuries were distributed as follows: skull/face 51 (32%), upper extremity 78 (48%), lower extremity 31 (17%), and trunk 2 (1%). 43 persons sustained a fracture of which 32 (74%) were located to the upper extremity. DISCUSSION: Based on the distribution of severe injuries by body regions the results advocates usage of wrist protection at all ages when using a scooter, and parents are advised to restrict usage of scooters to children above the age of eight. Furthermore the study underlines the need for precise registration and code procedures in the emergency room. Otherwise injuries resulting from new products or behaviours cannot be identified.