This scoring system predicted cancer-specific survival in patients who did not meet the curative criteria after ESD for EGC. ESD without additional treatment may be an acceptable option for patients at low risk.

This multi-center study, representing the largest cohort to date, revealed a large discrepancy between OS and DSS in the two groups. Since follow-up with no additional treatment after ESD may be an acceptable option for patients at low risk, further risk stratification is needed for appropriate individualized treatment strategies.

Sedation in gastroenterological endoscopy has become an important medical option in routine clinical care. Here, the Japan Gastroenterological Endoscopy Society and the Japanese Society of Anesthesiologists together provide the revised "Guidelines for sedation in gastroenterological endoscopy" as a second edition to address on-site clinical questions and issues raised for safe examination and treatment using sedated endoscopy. Twenty clinical questions were determined and the strength of recommendation and evidence quality (strength) were expressed according to the "MINDS Manual for Guideline Development 2017." We were able to release upto-date statements related to clinical questions and current issues relevant to sedation in gastroenterological endoscopy (henceforth, "endoscopy"). There are few reports from Japan in this field (e.g., meta-analyses), and many aspects have been based only on a specialist consensus. In the current scenario, benzodiazepine drugs primarily used for sedation during gastroenterological endoscopy are not approved by national health insurance in Japan, and investigations regarding expense-related disadvantages have not been conducted. Furthermore, including the perspective of beneficiaries (i.e., patients and citizens) during the creation of clinical guidelines should be considered. These guidelines are standardized based on up-to-date evidence quality (strength) and supports on-site clinical decision-making by patients and medical staff. Therefore, these guidelines need to be flexible with regard to the wishes, age, complications, and social conditions of the patient, as well as the conditions of the facility and discretion of the physician.

ObjectiveBleeding after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is a frequent adverse event after ESD. We aimed to develop and externally validate a clinically useful prediction model (BEST-J score: Bleeding after ESD Trend from Japan) for bleeding after ESD for EGC.DesignThis retrospective study enrolled patients who underwent ESD for EGC. Patients in the derivation cohort (n=8291) were recruited from 25 institutions, and patients in the external validation cohort (n=2029) were recruited from eight institutions in other areas. In the derivation cohort, weighted points were assigned to predictors of bleeding determined in the multivariate logistic regression analysis and a prediction model was established. External validation of the model was conducted to analyse discrimination and calibration.ResultsA prediction model comprised 10 variables (warfarin, direct oral anticoagulant, chronic kidney disease with haemodialysis, P2Y12 receptor antagonist, aspirin, cilostazol, tumour size >30 mm, lower-third in tumour location, presence of multiple tumours and interruption of each kind of antithrombotic agents). The rates of bleeding after ESD at low-risk (0 to 1 points), intermediate-risk (2 points), high-risk (3 to 4 points) and very high-risk (≥5 points) were 2.8%, 6.1%, 11.4% and 29.7%, respectively. In the external validation cohort, the model showed moderately good discrimination, with a c-statistic of 0.70 (95% CI, 0.64 to 0.76), and good calibration (calibration-in-the-large, 0.05; calibration slope, 1.01).ConclusionsIn this nationwide multicentre study, we derived and externally validated a prediction model for bleeding after ESD. This model may be a good clinical decision-making support tool for ESD in patients with EGC.

Japanese guidelines for gastric cancer treatment were first published in 2001 for the purpose of showing the appropriate indication for each treatment method, thereby reducing differences in the therapeutic approach among institutions, and so on. With the accumulation of evidence and the development and prevalence of endoscopic submucosal dissection (ESD), the criteria for the indication and curability of endoscopic resection (ER) for early gastric cancer (EGC) have expanded. However, several problems still remain. Although a risk-scoring system (eCura system) for predicting lymph node metastasis (LNM) may help treatment decision in patients who do not meet the curative criteria for ER of EGC, which is referred to as eCura C-2 in the latest guidelines, additional gastrectomy with lymphadenectomy may be excessive for many patients, even those at high risk for LNM. Less-invasive function-preserving surgery, such as non-exposed endoscopic wall-inversion surgery with laparoscopic sentinel node sampling, may overcome this problem. In addition, further less-invasive treatment, such as ER with chemotherapy, should be established for patients who prefer not to undergo additional gastrectomy. CONCEPT AND UPDATE OF THE JAPANESE GUIDELINESJ APANESE GASTRIC CANCER Association (JGCA) guidelines were first published in 2001 9 for the purpose of: (i) showing the appropriate indication of each treatment method for gastric cancer; (ii) reducing differences in the therapeutic approach among institutions; (iii) improving the safety and outcome of treatment for gastric cancer; (iv) reducing the personnel and economic burden by avoiding unnecessary treatment; and (v) improving mutual understanding between medical staff and patients. With the accumulation of evidence, the guidelines were updated in