Explore the vast range of titles available.

BackgroundEndoscopic resection has been limited to intestinal-type gastric cancer (cT1a) with a low risk of lymph node metastasis (T1a ≤2 cm, without ulcers). This single-arm confirmatory trial evaluated the efficacy and safety of endoscopic submucosal dissection (ESD) for >2 cm ulcer-negative and ≤3 cm ulcer-positive intestinal-type gastric cancer (cT1a).MethodsThe eligibility criteria included endoscopically diagnosed cT1a, a single primary intestinal-type gastric adenocarcinoma, an ulcer-negative lesion of any size or a ≤3 cm ulcer-positive lesion, cN0M0, and no prior treatment. If ESD resulted in noncurative resection, surgical resection was added. The primary endpoint was the 5-year overall survival (OS) (planned sample size was 470, with a one-sided alpha level of 2.5%). The threshold 5-year OS was 86.1%.ResultsWe enrolled 470 early gastric cancer patients [median tumor size, 25 (5–130) mm] from 29 institutions between June 2007 and October 2010. These patients had 152 ulcer-negative lesions (>2 and ≤3 cm), 111 ulcer-negative lesions (>3 cm), and 207 ulcer-positive lesions (≤3 cm). The success rate for en block resection was 99.1% (466/470). Additional gastrectomy was conducted in 131 patients (28%) who did not fulfill the curative resection criteria. The 5-year OS of all patients was 97.0% (95% confidence interval, 95.0–98.2%), which was higher than the threshold 5-year OS (86.1%). The 317 patients who satisfied the curative resection criteria had no recurrence. There were no ESD-related grade 4 adverse events.ConclusionESD for early gastric cancers that met the expanded criteria for intestinal-type gastric cancer (cT1a) was acceptable and should be the standard treatment instead of gastrectomy.

BackgroundWhile endoscopic submucosal dissection (ESD) is recognized as a minimally invasive standard treatment for differentiated early gastric cancers (EGCs), it has not been indicated for undifferentiated EGC (UD-EGC) because of a relatively high risk of lymph node metastasis (LNM). However, patients with surgically resected mucosal (cT1a) UD-EGC ≤ 2 cm in size with no lymphovascular invasion or ulceration are reported to be at a very low risk of LNM. This multicenter, single-arm, confirmatory trial was conducted to evaluate the efficacy and safety of ESD for UD-EGC.MethodsThe key eligibility criteria were endoscopically diagnosed cT1a/N0/M0, single primary lesion, size ≤ 2 cm, no ulceration and histologically proven components of undifferentiated adenocarcinoma on biopsy. Based on the histological findings after ESD, additional gastrectomy was indicated if the criteria for curative resection were not satisfied. The subjects of the primary analysis were patients with UD-EGC as the dominant component. The primary endpoint was 5-year overall survival (OS) of patients with UD-EGC.ResultsThree hundred 46 patients were enrolled from 49 institutions. The proportion of en bloc resection was 99%. No ESD-related Grade 4 adverse events were noted. Delayed bleeding and intraoperative and delayed perforation occurred in 25 (7.3%), 13 (3.8%), and 6 (1.7%) patients, respectively. Among the 275 patients who were the subjects of the primary analysis, curative resection was achieved in 195 patients (71%), and 5-year OS was 99.3% (95% CI: 97.1–99.8).ConclusionsESD can be a curative and less invasive treatment for UD-EGC for patients meeting the eligibility criteria of this study.

In order to screen for gastric cancer effectively, its interval should be set according to the risk. This study aimed to determine whether risk stratification is possible using the data obtained from medical examination or endoscopic findings. First, subjects who underwent both cancer screening and medical examination from 2009 to 2015 and underwent cancer screening once more by 2016 were studied. Data such as the lipid profile and history of smoking obtained during the medical examination, and the grade of atrophy and presence of peptic ulcers were studied using multivariate analysis. Next, subjects who underwent cancer screening twice or more between 2009 and 2015 with or without medical examinations were studied to analyze any correlation between the grade of atrophy and cancer occurrence using univariate analysis. In both studies, the status of Helicobacter pylori (HP) infection was determined. In the multivariate analysis, 9378 subjects were included. Aging, advanced atrophy, presence of ulcers, and uric acid levels were identified as risk factors. Among subjects who underwent successful HP eradication therapy, advanced atrophy and aging were observed to be crucial risk factors. In the univariate analysis, there were 12,941 subjects. Gastric cancer occurred more frequently in the more severe atrophy group (P < 0.001). The annual rate of cancer occurrence in the most severe atrophy group was 0.31%, which was approximately thrice as that in the less atrophy group. Risk stratification was possible based on endoscopic examination alone. The interval should be set depending on each case.

Background Curative treatment of patients with gastric cancer requires reliable detection of early gastric cancer. Magnifying endoscopy with narrow-band imaging (M-NBI) is useful for the accurate preoperative diagnosis of early gastric cancer. However, the role of M-NBI in screening endoscopy has not been established. The aims of this study were to determine the feasibility and limitations of M-NBI in screening endoscopy. Methods We conducted a multicenter prospective uncontrolled trial of patients undergoing routine screening endoscopy patients. We determined the diagnostic accuracy, sensitivity and specificity of M-NBI according to the degree of certainty and need for biopsy, as assessed using the VS (vessel plus surface) classification system. We analyzed the endoscopic and histopathological characteristics of both false negative and false positive high confidence M-NBI diagnoses. We then developed a provisional diagnostic strategy based on the diagnostic performance and limitations identified in this study. Results A total of 1097 patients were enrolled in the study. We analyzed 371 detected lesions (20 cancers and 351 non-cancers). The accuracy, sensitivity and specificity of high confidence M-NBI diagnoses were 98.1, 85.7 and 99.4 %, respectively. The false negative case was a pale mucosal lesion with tissue diagnosis of signet-ring cell carcinoma. Exclusion of pale mucosal lesions increased the accuracy, sensitivity and specificity of high confidence M-NBI diagnoses to 99.4, 100 and 99.4 %, respectively. We therefore propose a practical strategy targeting non-pale mucosal lesions. Conclusions With a refined strategy considering its limitations, M-NBI can act as an “optical biopsy” in screening endoscopies.

BackgroundThere are few reports on the technical difficulty of gastric endoscopic submucosal dissection (ESD). The aim of this study was to investigate the factors associated with the technical difficulty of ESD for early gastric cancer (EGC) using the data from the multicenter non-randomized confirmatory trial of expanded indication criteria of ESD (JCOG0607).MethodsThe major inclusion criteria were as follows: (1) histologically proven intestinal-type adenocarcinoma; (2) cT1aN0M0; (3) lesion without finding of ulcer (UL-negative) with > 2 cm in size, or UL-positive with ≤ 3 cm; (4) age 20–75 years. The difficult case was defined as ESD taking ≥ 120 min, piecemeal resection, and/or developing perforation during procedure.ResultsBetween June 2007 and October 2010, 470 patients were enrolled from 29 institutions. Median procedure time was 79 (range 14–462) min, and it was ≥ 120 min in 127 patients. Twelve patients developed perforation during ESD, and the procedure time was ≥ 120 min in 9 of them. Therefore, 130 patients (27.7%) were identified as difficult cases. Multivariable analysis showed that UL-negative with > 5 cm (vs. UL-negative with ≤ 3 cm, odds ratio, 24.993; 95% CI 6.130–101.897, p < 0.0001) had the largest odds ratio and followed by UL-negative with 3–5 cm upper or middle portion of stomach and age ≤ 60 years were significantly associated with difficulty.ConclusionsUL-negative lesion with > 3 cm, upper or middle portion of stomach and age ≤ 60 years were independent factors associated with technical difficulty of ESD for EGC. Trial registered number was UMIN000000737.

BackgroundMagnifying endoscopy with narrow-band imaging (NBI) is effective for the diagnosis of early gastric cancer (EGC). However, magnifying endoscopy is not yet popular globally because of the required level of skill and lack of availability. To overcome these problems, dual-focus endoscopy (standard- and near-focus (NF) modes) has been developed. In this study, we evaluated the diagnostic performance of NF with second-generation (2G)-NBI (NF-NBI) for the diagnosis of EGC.MethodsThis was a secondary analysis of a multicenter randomized controlled trial of 4523 high-risk patients who underwent gastroscopies at 13 institutions in Japan. Patients were randomly assigned to white-light imaging (WLI) followed by 2G-NBI or to 2G-NBI followed by WLI. Lesions suspicious for EGC, newly detected by non-magnifying WLI or 2G-NBI, were subsequently observed with NF-NBI. All detected lesions were biopsied or resected. The diagnostic performance of NF-NBI was compared with the final histology.ResultsA total of 870 detected lesions (145 EGC, 725 non-EGC) were analyzed. Overall diagnostic performance for EGC using NF-NBI was accuracy 87.7%, sensitivity 60.7%, specificity 93.1%, positive predictive value 63.8%, and negative predictive value 92.2%. There were no significant differences in diagnostic performance between lesions detected by WLI or 2G-NBI. For lesions diagnosed with high (333 lesions) and low (537 lesions) confidences, accuracy was 92.2% and 84.9%, sensitivity was 64.7% and 58.5%, and specificity was 90.5% and 88.8%, respectively.ConclusionThe diagnostic performance of NF-NBI is good and acceptable for diagnosis of EGC in combination with either WLI or 2G-NBI.

Objectives Overlooking early gastric cancer (EGC) during endoscopy is an issue to be resolved. Image‐enhanced endoscopy is expected to improve EGC detection. This study investigated the usefulness of third‐generation narrow band imaging (3G‐NBI) and texture and color enhancement imaging (TXI) in improving the visibility of EGC using the color difference between EGC and its surrounding gastric mucosa. Methods In this retrospective observational study, we examined 51 superficial EGCs that underwent endoscopic submucosal dissection and were observed by all three methods: 3G‐NBI, TXI, and white light imaging (WLI). The primary endpoint was to compare the color difference of each method. For each EGC, we prepared one non‐magnifying image for each method so that the location and size of the lesion in each image were the same. The L*a*b* color space was used to evaluate the color values. When the color values of the cancerous lesion and its surrounding mucosa were (L*c, a*c, b*c) and (L*s, a*s, b*s), respectively, the color difference was defined to be [(L*c−L*s)2+(a*c−a*s)2+(b*c−b*s)2]1/2. Results The median color difference was 9.2 (interquartile range, 5.3–15.7) in WLI, 13.5 (interquartile range, 9.4–19.5) in 3G‐NBI, and 15.3 (interquartile range, 9.1–22.1) in TXI. Statistically, the color difference was significantly larger in 3G‐NBI than in WLI (p < 0.001) and TXI compared with WLI (p < 0.001). However, there was no significant difference between 3G‐NBI and TXI (p = 0.330). Conclusions Regarding color difference, both 3G‐NBI and TXI were estimated to be more useful than WLI in improving the visibility of superficial EGC.

Objective The indications for endoscopic submucosal dissection (ESD) in patients with early gastric cancer (EGC) have been expanded. However, the long-term outcomes of ESD remain unclear. We retrospectively investigated the long-term outcomes of ESD in patients with EGC. Methods We retrospectively studied patients with EGC who underwent ESD at 11 institutions between January 2003 and December 2010. A total of 6456 patients (7979 lesions) who met the absolute indications for ESD and 4202 patients (5781 lesions) who met the expanded indications for ESD were studied. Clinicopathological features, clinical course, and outcomes were studied in 67 patients in whom local recurrence or metastatic recurrence was diagnosed as of March 31, 2014. The median follow-up period was 56 months. Results Local recurrence was diagnosed in 14 patients (0.22%) who met the absolute indications and 53 patients (1.26%) who met the expanded indications. The rate of local recurrence was significantly higher in patients with expanded-indication lesions ( p  < 0.05). As additional treatment for recurrence, most patients received endoscopic treatment. Metastatic recurrence did not develop in any patient with absolute-indication lesions, but was diagnosed in 6 patients (0.14%) with expanded-indication lesions ( p  < 0.05). The histological type was undifferentiated mixed type in half the patients. Three patients died of primary gastric cancer. Conclusions ESD for expanded-indication lesions of EGC is considered an effective therapy associated with an extremely low rate of metastatic recurrence on long-term follow-up. However, fully informed consent concerning the risk of metastatic recurrence should be obtained before ESD, and close postoperative follow-up is essential.

Background and aimsDelayed bleeding after gastric endoscopic submucosal dissection (ESD) in patients receiving anticoagulants remains an unpreventable adverse event. Although direct-acting oral anticoagulants (DOACs) have superior efficacy in preventing thromboembolism, their effects on the occurrence of delayed bleeding remain unclear. This study aimed to elucidate the clinical effect of DOACs on delayed bleeding after gastric ESD.Patients and methodsWe retrospectively examined 728 patients who received anticoagulants and were treated for gastric neoplasms with ESD in 25 institutions across Japan. Overall, 261 patients received DOACs, including dabigatran (92), rivaroxaban (103), apixaban (45) and edoxaban (21), whereas 467 patients were treated with warfarin.ResultsDelayed bleeding occurred in 14% of patients taking DOACs, which was not considerably different in patients receiving warfarin (18%). Delayed bleeding rate was significantly lower in patients receiving dabigatran than in those receiving warfarin and lower than that observed for other DOACs. Multivariate analysis showed that age ≥ 65, receiving multiple antithrombotic agents, resection of multiple lesions and lesion size ≥ 30 mm were independent risk factors, and that discontinuation of anticoagulants was associated with a decreased risk of bleeding. In multivariate analysis among patients taking DOACs, dabigatran therapy was associated with a significantly lower risk of delayed bleeding.ConclusionsThe effects of DOACs on delayed bleeding varied between agents, but dabigatran therapy was associated with the lowest risk of delayed bleeding. Switching oral anticoagulants to dabigatran during the perioperative period could be a reasonable option to reduce the risk of delayed bleeding after gastric ESD.