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Endoscopic resection (ER) for early gastric cancer (EGC) can preserve the stomach; however, the remaining stomach can develop second gastric cancer. Few reports have prospectively investigated the incidence and treatment outcomes of second gastric cancer.This post-hoc analysis used the dataset of the single-arm confirmatory trial, JCOG0607. The key inclusion criteria for JCOG0607 were solitary differentiated-type EGC and no previous gastrectomy or endoscopic treatment for EGC. Three hundred seventeen patients who underwent curative ER were included in this study. Surveillance endoscopy was performed 1 to 3 months after the initial ER and subsequently annually for at least 5 years. A lesion detected ≤1 year and1 year after the initial ER was defined as overlooked gastric cancer (OGC) and metachronous gastric cancer (MGC), respectively.During a median follow-up period of 6.0 years (interquartile range, 5.1-7.0), 30 OGCs and 61 MGCs were detected in 24 and 48 patients, respectively. The cumulative incidence of OGC at 1 year and MGC at 5 years was 7.6% and 12.7%, respectively. ER and gastrectomy were performed in 85 lesions and 6 lesions, respectively. Pathologic evaluation showed 78 mucosal cancers, 12 submucosal cancers, and 1 advanced cancer. Eventually, 28 OGCs and 52 MGCs fulfilled the pathologic criteria for curative ER.Our study was the first to reveal the actual incidence of second gastric cancer after curative ER for differentiated-type gastric cancer. Most lesions could be treated with ER. Continuous endoscopic surveillance after curative ER is important to detect second gastric cancer.

The Japan Gastroenterological Endoscopy Society published the second edition of the "Guidelines for Colorectal Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection" in 2019 to clarify the indications for colorectal endoscopic mucosal resection (EMR) and endoscopic submucosal dissection and to ensure appropriate preoperative diagnoses as well as effective and safe endoscopic treatment in front-line clinical settings. Endoscopic resection with electrocautery, including polypectomy and EMR, is indicated for colorectal polyps. Recently, the number of facilities introducing and implementing cold polypectomy without electrocautery has increased. Herein, we establish supplementary guidelines for cold polypectomy. Considering that the level of evidence for each statement is limited, these supplementary guidelines must be verified in clinical practice.

Endoscopic submucosal dissection (ESD) is recommended for the treatment of early gastric cancers with an undifferentiated-type component, clinically diagnosed as intramucosal lesions ≤ 2 cm, without ulceration. In the JCOG1009/1010 trial, ESD could be performed with stomach preservation in 70% of such patients whose pathological findings met the curative resection criteria. However, additional gastrectomy was required for the remaining 30%. We identified the pretreatment risk factors for noncurative resection.Post-hoc analysis indicated that 336 patients were identified in the JCOG1009/1010 trial; among them, 243 and 93 patients were categorized into the curative or noncurative resection groups, respectively, based on the pathological findings of the resected specimens. We explored the pretreatment risk factors for noncurative resection and investigated their associated pathological findings.Multivariable analysis revealed that a pretreatment tumor size 1 cm was an independent risk factor for noncurative resection (odds ratio, 3.538; 95% confidence interval, 2.020-6.198, P 0.0001). Patients with a pretreatment tumor size 1 cm (n = 172) had a histological tumor size 2 cm (22.1% vs 4.3%, odds ratio, 6.313; 95% confidence interval, 2.73-14.599, P 0.0001) and submucosal invasion (17.4% vs 9.1%, odds ratio, 2.000; 95% confidence interval, 1.032-3.877, P = 0.040) more frequently as noncurative resection findings compared with those with a tumor size 1 cm (n = 164).Because pretreatment tumor size 1 cm is an independent risk factor for noncurative resection, endoscopists should be aware that noncurative resection is not uncommon in ESD and fully explain the potential necessity for additional gastrectomy to patients before the procedure.

BACKGOUND Cold snare polypectomy (CSP) can minimize the risk of adverse events and has become a standard treatment for small colorectal polyps. CSP might also be suitable for small superficial non-ampullary duodenal epithelial tumors (SNADETs). This study aimed to evaluate the safety of CSP for SNADETs. METHODS The major indication criteria were as follows: (1) endoscopically diagnosed SNADET, (2) ≤ 10 mm, and (3) a single primary lesion. CSP was performed using an electrosurgical snare without electrocautery. Follow-up endoscopy and scar biopsy were performed 3 months after CSP. The primary endpoint was the delayed adverse events rate. RESULTS In total, 21 patients were enrolled. Two and 19 lesions were located in the duodenal bulb and 2nd portion, respectively; the median lesion size was 8 mm. CSP was attempted for all lesions; three lesions could not be resected without electrocautery and were removed by conventional endoscopic mucosal resection (EMR). The rate of spurting bleeding after CSP was 0%. The median procedure time was 12 min, the median resected specimen size was 12 mm, and the rate of en bloc resection was 81% (17/21). No adverse events were observed intraoperatively, with no delayed adverse events after CSP. Histopathology revealed 15 adenomas, 4 cancers (intramucosal), and 2 non-neoplastic lesions. The horizontal margins were negative/positive/undetermined in 9, 1, and 11 cases, respectively. All vertical margins were negative. Only one recurrence was detected by follow-up endoscopy 3 months after CSP. CONCLUSIONS CSP can be performed safely for small SNADETs. CLINICAL TRIAL REGISTRATION This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry ( http://www.umin.ac.jp/ctr/index.htm ), and the registration number is UMIN000019157.

Extension of adenocarcinoma of the esophagogastric junction under the squamous epithelium may lead to errors when determining lateral margins. However, the characteristics of subsquamous extension are unclear. Herein, we evaluated the prevalence and characteristics of subsquamous extension of adenocarcinoma of the esophagogastric junction and the diagnostic performance of endoscopy for this condition.Eighty-nine consecutive patients with superficial adenocarcinoma of the esophagogastric junction who underwent endoscopic or surgical resection at a tertiary cancer center between January 2010 and December 2017 were retrospectively evaluated. Endoscopic subsquamous extension was defined as a submucosal tumor-like elevation covered by squamous epithelium and/or a brownish area with abnormal microvessels on the squamous epithelium observed using narrow-band imaging. The diagnostic performance of endoscopy for subsquamous extension was evaluated using histological subsquamous extension as gold standard.Thirty-nine patients (44%) had histological subsquamous extension. Proton pump inhibitor use was significantly associated with histological subsquamous extension [odds ratio: 4.65; 95% confidence interval (CI): 1.77-12.2]. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of endoscopic subsquamous extension were 56% (95% CI: 40-72%), 96% (86-99%), 92% (73-99%), 74% (62-84%) and 79% (69-87%), respectively. The median length difference between histological and endoscopic subsquamous extension was 2 mm (range: -6 to 9 mm).The sensitivity of endoscopic diagnosis of subsquamous extension was unsatisfactory. The endoscopic length of subsquamous extension tended to be underestimated. An oral safety margin of one centimeter is reasonable during endoscopic resection of adenocarcinoma of the esophagogastric junction.IMPACT STATEMENT This study will contribute significantly to the literature because this is the first study to determine the difference between the lengths of subsquamous extension detected endoscopically and histologically. This study determines the prevalence of subsquamous extension and identifies characteristics associated with subsquamous extension. An understanding of the risk of subsquamous extension is important when choosing a treatment strategy and planning the resection margins in patients with adenocarcinoma of the esophagogastric junction. This study provides patients with subsquamous extension characteristics and suggests a method for accurately diagnosing this condition.

OBJECTIVES Magnifying endoscopy with narrow-band imaging (M-NBI) is useful for the optical diagnosis of gastrointestinal neoplasms. However, the utility of M-NBI in screening esophagogastroduodenoscopy (EGD) is unclear. We aimed to evaluate the diagnostic ability of the magnification endoscope (ME) in screening EGD for a population with a low prevalence of upper gastrointestinal cancers. METHODS Overall, 4887 asymptomatic examinees without a history of laryngopharyngeal and/or upper gastrointestinal neoplasms who underwent opportunistic screening EGD between April 2011 and December 2017 were enrolled in this retrospective study. The examinees were categorized into two groups depending on whether screening EGD was performed using ME (ME group) or not (non-ME group). Using a propensity score-matched analysis, the diagnostic ability of EGD was compared between the two groups. RESULTS In total, 1482 examinees (30%) were allocated to the ME group and 3405 (70%) to the non-ME group. Thirty-five epithelial neoplasms were detected in 30 examinees (0.6%). The groups were matched for baseline characteristics (1481 pairs). Both groups showed no significant difference in the epithelial neoplasm detection rate (0.8% vs. 0.3%; P = 0.14). The biopsy rate was significantly lower in the ME group than in the non-ME group (12% vs. 15%; P = 0.003). The positive predictive value (PPV) for biopsy was significantly higher in the ME group than in the non-ME group (6.6% vs. 2.8%; P = 0.048). CONCLUSIONS Using an ME for screening EGD in an apparently healthy, asymptomatic population could reduce unnecessary biopsies by improving PPV for biopsy without decreasing the epithelial neoplasm detection rate.

OBJECTIVES Surgery is recommended for early gastric cancer (EGC) beyond the endoscopic resection (ER)-indication for the risk of lymph node metastasis; however, ER may be chosen as a "relative ER-indication" considering age and comorbidities. This study aimed to compare outcomes of endoscopic submucosal dissection (ESD) only and surgery (primary surgery and additional surgery after non-curative ESD) among elderly patients with relative ER-indication EGC and to further assess prognostic factors. METHODS Outcomes of ESD and surgery (417 cases; 114 ESD, 303 surgery) in elderly patients (≥75 years) with relative ER-indication EGC were retrospectively analyzed. Prognostic factors were also examined. RESULTS During the observation period (median; ESD, 34 months; surgery, 61 months), 29% of ESD and 35% of surgery patients died, including 4% and 5% from gastric cancer (GC), respectively. ESD showed lower overall survival (OS) than surgery (P = 0.027) but comparable disease-free survival (P = 0.916). OS-associated factors were age and prognostic nutritional index (PNI) in males (age ≥79, hazard ratio [HR] 2.21, P = 0.001; PNI

Summary Our study aimed to compare the treatment outcomes between endoscopic submucosal dissection (ESD) with an insulated-tip knife (ESD-IT) and a needle-type knife (ESD-N) for large superficial esophageal neoplasms, as no study of this kind has been previously reported. We used the dataset of a multicenter, randomized controlled trial that compared conventional ESD (C-ESD) and traction-assisted ESD (TA-ESD) for superficial esophageal neoplasms. We compared the procedural outcomes between ESD-IT and ESD-N in a post hoc analysis and conducted sub-analyses based on traction assistance and electrical knife type. We included 223 (EST-IT, n = 169; ESD-N, n = 54) patients with no significant differences in baseline characteristics. The operator handover rate due to ESD difficulties was significantly higher in ESD-N (ESD-IT = 0.6% vs. ESD-N = 13.0%, P = 0.001), while the injection volume was significantly higher in ESD-IT than in ESD-N (40.0 vs. 20.5 mL, P 0.99; and complication rate: 1.8% vs. 3.7%, P = 0.60 for ESD-IT and ESD-N, respectively). In the sub-analyses, the handover rate was significantly lower with TA-ESD than with C-ESD for ESD-N (3.2% vs. 26.1%, P = 0.034), and a significantly smaller injection volume was used in TA-ESD than in C-ESD for ESD-IT (31.5 vs. 47.0 mL, P

Introduction One-piece endoscopic mucosal resection (EMR) for lesions >15 mm is still unsatisfactory, and attempted 1-piece EMR for lesions >25 mm can increase perforation risk. Therefore, modifications to ensure 1-piece EMR of 15- to 25-mm lesions would be beneficial. The aim of this study was to investigate whether Tip-in EMR, which anchors the snare tip within the submucosal layer, increases en bloc resection for 15- to 25-mm colorectal lesions compared with EMR. Methods In this prospective randomized controlled trial, patients with nonpolypoid colorectal neoplasms of 15-25 mm in size were recruited and randomly assigned in a 1:1 ratio to undergo Tip-in EMR or standard EMR, stratified by age, sex, tumor size category, and tumor location. The primary endpoint was the odds ratio of en bloc resection adjusted by location and size category. Adverse events and procedure time were also evaluated. Results We analyzed 41 lesions in the Tip-in EMR group and 41 lesions in the EMR group. En bloc resection was achieved in 37 (90.2%) patients undergoing Tip-in EMR and 30 (73.1%) who had EMR. The adjusted odds ratio of en bloc resection in Tip-in EMR vs EMR was 3.46 (95% confidence interval: 1.06-13.6, P = 0.040). The Tip-in EMR and EMR groups did not differ significantly in adverse event rates (0% vs 4.8%) or median procedure times (7 vs 5 minutes). Discussion In this single-center randomized controlled trial, we found that Tip-in EMR significantly improved the en bloc resection rate for nonpolypoid lesions 15-25 mm in size, with no increase in adverse events or procedure time.

The multi-institutional, single-arm, confirmatory trial (JCOG0607) showed excellent efficacy of endoscopic submucosal dissection (ESD) for the expanded indication of intramucosal intestinal-type early gastric cancer (EGC), which consists of two groups; the lesions 2 cm if clinical finding of ulcer (cUL)-negative or those ≤ 3 cm if cUL-positive because of the expected low risk of lymph node metastasis. However, the proportion of non-curative resections (NCR) requiring additional surgery was high (32.4%). This post hoc analysis aimed to explore the clinical factors associated with NCR.As the expanded indication includes two different groups, we explored the clinical factors associated with NCR separately in cUL-negative ( 2 cm) and cUL-positive (≤ 3 cm) groups using the log-linear model.Two hundred sixty cUL-negative and 206 cUL-positive EGCs were analyzed. The proportions of NCR were 33.8% in the cUL-negative group and 29.6% in the cUL-positive group. A multivariable analysis demonstrated that moderately differentiated predominant histology diagnosed in pre-treatment biopsy (risk ratio (RR), 1.93, 95%CI 1.34-2.77, P0.001) and lesion in the upper stomach (RR, 1.75, 95%CI 1.03-2.96, P=0.038) in the cUL-negative EGCs, and tumor size 2 cm (RR, 1.78, 95%CI 1.22-2.58, P=0.003) and female sex (RR, 1.62, 95%CI 1.07-2.44, P=0.021) in the cUL-positive EGCs were independent factors associated with NCR.Clinical risk factors associated with NCR were different between cUL-negative and cUL-positive EGCs. To avoid NCR, we need to take these factors into account when deciding expanded indication for ESD.

A drawback of endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is the development of metachronous gastric cancer (MGC). While MGC after ESD for differentiated-type (D-) EGC was well understood, little is known about MGC occurring after ESD for undifferentiated-type (UD-) EGC, because ESD had not been indicated. We evaluated the incidence and treatment outcomes of MGC after ESD of UD-EGC. This study is a post hoc analysis of JCOG1009/1010, a multicenter trial to evaluate the efficacy and safety of ESD for UD-EGC. The patients who underwent curative ESD of index solitary UD-EGC were analyzed. Surveillance endoscopy was performed biannually for the first 3 years and thereafter annually. We assessed the time to MGC occurrence after ESD, lesion characteristics, and treatment outcomes of MGC. Time to MGC occurrence was estimated by cumulative incidence function, with death and total gastrectomy as competing risks. A total of 198 patients were included in this study. During a median follow-up period of 5.8 years, 4 patients (2%) developed MGC. Median time to MGC occurrence was 4.5 years (range: 3.1–5.4). Five-year cumulative incidence of MGC was 1.0% (95% CI: 0.2–3.3%). Two MGCs were histologically D-EGC, and the remaining two were UD-EGC. The median tumor size of MGCs was 1.0 cm (range: 0.7–1.7), and the depth of invasion (M/SM1/SM2) was 2/1/1, respectively. Three patients achieved curative resection with repeated ESD. MGC does not occur commonly after curative ESD of UD-EGC, and repeated ESD could contribute to stomach preservation.

In endoscopic retrograde cholangiopancreatography (ERCP), reduction of pressure inside of the bile duct by bile aspiration is a well-known method to lower the rate of adverse events (AEs) including cholangitis. Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) has been introduced as an alternative to ERCP. The use of self-expandable metallic stents is recommended in EUS-HGS to reduce bile leak; however, other methods to reduce the rate of AEs including bile leak, abdominal pain, fever, and sepsis, have not been elucidated yet. This study investigated whether bile aspiration during EUS-HGS decreased the rate of postprocedural AEs. Consecutive patients who underwent EUS-HGS between July 2016 and April 2020 were retrospectively evaluated in this study. EUS-HGS was performed at a tertiary cancer center. Patient characteristics, site of biliary obstruction, the quantity of bile aspirated during EUS-HGS, type of stent, whether or not antegrade stenting (AS) was performed, procedure time, and AEs were assessed based on a prospectively recorded institutional endoscopy database. Logistic regression analysis was performed to identify factors affecting postprocedural AEs. Ninety-six patients were included in the study. EUS-guided HGS with and without AS was performed in 45 and 51 patients, respectively. Bile was aspirated in 71 patients (74%). The quantity of bile aspirated was 0–10 mL and > 10 mL in 40 and 56 patients, respectively. AEs including fever, abdominal pain, postprocedural cholangitis, sepsis, acute pancreatitis, and bleeding occurred in 45 patients (47%). The AE rates were 65% (26/40) and 34% (19/56), for 0–10 mL and > 10 mL bile, respectively (p = 0.004). Using multivariate analysis, the only independent factor affecting the occurrence of AEs was found to be an aspirated bile amount of 0–10 mL (odds ratio: 4.16; 95% CI 1.6–10.8). Bile aspiration of more than 10 mL during EUS-HGS contributes to reducing the rate of postprocedural AEs.

Background The optimal extent of lymph node dissection in patients receiving non-curative endoscopic submucosal dissection (ESD) and diagnosed with a positive vertical margin is unclear. This study attempted to identify optimal candidates for D2 lymph node dissection among these patients. Methods This study included patients who underwent gastrectomy for primary gastric cancer following non-curative ESD with a positive vertical margin between January 2002 and December 2018. We classified the patients according to the positive vertical margin pattern into an obvious exposure group and a non-obvious exposure group. We developed a score model for predicting lymph node metastasis (LNM) using factors selected by multivariate analyses and beta regression coefficients, and the incidence of LNM was evaluated. Results This study included 110 patients. LNM was detected in 17 patients (15%). We developed a predictive scoring system as follows: tumor size >30 mm (0, No; 1, Yes) + undifferentiated type tumor in the invasive front (0, No; 2, Yes) + depth of submucosal invasion > 1500 μm (0, No; 1, Yes) + obvious tumor exposure at the vertical margin (0, No; 1, Yes). In patients with 5 points, the incidence rates of all and group 2 LNM were as high as 60% and 40%, respectively. Conversely, in patients with fewer than 5 points, the incidence rates of all and group 2 LNM were just 11% and 5%, respectively. Conclusion In patients with 5 points according to our score model for predicting LNM, gastrectomy with D2 lymph node dissection is recommended.

Background and Aims Cold-snare endoscopic mucosal resection (CS-EMR) has been adapted in a piecemeal fashion as a safe and effective procedure for resection of colorectal polyps ≥10 mm. However, few data are available on en bloc CS-EMR for adenomas of 10 to 14 mm. Thus, this study evaluated the efficacy and safety of CS-EMR for these colorectal adenomas. Methods In this single-arm, prospective, observational study, patients with at least 1 slightly elevated and sessile colorectal adenoma measuring 10 to 14 mm were recruited to undergo CS-EMR. The primary outcome was histological complete resection rate by CS-EMR, which was defined as en bloc resection, with a pathologically negative vertical margin and no neoplastic tissue obtained from 4 quadrants of the mucosal defect margin. Secondary outcomes were en bloc resection rate by CS-EMR, failure rate of CS-EMR, and the incidence of adverse events. Results A total of 80 polyps from 72 patients were included. CS-EMR failed in 11 lesions (13.7%), all of which were resected using a high-frequency electric current. The rates of en bloc resection and histologic complete resection by CS-EMR were 82.5% (66 of 80) and 63.8% (51 of 80), respectively. No bleeding occurred during the CS-EMR procedure, and there was no delayed bleeding or perforation at the site where CS-EMR was performed. Conclusions CS-EMR can be safely performed in an en bloc fashion for some colorectal adenomas measuring 10 to 14 mm. However, there is room for improvement regarding the resectability and evaluation of the vertical margin after CS-EMR. (Clinical trial registration number: UMIN000031248.)

We aimed to clarify the long-term outcomes of endoscopic resection (ER) for early gastric cancers (EGCs) based on pathological curability in a multicenter prospective cohort study.We analyzed the long-term outcomes of 9054 patients with 10,021 EGCs undergoing ER between July 2010 and June 2012. Primary endpoint was the 5-year overall survival (OS). The hazard ratio for all-cause mortality was calculated using the Cox proportional hazards model. We also compared the 5-year OS with the expected one calculated for the surgically resected patients with EGC. If the lower limit of the 95% confidence interval (CI) of the 5-year OS exceeded the expected 5-year OS minus a margin of 5% (threshold 5-year OS), ER was considered to be effective. Pathological curability was categorized into en bloc resection, negative margins, and negative lymphovascular invasion: differentiated-type, pT1a, ulcer negative, ≤2 cm (Category A1); differentiated-type, pT1a, ulcer negative,2 cm or ulcer positive, ≤3 cm (Category A2); undifferentiated-type, pT1a, ulcer negative, ≤2 cm (Category A3); differentiated-type, pT1b (SM1), ≤3 cm (Category B); or noncurative resections (Category C).Overall, the 5-year OS was 89.0% (95% CI, 88.3%-89.6%). In a multivariate analysis, no significant differences were observed when the hazard ratio of Categories A2, A3, and B were compared with that of A1. In all the pathological curability categories, the lower limit of the 95% CI for the 5-year OS exceeded the threshold 5-year OS.ER can be recommended as a standard treatment for patients with EGCs fulfilling Category A2, A3, and B, as well as A1 (UMIN Clinical Trial Registry, UMIN000005871).

Background Metallic stents placed in the descending duodenum can cause compression of the major duodenal papilla, resulting in acute cholangitis and pancreatitis. These are notable early adverse events of duodenal stent placement; however, they have been rarely examined. This study aimed to assess the incidence of and risk factors for acute cholangitis and/or pancreatitis after duodenal stent placement in the descending duodenum. Methods We retrospectively reviewed data of consecutive patients who underwent metallic stent placement in the descending duodenum for malignant gastric outlet obstruction at a tertiary referral cancer center between April 2014 and December 2019. Risk factors for acute cholangitis and/or pancreatitis were analyzed using a logistic regression model. Results Sixty-five patients were included. Acute cholangitis and/or pancreatitis occurred in 11 patients (17%): seven with cholangitis, two with pancreatitis, and two with both cholangitis and pancreatitis. Multivariate analysis indicated that female sex (odds ratio: 9.2, 95% confidence interval: 1.4–58.6, P = 0.02), absence of biliary stents (odds ratio: 12.9, 95% confidence interval: 1.8–90.2, P = 0.01), and tumor invasion to the major duodenal papilla (odds ratio: 25.8, 95% confidence interval: 2.0–340.0, P = 0.01) were significant independent risk factors for acute cholangitis and/or pancreatitis. Conclusions The incidence of cholangitis and/or pancreatitis after duodenal stent placement in the descending duodenum was non-negligible. Female sex, absence of biliary stents, and tumor invasion to the major duodenal papilla were the primary risk factors. Risk stratification can allow endoscopists to better identify patients at significant risk and permit detailed informed consent.

BACKGROUND AND AIM Fragmentation of endoscopically resected colorectal polyps during retrieval is one of the limitations for appropriate pathological diagnosis; however, little is known about steps to reduce it. We aimed to evaluate the effect of removing the suction valve button, which is one of the intricate parts of the endoscope, during polyp suction retrieval for fragmentation and pathological diagnosis. METHODS We retrospectively reviewed the polyps retrieved by suctioning. We used the propensity score matching method to adjust for difference between the button-attached and button-removed groups. Outcomes of fragmentation, pathological diagnosis of non-neoplastic polypectomy (NNP), and pathological cut-end among neoplastic lesions were evaluated. RESULTS On the basis of propensity score matching, 322 pairs of cases were selected for analysis. After matching, the difference in the variables between the two groups was closely balanced. The fragmentation rate was significantly different between the groups (button-attached 36.6% vs. button-removed 22.4%, P

BACKGROUND Magnifying narrow-band imaging (M-NBI) and magnifying chromoendoscopy (M-CE) enable accurate diagnosis of T1 colorectal cancer, but the diagnostic yields from combined M-NBI and CE have not been fully analyzed. We aimed to evaluate the diagnostic yield of combining Japan NBI Expert Team (JNET) classification using M-NBI and M-CE. METHODS Superficial colorectal lesions ≥10 mm removed at a Japanese tertiary cancer center between February 2016 and December 2018 were included. We analyzed the relationship between JNET classification, M-CE findings, and histological results based on prospectively collected endoscopic and pathologic data. RESULTS A total of 1573 lesions, including 56 superficial submucosal invasive cancers, 160 deep submucosal invasive cancers, and 81 advanced cancers (≥T2) were analyzed. The probability of deeply invasive cancer (95% confidence interval) was 1.8% (1.1-2.8), 30.1% (25.4-35.1), and 96.6% (91.5-99.1) in JNET Types 2A, 2B, and 3, respectively. The probability of deeply invasive cancer in JNET Type 2B lesions with non-V, VL, and VH pit pattern was 4.3%, 16.6%, 76.0%, respectively (P

Background Prospectively collected long-term data of patients undergoing endoscopic resection for superficial esophageal squamous cell carcinoma (ESCC) are limited. The aim of this study was to determine the prospectively collected long-term outcomes of endoscopic resection for ESCC as a secondary analysis of the Japan Esophageal Cohort (JEC) study. Methods Patients who underwent endoscopic resection of intramucosal ESCC at 16 institutions between September 2005 and May 2010 were enrolled in the JEC study. All patients underwent endoscopic examination with iodine staining at 3 and 6 months after resection, and every 6 months thereafter. We investigated clinical courses after endoscopic resection, survival rates, and cumulative incidence of metachronous ESCC. Results 330 patients (mean age 67.0 years) with 396 lesions (mean size 20.4 mm) were included in the analysis. Lesions were diagnosed as high-grade intraepithelial neoplasia in 17.4 % and as squamous cell carcinoma in 82.6 % (limited to epithelium in 28.4 %, to lamina propria in 55.4 %, and to muscularis mucosa in 16.2 %). En bloc resection was achieved in 291 (73.5 %). The median follow-up period was 49.4 months. Local recurrences occurred in 13 patients (3.9 %) and were treated by endoscopic procedures. Lymph node metastasis occurred in two patients (0.6 %) after endoscopic resection. The 5-year overall, disease-specific, and metastasis-free survival rates were 95.1 %, 99.1 %, and 94.6 %, respectively. The 5-year cumulative incidence rate of metachronous ESCC was 25.7 %. Conclusions Our study demonstrated that endoscopic resection is an effective treatment for intramucosal ESCC, with favorable long-term outcomes.

OBJECTIVES Technical difficulties in colorectal endoscopic submucosal dissections (ESD) result in en bloc resection failure or perforation. This study aimed to develop and validate a risk score for predicting en bloc resection failure or perforation in ESD of colorectal neoplasms. METHODS This single-center observational study included 1133 colorectal neoplasms treated with ESD in a Japanese tertiary cancer center. With a derivation set (n = 716), we performed multiple logistic regression to identify significant risk factors for en bloc resection failure or perforation. Based on odds ratios, we developed a risk score, ranging from 0 to 10: 0-1 'low risk' (LR); 2-4 'moderate risk' (MR); and 5-10 'high risk' (HR). An independent validation set comprised prospectively enrolled subjects (n = 417) that underwent ESDs from January 2014 to August 2016. The performance of the risk score for predicting en bloc resection failure or perforation for each risk tier was evaluated. RESULTS The baseline incidences of en bloc resection failure or perforation were 14.5% and 5.5% in the derivation and validation sets, respectively. We identified the following significant risk factors: endoscopist experience, tumor location, morphology, scope operability, underlying fold, and fold convergence. In the validation set, the incidences of en bloc resection failure or perforation were 0% in the LR tier (n = 62; 14.8%), 2.3% in the MR tier (n = 293; 70.4%), and 25.8% in the HR tier (n = 62; 14.8%) (P < 0.001, Cochran-Armitage trend test). CONCLUSIONS A risk scoring system, which was developed and prospectively validated, can successfully estimate the incidence of en bloc resection failure or perforation.

Background and Aims: Surgery is recommended in early gastric cancer (EGC) after noncurative endoscopic submucosal dissection (ESD), although observation can be an alternative. We aimed to develop a tailor-made treatment strategy for noncurative EGCs by comparing the lymph node metastasis risk (LNMR) and the surgical risk. Methods: We retrospectively identified 485 patients with differentiated-type, noncurative EGCs removed by ESD and classified them into two groups: a surgery-preferable group and an observation-preferable group, according to the clinical courses. Subsequently, LNMR and surgery-related death risk were assessed using a published scoring system and a risk calculator for gastrectomy, respectively. Finally, we investigated the optimal cutoff value of the risk difference (LNMR minus surgery-related death risk) to efficiently allocate these cases into either of two groups, surgery-preferable or observation-preferable. Results: In 485 patients (surgery in 322, observation in 163), 57 and 428 patients were classified into the surgery-preferable group and the observation-preferable group, respectively. The optimal cutoff value of the risk difference (LNMR minus surgery-related death risk) to allocate the cases to the two preferable groups was 7.85 with the highest area under the curve (0.689). When cases with >7.85 LNMR over the surgery-related death risk were allocated into the surgery-preferable group and vice versa, the discriminability was 73.2%, which was sufficiently higher than that in the clinical decision (44.5%). Conclusion: Personalized comparison of LNMR and surgery-related death risk is helpful to provide a favorable treatment option for each patient with EGCs after noncurative ESD.

Background and aim It is imperative to distinguish superficial non-ampullary duodenal carcinomas (NADCs) between intramucosal and submucosal invasive carcinoma for treatment selection. The aim of this study was to evaluate the clinicopathological differences of intramucosal and submucosal carcinoma. Methods This was a retrospective, single-center study comprising 134 patients with 137 superficial NADCs during May 2005 and March 2018. Clinicopathological characteristics and treatment outcomes data were used to perform a comparative analysis of endoscopic findings, preoperative diagnoses of depth of cancer, and treatment outcomes of histologically diagnosed intramucosal and submucosal carcinoma. Results Of the 137 NADCs, 125 (91%) were intramucosal, and 12 (9%) were submucosal. The proportion of submucosal carcinoma was significantly higher on the oral side of the papilla than on the anal side (16% vs 1%, P = 0.002). Submucosal tumor-like appearance was more frequent in submucosal than in intramucosal carcinoma (58% vs 13%, P = 0.001). There was no significant difference in tumor diameter between the groups, but 33% of submucosal carcinomas were ≤ 10 mm. Correct preoperative diagnosis of depth was achieved in 33% of submucosal carcinoma. Submucosal carcinoma was frequently underestimated when tumor diameters were ≤ 10 mm. Conversely, intramucosal carcinoma was frequently overestimated when the tumor was ≥ 30 mm and had thickness or giant nodules. Lymph node metastasis was found in one submucosal carcinoma patient. Conclusions The possibility of submucosal invasion should be considered when NADCs are located on the oral side of the papilla or have submucosal tumor-like appearance even if tumor diameters are ≤ 10 mm.

Patients with early esophageal squamous cell carcinoma (ESCC) may develop multiple second primary ESCC and cancers in other organs even after curative endoscopic resection (ER). We investigated whether administration of chemoradiotherapy (CRT) after ER decreases the incidence of second primary cancers.We conducted a post hoc analysis of the prospective study. Among the registered 170 patients with clinical submucosal ESCC, 74 underwent ER alone, and 96 underwent ER followed by CRT (ER + CRT) because of pathological results of submucosal or lympho-vascular invasion. We compared the incidence of second primary cancers in esophagus and in other organs between two treatment groups. A univariate analysis was performed to investigate the related risk factors. All patients were followed up with esophagogastroduodenoscopy and CT every 4 months for the first 3 years and every 6 months thereafter.Sixty-one ESCC were detected in 32 patients, and the 3-year cumulative incidence of multiple ESCCs was not different between ER + CRT and ER alone (10.4% vs. 13.5%). Sixty-three second primary cancers in other organs were detected in 45 patients, and there was no difference in the cumulative incidence between two groups. The risk factors for multiple ESCCs were high alcohol consumption and grade C multiple Lugol-voiding lesions. Heavy drinker or patients with grade C multiple Lugol-voiding lesion rather than CRT were at risk for second primary ESCC.CRT after ER did not decrease the cumulative incidence of second primary ESCC nor cancers in other organs comparing with ER alone.

Endoscopic submucosal dissection (ESD) has become popular, but complications such as postoperative bleeding remain an issue. Although some methods of closing a mucosal defect with a snare and clips have been reported to be effective and safe, the snare is not a dedicated device, and the procedure is difficult and time-consuming. We aimed to find an alternative method for defect closure after ESD by developing a dedicated device.We have improved five prototypes. The load on the stopper when starting to tighten and loosen a loop and the maximum load on the stopper and the movement distance of the thread when sliding the stopper were measured five times for each prototype. With the 5th prototype, we finalized the design and named it FLEXLOOP. Additionally, the material and shape of the outer tube were improved. Then, the usability of FLEXLOOP was evaluated in pigs. The operation time for closing mucosal defects with the snare or FLEXLOOP was measured five times.We made FLEXLOOP, which had a lower load when sliding and a higher load when loosening than the snare. The improvement of the outer tube significantly reduced the load on the sheath when sliding it. We confirmed the feasibility of mucosal defect closure with FLEXLOOP in pigs. The median operation time was 563 s (range 340-679 s) with the snare and 355 s (range 303-455 s) with FLEXLOOP (FLEXLOOP can be a promising option for defect closure after ESD.

Tip-in EMR, which includes anchoring the snare tip, has recently shown a favorable en-bloc and R0 resection rate for colorectal neoplasms. Thus, Tip-in EMR may be an alternative to endoscopic submucosal dissection (ESD). We aimed to compare clinical outcomes between Tip-in EMR and ESD for large colorectal neoplasms.This retrospective study evaluated consecutive patients who underwent Tip-in EMR or ESD for 20- to 30-mm nonpedunculated colorectal neoplasms at a Japanese tertiary cancer center between January 2014 and December 2019. Baseline characteristics, treatment results, and long-term outcomes were analyzed using 1:1 propensity score matching.Seven hundred nine lesions were evaluated. The Tip-in EMR group included 1 lesion with a nonlifting sign but no lesions with fold convergence. After propensity score matching, each group included 140 lesions. The ESD group showed significantly higher en-bloc resection rates (99.3% vs 85.0%) and R0 resection rates (90.7% vs 62.9%). Procedure time was significantly shorter in the Tip-in EMR group (8 minutes vs 60 minutes). The Tip-in EMR and ESD groups did not differ significantly with respect to local recurrence rate (2.1% vs 0%).Tip-in EMR is comparable with ESD with respect to the local recurrence rate but has a shorter procedure time, despite the lower en-bloc and R0 resection rates for 20- to 30-mm nonpedunculated colorectal neoplasms without fold convergence or nonlifting sign. Thus, Tip-in EMR could be a feasible alternative to ESD in these lesions.

BACKGROUND AND AIM Preoperative determination of the invasion depth of superficial adenocarcinoma of the esophagogastric junction is important for appropriate endoscopic or surgical resection. There are no objective criteria regarding this; therefore, we investigated the factors associated with the invasion depth of superficial adenocarcinoma of the esophagogastric junction. METHODS This retrospective study evaluated patients with superficial adenocarcinoma of the esophagogastric junction who had undergone endoscopic or surgical resection at a Japanese tertiary cancer center between April 2004 and December 2017. We analyzed endoscopic features of intramucosal to slight submucosal (M-SM1; < 500 μm) and deep submucosal (SM2; ≥500 μm) adenocarcinoma of the esophagogastric junction and extracted significant factors associated with and assessed the diagnostic performance of endoscopic features for SM2 lesion. RESULTS A total of 106 cases were included in this study. Multivariate analysis indicated that depressed or protruded type (odds ratio [OR], 11.1), lesion size ≥15 mm (OR, 3.11), uneven surface (OR, 6.31), and subsquamous extension (OR, 5.41) were significantly associated with SM2 adenocarcinomas of the esophagogastric junction. When the macroscopic type was depressed or protruded, high sensitivity (97%) but fair specificity (46%) were observed for SM2 adenocarcinoma of the esophagogastric junction, whereas uneven surface and subsquamous extension showed high specificity (96% and 87%) but fair sensitivity (36% and 46%). CONCLUSIONS Depressed or protruded type, lesion size ≥15 mm, uneven surface, and subsquamous extension were significantly associated with the invasion depth of superficial adenocarcinoma of the esophagogastric junction. These endoscopic features are useful in determining the treatment modality preoperatively.

Key Points Question Is the performance of endoscopic ultrasonography after conventional endoscopy associated with improvements in diagnosing the invasion depth of esophageal squamous cell carcinoma? Findings In this diagnostic study of 372 patients with esophageal cancer, the performance of endoscopic ultrasonography after nonmagnifying and magnifying endoscopy was not associated with improvements in diagnostic performance for differentiating between submucosal and mucosal cancers in terms of overdiagnosis and accuracy. Meaning This study suggests that endoscopic ultrasonography after nonmagnifying and magnifying endoscopy is not helpful for evaluating the invasion depth of T1 esophageal squamous cell carcinoma., Importance Distinguishing between mucosal and submucosal cancers is important for selecting the optimal treatment for patients with esophageal squamous cell carcinoma (ESCC); however, standard procedures for diagnosing cancer invasion depth have not yet been determined. Objective To evaluate the diagnostic performance of endoscopic ultrasonography (EUS) after conventional endoscopy for the evaluation of ESCC invasion depth. Design, Setting, and Participants This prospective single-arm confirmatory diagnostic study comprising 372 patients with T1 esophageal cancer was conducted at 41 secondary or tertiary hospitals in Japan. Enrollment began on July 20, 2017; patients were enrolled in 2 steps, with the first registration occurring from August 4, 2017, to December 11, 2019, and the second from August 9, 2017, to December 11, 2019. After the completion of all first and second registration examinations, patients received treatment and were followed up for 30 days, with follow-up ending on February 14, 2020. Patients were eligible for inclusion if they had pathologically or endoscopically diagnosed esophageal cancer with T1 clinical depth of invasion. Interventions In the first registration, nonmagnifying endoscopy (non-ME) and magnifying endoscopy (ME) were used to diagnose cancer invasion depth. In the second registration, patients from the first registration who had cancers invading the muscularis mucosa or submucosa were enrolled and received EUS. After completion of the protocol examinations, patients received treatment with endoscopic resection or esophagectomy. The pathological results of the resected specimens were used as the reference standard for evaluating cancer invasion depth. Main Outcomes and Measures The primary end point was the proportion of overdiagnosis of submucosal cancer (defined as invasion depth >200 μm) after receipt of non-ME and ME, with or without the addition of EUS. The secondary end points were underdiagnosis, sensitivity, and specificity. Results Among 372 patients enrolled in the first registration, 371 received non-ME and ME. Of those, 300 patients were enrolled in the second registration, and 293 patients received EUS. A total of 269 patients (217 men [80.7%]; median age, 69 years; interquartile range, 62-75 years) were included in the final analysis. The addition of EUS was associated with a 6.6% increase in the proportion of overdiagnosis (from 16 of 74 patients [21.6%; 95% CI, 12.9%-32.7%] after non-ME and ME to 29 of 103 patients [28.2%; 95% CI, 19.7%-37.9%] after the addition of EUS; 1-sided P = .93). All subgroup analyses found similar increases in overdiagnosis of submucosal cancer. The addition of EUS was associated with a 4.5% reduction in the proportion of underdiagnosis (from 57 of 195 patients [29.2%; 95% CI, 23.0%-36.2%] after non-ME and ME to 41 of 166 patients [24.7%; 95% CI, 18.3%-32.0%] after the addition of EUS). After non-ME and ME, diagnostic sensitivity was 50.4% (95% CI, 41.0%-59.9%), specificity was 89.6% (95% CI, 83.7%-93.9%), and accuracy was 72.9% (95% CI, 67.1%-78.1%). After the addition of EUS, diagnostic sensitivity was 64.3% (95% CI, 54.9%-73.1%), specificity was 81.2% (95% CI, 74.1%-87.0%), and accuracy was 74.0% (95% CI, 68.3%-79.1%). Conclusions and Relevance This study found that the addition of EUS was not associated with improvements in the diagnostic accuracy of cancer invasion depth. These findings do not support the routine use of EUS after conventional endoscopy for evaluating the invasion depth among patients with T1 ESCC., This study assesses the performance of endoscopic ultrasonography after nonmagnifying and magnifying endoscopy for the diagnosis of cancer invasion depth among patients with esophageal squamous cell carcinoma.

OBJECTIVES Given the high risk of bleeding in post-endoscopic submucosal dissection (ESD) patients receiving antithrombotic therapy, a new effective method is needed to prevent delayed bleeding among such patients. The aim of this study was to assess the efficacy of endoloop closure, using an endoloop and clips, after gastric ESD to prevent bleeding among patients receiving antithrombotic therapy. METHODS This retrospective study enrolled patients taking antithrombotic agents who underwent ESD for early gastric cancer between March 2016 and January 2019. Patients were classified into two groups: the endoloop closure group and the control group (no prophylactic treatment). We compared the rates of post-endoscopic submucosal dissection bleeding between the two groups. RESULTS Overall, 178 patients were included, with 37 patients in the endoloop closure group and 141 patients in the control group. The rate of post-endoscopic submucosal dissection bleeding was in general lower in the endoloop closure group than in the control group; however, the difference was not statistically significant (8% vs. 23%, p = 0.06). Among patients with a resected specimen size

OBJECTIVES Gastrointestinal (GI) perforations are one of the major adverse events of endoscopic procedures. Polyglycolic acid (PGA) sheets with fibrin glue have been reported to close GI perforations. However, its clinical outcome has not yet been fully investigated; thus, we conducted a multicenter retrospective observational study to assess the efficacy of PGA sheeting for GI perforation. METHODS The medical records of patients who underwent PGA sheeting for endoscopic GI perforations between April 2013 and March 2018 in 18 Japanese institutions were retrospectively analyzed. PGA sheeting was applied when the clip closure was challenging or failed to use. Perforations were filled with one or several pieces of PGA sheets followed by fibrin glue application through an endoscopic catheter. Nasal or percutaneous drainage and endoscopic clipping were applied as appropriate. Clinical outcomes after PGA sheeting for intraoperative or delayed perforations were separately evaluated. RESULTS There were 66 intraoperative and 24 delayed perforation cases. In intraoperative cases, successful closure was attained in 60 cases (91%). The median period from the first sheeting to diet resumption was 6 days (interquartile range [IQR], 4-8.8 days). Large perforation size (≥ 10 mm) and duodenal location showed marginal significant relationship to higher closure failure of intraoperative perforations. In delayed perforation cases, all cases had successful closure. The median period from the first sheeting to diet resumption was 10 days (IQR, 6-37.8 days). No adverse events related to PGA sheeting occurred. CONCLUSION Endoscopic PGA sheeting could be a therapeutic option for GI perforations related to GI endoscopic procedures.