Comparison of Effective Imaging Modalities for Detecting Gastric Neoplasms: A Randomized 3-Arm Phase II Trial.

INTRODUCTION: The early detection of gastric neoplasms (GNs) leads to favorable treatment outcomes. The latest endoscopic system, EVIS X1, includes third-generation narrow-band imaging (3G-NBI), texture and color enhancement imaging (TXI), and high-definition white-light imaging (WLI). Therefore, this randomized phase II trial aimed to identify the most promising imaging modality for GN detection using 3G-NBI and TXI. METHODS: Patients with scheduled surveillance endoscopy after a history of esophageal cancer or GN or preoperative endoscopy for known esophageal cancer or GN were randomly assigned to the 3G-NBI, TXI, or WLI groups. Endoscopic observations were performed to detect new GN lesions, and all suspected lesions were biopsied. The primary endpoint was the GN detection rate during primary observation. Secondary endpoints were the rate of missed GNs, early gastric cancer detection rate, and positive predictive value for a GN diagnosis. The decision rule had a higher GN detection rate between 3G-NBI and TXI, outperforming WLI by >1.0%. RESULTS: Finally, 901 patients were enrolled and assigned to the 3G-NBI, TXI, and WLI groups (300, 300, and 301 patients, respectively). GN detection rates in the 3G-NBI, TXI, and WLI groups were 7.3, 5.0, and 5.6%, respectively. The rates of missed GNs were 1.0, 0.7, and 1.0%, the detection rates of early gastric cancer were 5.7, 4.0, and 5.6%, and the positive predictive values for the diagnosis of GN were 36.5, 21.3, and 36.8% in the 3G-NBI, TXI, and WLI groups, respectively. DISCUSSION: Compared with TXI and WLI, 3G-NBI is a more promising modality for GN detection.

Advanced diagnostic endoscopy in the upper gastrointestinal tract: Review of the Japan Gastroenterological Endoscopic Society core sessions.

The Japan Gastroenterological Endoscopy Society (JGES) held four serial symposia between 2021 and 2022 on state-of-the-art issues related to advanced diagnostic endoscopy of the upper gastrointestinal tract. This review summarizes the four core sessions and presents them as a conference report. Eleven studies were discussed in the 101st JGES Core Session, which addressed the challenges and prospects of upper gastroenterological endoscopy. Ten studies were also explored in the 102nd JGES Core Session on advanced upper gastrointestinal endoscopic diagnosis for decision-making regarding therapeutic strategies. Moreover, eight studies were presented during the 103rd JGES Core Session on the development and evaluation of endoscopic artificial intelligence in the field of upper gastrointestinal endoscopy. Twelve studies were also discussed in the 104th JGES Core Session, which focused on the evidence and new developments related to the upper gastrointestinal tract. The endoscopic diagnosis of upper gastrointestinal diseases using image-enhanced endoscopy and AI is one of the most recent topics and has received considerable attention. These four core sessions enabled us to grasp the current state-of-the-art in upper gastrointestinal endoscopic diagnostics and identify future challenges. Based on these studies, we hope that an endoscopic diagnostic system useful in clinical practice is established for each field of upper gastrointestinal endoscopy.

Efficacy of endoscopic submucosal resection with a ligation device for small rectal neuroendocrine tumor: study protocol of a multicenter open-label randomized control trial (BANDIT trial).

BACKGROUND: Endoscopic resection is widely accepted as a local treatment for rectal neuroendocrine tumors sized ≤ 10 mm. However, there is no consensus on the best method for the endoscopic resection of rectal neuroendocrine tumors. As a simplified endoscopic procedure, endoscopic submucosal resection with a ligation device (ESMR-L) indicates a histologically complete resection rate comparable to that of endoscopic submucosal dissection (ESD). We hypothesized that ESMR-L than ESD would be preferred for rectal neuroendocrine tumors. Hence, this trial aimed to verify whether ESMR-L is non-inferior to ESD in terms of histologically complete resection rate. METHODS: This is a prospective, open-label, multicenter, non-inferiority, randomized controlled trial of two parallel groups, conducted at the Shizuoka Cancer Center and 31 other institutions in Japan. Patients with a lesion endoscopically diagnosed as a rectal neuroendocrine tumor ≤ 10 mm are eligible for inclusion. A total of 266 patients will be recruited and randomized to undergo either ESD or ESMR-L. The primary endpoint is the rate of en bloc resection with histologically tumor-free margins (R0 resection). Secondary endpoints include en bloc resection rate, procedure time, adverse events, hospitalization days, total devices and agents cost, adverse event rate between groups with and without resection site closure, outcomes between expert and non-expert endoscopists, and factors associated with R0 resection failure. The sample size is determined based on the assumption that the R0 resection rate will be 95.2% in the ESD group and 95.3% in the ESMR-L group, with a non-inferiority margin of 8%. With a one-sided significance level of 0.05 and a power of 80%, 226 participants are required. Assuming a dropout rate of 15%, 266 patients will be included in this study. DISCUSSION: This is the first multicenter randomized controlled trial comparing ESD and ESMR-L for the R0 resection of rectal neuroendocrine tumors ≤ 10 mm. This will provide valuable information for standardizing endoscopic resection methods for rectal neuroendocrine tumors. TRIAL REGISTRATION: Japan Registry of Clinical Trials, jRCTs042210124. Registered on Jan 6, 2022.

Results of the interim analysis of a prospective, multicenter, observational study of small subepithelial lesions in the stomach.

OBJECTIVES: Long-term outcomes of gastric subepithelial lesions have not been elucidated. To reveal the natural history, we initiated a prospective, 10-year follow-up of patients with small (≤20 mm) gastric subepithelial lesions in September 2014. Here, we report the results of an interim analysis of a prospective observational study. METHODS: In total, 567 patients with 610 lesions were prospectively registered between September 2014 and August 2016. The location, size, morphology, and number of subepithelial lesions were recorded on a web-based case report form. This study has been conducted as an Academic Committee Working Group of the Japan Gastroenterological Endoscopy Society. RESULTS: The endoscopic follow-up period was 4.60 ± 1.73 years (mean ± standard deviation), and survival data were investigated for 5.28 ± 1.68 years. This interim analysis revealed that the estimated cumulative incidence of a size increase ≥5 mm, after accounting for patients' death and resection of the tumor as competing risk events, was 4.5% at 5 years. In addition, the estimated cumulative incidence of lesion size increase ≥5 mm or resection of lesions was 7.9% at 5 years, and that of size increase ≥10 mm or resection of lesions was 4.5% at 5 years. CONCLUSION: These results indicate that approximately one in 13 patients with small (≤20 mm) gastric subepithelial lesions may require resection or further investigation for increased tumor size (≥5 mm) within 5 years.

Clinical Guidelines for Diagnosis and Management of Cowden Syndrome/PTEN Hamartoma Tumor Syndrome in Children and Adults-Secondary Publication.

Cowden syndrome (CS)/PTEN hamartoma tumor syndrome (PHTS) is a rare autosomal dominantly inherited condition caused by germline pathogenesis. It is associated with multiple hamartomatous lesions occurring in various organs and tissues, including the gastrointestinal tract, skin, mucous membranes, breast, thyroid, endometrium, and brain. Macrocephaly or multiple characteristic mucocutaneous lesions commonly develop in individuals in their 20s. This syndrome is occasionally diagnosed in childhood due to the occurrence of multiple gastrointestinal polyps, autism spectrum disorders, and intellectual disability. CS/PHTS can be diagnosed taking the opportunity of multigene panel testing in patients with cancer. Appropriate surveillance for early diagnosis of associated cancers is required because patients have a high risk of cancers including breast, thyroid, colorectal, endometrial, and renal cancers. Under these circumstances, there is growing concern regarding the management of CS/PHTS in Japan, but there are no available practice guidelines. To address this situation, the guideline committee, which included specialists from multiple academic societies, was organized by the Research Group on Rare and Intractable Diseases granted by the Ministry of Health, Labour, and Welfare, Japan. The present clinical guidelines explain the principles in the diagnosis and management of CS/PHTS, together with four clinical questions and the corresponding recommendations, incorporating the concept of the Grading of Recommendations Assessment, Development, and Evaluation system. Herein, we present an English version of the guideline, some of which have been updated, to promote seamless implementation of accurate diagnosis and appropriate management of pediatric, adolescent, and adult patients with CS/PHTS.

E-learning system to improve the endoscopic diagnosis of early gastric cancer.

We developed three e-learning systems for endoscopists to acquire the necessary skills to improve the diagnosis of early gastric cancer (EGC) and demonstrated their usefulness using randomized controlled trials. The subjects of the three e-learning systems were "detection," "characterization," and "preoperative assessment." The contents of each e-learning system included "technique," "knowledge," and "obtaining experience." All e-learning systems proved useful for endoscopists to learn how to diagnose EGC. Lecture videos describing "the technique" and "the knowledge" can be beneficial. In addition, repeating 100 self-study cases allows learners to gain "experience" and improve their diagnostic skills further. Web-based e-learning systems have more advantages than other teaching methods because the number of participants is unlimited. Histopathological diagnosis is the gold standard for the diagnosis of gastric cancer. Therefore, we developed a comprehensive diagnostic algorithm to standardize the histopathological diagnosis of gastric cancer. Once we have successfully shown that this algorithm is helpful for the accurate histopathological diagnosis of cancer, we will complete a series of e-learning systems designed to assess EGC accurately.

Risk factors for the development of second primary esophageal squamous-cell carcinoma after endoscopic resection for esophageal squamous-cell carcinoma according to genetic polymorphisms related to alcohol and nicotine metabolism.

BACKGROUND: Multiple development of esophageal squamous-cell carcinoma is explained by field cancerization and is associated with alcohol consumption and smoking. We investigated the association between the development of second primary esophageal squamous-cell carcinoma after endoscopic resection for esophageal squamous-cell carcinoma and genetic polymorphisms related to alcohol and nicotine metabolism. METHODS: The study group comprised 56 patients with esophageal squamous-cell carcinoma after endoscopic resection. The main variables were the following: (i) cumulative incidence and total number of second primary esophageal squamous-cell carcinoma according to genetic polymorphisms in alcohol dehydrogenase 1B, aldehyde dehydrogenase 2 and cytochrome P450 2A6; and (ii) risk factors of second primary esophageal squamous-cell carcinoma identified using a multivariate Cox proportional-hazards model. The frequencies of alcohol dehydrogenase 1B, aldehyde dehydrogenase 2 and cytochrome P450 2A6 genetic polymorphisms in the buccal mucosa were analyzed. RESULTS: The median follow-up was 92.8 months (range: 2.7-134.2). Slow-metabolizing alcohol dehydrogenase 1B was associated with a higher 7-year cumulative incidence of second primary esophageal squamous-cell carcinoma (fast-metabolizing alcohol dehydrogenase 1B vs slow-metabolizing alcohol dehydrogenase 1B: 20.5% vs 71.4%, P = 0.006). Slow-metabolizing alcohol dehydrogenase 1B (relative risk [95% confidence interval]: 3.17 [1.49-6.73]), inactive aldehyde dehydrogenase 2 (2.17 [1.01-4.63]) and poorly-metabolizing cytochrome P450 2A6 (4.63 [1.74-12.33]) had a significantly higher total number of second primary esophageal squamous-cell carcinoma per 100 person-years. In the multivariate Cox proportional-hazards model, slow-metabolizing alcohol dehydrogenase 1B was a significant risk factor of the development of second primary esophageal squamous-cell carcinoma (hazard ratio 9.92, 95% confidence interval: 2.35-41.98, P = 0.0018). CONCLUSIONS: Slow-metabolizing alcohol dehydrogenase 1B may be a significant risk factor for the development of second primary esophageal squamous-cell carcinoma. In addition, inactive aldehyde dehydrogenase 2 and poorly-metabolizing cytochrome P450 2A6 may be important factors.

Metachronous primary gastric cancer after endoscopic resection in patients with esophageal squamous cell carcinoma.

BACKGROUND: This study aimed to evaluate the risk factors for developing metachronous primary Gastric Cancer (GC) after Endoscopic Resection (ER) for esophageal Squamous Cell Carcinoma (SCC). METHODS: We studied 283 patients with esophageal SCC who underwent ER. The study outcomes were as follows: (1) incidence of metachronous primary GC after ER; and (2) predictors for the development of metachronous primary GC after ER by the Cox proportional hazards model. RESULTS: The median follow-up was 43.1 months (1.81-79.1), and the 3-year cumulative incidence of metachronous primary GC was 6.5% (95%CI: 4.1-10.4). The incidence of metachronous primary GC during the follow-up period was 2.31 per 100 person-years. The frequencies of severe gastric atrophy and macrocytosis at the timing of ER were significantly higher in patients with than without metachronous primary GC (91.7% vs. 73.2%, p = 0.0422, 20.8% vs. 5.2%, p = 0.0046, respectively). Severe gastric atrophy was associated with the development of metachronous primary GC (sex-and-age adjusted hazard ratio (HR) [95%CI] = 4.12 [0.95-27.78], p = 0.0093). Macrocytosis was associated with the development of metachronous primary GC (sex-and-age adjusted HR = 4.76 [1.75-13.0], p = 0.0012) and found to be an independent predictor for metachronous primary GC by multivariate Cox proportional hazards analysis (HR [95%CI] = 4.35 [1.60-11.84], p = 0.004). CONCLUSIONS: Severe gastric atrophy and macrocytosis should be noted in the development of metachronous primary GC after ER for esophageal SCC. In particular, macrocytosis at the timing of ER was considered an important predictor. CLINICAL TRIALS REGISTRY NUMBER: UMIN000001676.

A follow-up questionnaire survey 2022 on radiation protection among 464 medical staff from 34 endoscopy-fluoroscopy departments in Japan.

Objectives: We surveyed and reported low protective equipment usage and insufficient knowledge among endoscopy-fluoroscopy departments in Japan in 2020. Two years later, we conducted a follow-up survey of doctors, nurses, and technologists in Japan. Methods: We conducted a questionnaire survey on radiation protection from May to June 2022. The participants were medical staff, including doctors, nurses, and radiological and endoscopy technicians in endoscopy-fluoroscopy departments. The questionnaire included 17 multiple-choice questions divided into three parts: background, equipment, and knowledge. Results: We surveyed 464 subjects from 34 institutions. There were 267 doctors (58%), 153 nurses (33%), and 44 technologists (9%). The rate of wearing a lead apron was 98% in this study. The rates of wearing a thyroid collar, lead glasses, and radiation dosimeter were 27%, 35%, and 74%, respectively. The trend of the protective equipment rate was similar to that of our previous study; however, radiation dosimetry among doctors was still low at 58%. The percentage of subjects who knew the radiation exposure (REX) dose of each procedure was low at 18%. Seventy-six percent of the subjects attended lectures on radiation protection, and 73% knew about the three principles of radiation protection; however, the concept of diagnostic reference levels was not well known (18%). Approximately 60% of the subjects knew about the exposure dose increasing cancer mortality (63%) and the 5-year lens REX limit (56%). Conclusions: There was some improvement in radiation protection equipment or education, but relatively little compared to the 2020 survey of endoscopy departments.

Radiation dose and factors related to exceeding the diagnostic reference level in 496 transnasal ileus tube placement procedures from the REX-GI study.

OBJECTIVE: We aimed to examine the factors contributing to radiation exposure exceeding the DRL of the transnasal ileus tube placement in this post hoc analysis from the cohort of the REX-GI study. METHODS: Patients with transnasal ileus tubes were enrolled in the rex-gi study from may 2019 to december 2020. We investigated the endoscope insertion time (min), procedure time (min), tube insertion length (cm), fluoroscopy time (FT: min), air kerma at the patient entrance reference point (Ka.r: mGy), and air kerma-area product (PKA: Gycm2). The third quartile value of the PKA value was calculated as the diagnostic reference level (DRL) value. We explored the factors associated with radiation exposure exceeding the DRL. RESULTS: In the REX-GI study, 496 patients who underwent transnasal ileus tube placement were enrolled. The median age of the patients was 71 years. The median endoscopy insertion time, procedure time, and tube insertion length were 6 min, 20 min, and 170 cm, respectively. The third quartile/median FT, Ka.r, and PKA were 18/11.9 min, 99.2/54.4 mGy, and 46.9/28 Gycm2, respectively. The third quartile value of PKA (47 Gycm2) was set as the DRL value. There were differences in distribution by the hospital. Compared with procedures under the DRL, the FT (19 vs 10 min), procedure time (25 vs 18 min), and tube insertion length (185 vs 165 cm) were significantly longer for procedures above the DRL. CONCLUSION: We report the DRL for transnasal ileus tube placement in Japan. A longer procedure time and tube insertion length may be associated with DRL exceedance. ADVANCES IN KNOWLEDGE: Transnasal ileus tube placement under fluoroscopy guidance is a standard clinical procedure for bowel obstruction. However, the appropriate radiation dose level has not yet been established.We report the (DRL) for transnasal ileus tube placement in Japan. A longer procedure time and tube insertion length may be associated with DRL exceedance.

Non-atrophic gastric mucosa is an independently associated factor for superficial non-ampullary duodenal epithelial tumors: a multicenter, matched, case-control study.

BACKGROUND/AIMS: The etiology of superficial non-ampullary duodenal epithelial tumors (SNADETs) remains unclear. Recent studies have reported conflicting associations between duodenal tumor development and Helicobacter pylori infection or endoscopic gastric mucosal atrophy. As such, the present study aimed to clarify the relationship between SNADETs and H. pylori infection and/or endoscopic gastric mucosal atrophy. METHODS: This retrospective case-control study reviewed data from 177 consecutive patients with SNADETs who underwent endoscopic or surgical resection at seven institutions in Japan over a three-year period. The prevalence of endoscopic gastric mucosal atrophy and the status of H. pylori infection were compared in 531 sex- and age-matched controls selected from screening endoscopies at two of the seven participating institutions. RESULTS: For H. pylori infection, 85 of 177 (48.0%) patients exhibited SNADETs and 112 of 531 (21.1%) control patients were non-infected (p<0.001). Non-atrophic mucosa (C0 to C1) was observed in 96 of 177 (54.2%) patients with SNADETs and 112 of 531 (21.1%) control patients (p<0.001). Conditional logistic regression analysis revealed that non-atrophic gastric mucosa was an independent risk factor for SNADETs (odds ratio, 5.10; 95% confidence interval, 2.44-8.40; p<0.001). CONCLUSION: Non-atrophic gastric mucosa, regardless of H. pylori infection status, was a factor independently associated with SNADETs.

Usefulness of third-generation narrow band imaging and texture and color enhancement imaging in improving visibility of superficial early gastric cancer: A study using color difference.

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.

Intensive endoscopic resection for downstaging of polyp burden in patients with familial adenomatous polyposis (J-FAPP Study III): a multicenter prospective interventional study.

BACKGROUND: Total colectomy is the standard treatment for familial adenomatous polyposis (FAP). Recently, an increasing number of young patients with FAP have requested the postponement of surgery or have refused to undergo surgery. We aimed to evaluate the effectiveness of intensive endoscopic removal for downstaging of polyp burden (IDP) in FAP. METHOD: A single-arm intervention study was conducted at 22 facilities. Participants were patients with FAP, aged ≥ 16 years, who had not undergone colectomy or who had undergone colectomy but had ≥ 10 cm of large intestine remaining. For IDP, colorectal polyps of ≥ 10 mm were removed, followed by polyps of ≥ 5 mm. The primary end point was the presence/absence of colectomy during a 5-year intervention period. RESULTS: 222 patients were eligible, of whom 166 had not undergone colectomy, 46 had undergone subtotal colectomy with ileorectal anastomosis, and 10 had undergone partial resection of the large intestine. During the intervention period, five patients (2.3 %, 95 % confidence interval [CI] 0.74 %-5.18 %) underwent colectomy, and three patients died. Completion of the 5-year intervention period without colectomy was confirmed in 150 /166 patients who had not undergone colectomy (90.4 %, 95 %CI 84.8 %-94.4 %) and in 47 /56 patients who had previously undergone colectomy (83.9 %, 95 %CI 71.7 %-92.4 %). CONCLUSION: IDP in patients with mild-to-moderate FAP could have the potential to be a useful means of preventing colorectal cancer without implementing colectomy. However, if the IDP protocol was proposed during a much longer term, it may not preclude the possibility that a large proportion of colectomies may still need to be performed.

Resection depth and layer of underwater versus conventional endoscopic mucosal resection of intermediate-sized colorectal polyps: A pilot study.

Background and study aims Curability of colorectal tumors is associated with resection depth and layer in endoscopic resection. Underwater endoscopic mucosal resection (UEMR) has not undergone sufficient histopathological evaluation. We conducted a pilot study to compare the effectiveness, including resection depth and layer, of UEMR and conventional endoscopic mucosal resection (CEMR). Patients and methods This study was a single-center, retrospective study. Patients with colorectal lesions were treated by UEMR or CEMR between January 2018 and March 2020. Eligible patients were selected from included patients in a 1:1 ratio using propensity score matching. We compared the resection depth and layer and treatment results between the UEMR and CEMR groups. Results We evaluated 55 patients undergoing UEMR and 291 patients undergoing CEMR. Using propensity score matching, we analyzed 54 lesions in each group. The proportion of specimens containing submucosal tissue was 100 % in both groups. The median thickness of the submucosal tissue was significantly greater in the CEMR group than in the UEMR group [1235 µm (95 % confidence interval [CI], 1020-1530 µm) vs. 950 µm (95 % CI, 830-1090 µm), respectively]. However, vertical margins were negative in all lesions in both groups. Conclusions Our findings suggest that the median thickness of submucosal tissue in the UEMR group was about 1,000 µm. Even though the resection depth achieved with UEMR was more superficial than that achieved with CEMR, UEMR may be a treatment option, especially for colorectal lesions ≤ 20 mm in diameter without suspicious findings of submucosal deeply invasive cancer.

Assessment of Outcomes From 1-Year Surveillance After Detection of Early Gastric Cancer Among Patients at High Risk in Japan.

Importance: Single endoscopic examination often misses early gastric cancer (GC), even when both high-definition white light imaging and narrow-band imaging are used. It is unknown whether new GC can be detected approximately 1 year after intensive index endoscopic examination. Objective: To examine whether new GC can be detected approximately 1 year after intensive index endoscopic examination using both white light and narrow-band imaging. Design, Setting, and Participants: This case-control study was a preplanned secondary analysis of a randomized clinical trial involving 4523 patients with a high risk of GC who were enrolled between October 1, 2014, and September 22, 2017. Data were analyzed from December 26, 2019, to April 21, 2021. Participants in the clinical trial received index endoscopy to detect early GC via 2 examinations of the entire stomach using white light and narrow-band imaging. The duration of follow-up was 15 months. The secondary analysis included 107 patients with newly detected GC (case group) and 107 matched patients without newly detected GC (control group) within 15 months after index endoscopy. Interventions: Surveillance endoscopy was scheduled between 9 and 15 months after index endoscopy. If new lesions suspected of being early GC were detected during surveillance endoscopy, biopsies were obtained to confirm the presence of cancer. Main Outcomes and Measures: The primary end point was the rate of new GC detected within 15 months after index endoscopy. The main secondary end point was identification of risk factors associated with new GC detected within 15 months after index endoscopy. Results: Among 4523 patients (mean [SD] age, 70.6 [7.5] years; 3527 men [78.0%]; all of Japanese ethnicity) enrolled in the clinical trial, 4472 received index endoscopy; the rate of early GC detected on index endoscopy was 3.0% (133 patients). Surveillance endoscopy was performed in 4146 of 4472 patients (92.7%) who received an index endoscopy; the rate of new GC detected within 15 months after index endoscopy was 2.6% (107 patients). Among 133 patients for whom early GC was detected during index endoscopy, 110 patients (82.7%) received surveillance endoscopy within 15 months after index endoscopy; the rate of newly detected GC was 10.9% (12 patients). For the secondary analysis of risk factors associated with newly detected GC, characteristics were well balanced between the 107 patients included in the case group vs the 107 patients included in the matched control group (mean [SD] age, 71.7 [7.2] years vs 71.8 [7.0] years; 94 men [87.9%] in each group; 82 patients [76.6%] vs 87 patients [81.3%] with a history of gastric neoplasm). Multivariate analysis revealed that the presence of open-type atrophic gastritis (odds ratio, 6.00; 95% CI, 2.25-16.01; P < .001) and early GC detection by index endoscopy (odds ratio, 4.67; 95% CI, 1.08-20.21; P = .04) were independent risk factors associated with new GC detection. Conclusions and Relevance: In this study, the rate of new GC detected by surveillance endoscopy approximately 1 year after index endoscopy was similar to that of early GC detected by index endoscopy. These findings suggest that 1-year surveillance is warranted for patients at high risk of GC.

Diagnosis of histological type of early gastric cancer by magnifying narrow-band imaging: A multicenter prospective study.

Objectives: Distinguishing undifferentiated-type from differentiated-type early gastric cancers (EGC) is crucial for determining the indication of endoscopic resection. We aimed to investigate the diagnostic performance of white-light endoscopy (WLE) and magnifying narrow-band imaging (M-NBI) for the histological type of EGC. Methods: In this multicenter prospective study, patients with histologically proven cT1 EGC, macroscopically depressed or flat type, size ≥5 mm, and without erosion/ulcer, were recruited. The diagnostic criterion of WLE for undifferentiated-type EGC was pale color. The M-NBI algorithm was created based on microsurface and microvascular patterns, and lesions with absent microsurface pattern and opened-loop microvascular patterns were diagnosed as undifferentiated-type. The center of the lesion was defined as the evaluation point and was initially evaluated by WLE, then by M-NBI, and a biopsy specimen was taken as a reference standard. The primary and key secondary endpoints were overall diagnostic accuracy and specificity, respectively. Results: In total, 167 lesions (122 differentiated-type and 45 undifferentiated-type EGCs) in 167 patients were analyzed. The overall accuracy, sensitivity, specificity, and positive likelihood ratio of WLE for undifferentiated-type cancer were 80%, 69%, 84%, and 4.4, respectively, and those of M-NBI were 82%, 53%, 93%, and 7.2, respectively. There was no significant difference in overall accuracy (p = 0.755), but specificity was significantly higher in M-NBI (p = 0.041). Conclusions: The use of M-NBI did not improve the accuracy of WLE for the diagnosis of depressed/flat undifferentiated-type EGCs but improved the specificity. It may reduce surgical overtreatment by preventing misdiagnosis of differentiated-type EGC as undifferentiated-type.

Usefulness of the clip-and-snare method using the pre-looping technique for endoscopic submucosal dissection of gastric neoplasia: a randomized controlled trial.

BACKGROUND: The clip-and-snare method using the pre-looping technique (CSM-PLT) was developed as a traction method for endoscopic submucosal dissection (ESD) of gastric neoplasia. However, its usefulness has not been clearly established; thus, we aimed to assess the efficacy of CSM-PLT in gastric ESD. METHODS: In this multicenter, randomized controlled trial, patients with gastric adenoma or carcinoma with absolute or expanded indications for ESD were randomized into conventional ESD and CSM-PLT groups, using the minimization method based on operator experience, tumor location, tumor size, and excision device. The primary endpoint was ESD procedure time. Secondary endpoints were en bloc and R0 resection rates, and complications. RESULTS: We enrolled 402 patients between July 2017 and February 2020. After excluding patients with deviations from the protocol, we finally analyzed the data of 192 and 186 patients in the conventional and CSM-PLT groups, respectively. The procedure time was significantly shorter in the CSM-PLT group than in the conventional group (58.0 vs. 69.7 min; P=0.009). All lesions were resected en bloc. The R0 resection rate tended to be higher in the CSM-PLT group (P=0.09). No significant differences in complications were observed between the 2 groups. CONCLUSIONS: CSM-PLT is beneficial for gastric ESD when compared with the conventional technique. CSM-PLT significantly reduced procedure times and improved R0 resection rates.

Outcomes of endoscopic submucosal dissection for colorectal neoplasms: Prospective, multicenter, cohort trial.

OBJECTIVES: Endoscopic mucosal resection (EMR) is the gold standard for the treatment of noninvasive large colorectal lesions, despite challenges associated with nonlifting lesions and a high rate of local recurrence. Endoscopic submucosal dissection (ESD) offers the possibility of overcoming these EMR limitations. However, a higher risk of complications and longer procedure time prevented its dissemination. As ESD now provides more stable results because of standardized techniques compared with those used earlier, this study aimed to quantify the rates of en bloc and curative resections, as well as ESD complications, in the present situation. METHODS: A multicenter, large-scale, prospective cohort trial of ESD was conducted at 20 institutions in Japan. Consecutive patients scheduled for ESD were enrolled from February 2013 to January 2015. RESULTS: ESD was performed for 1883 patients (1965 lesions). The mean procedure time was 80.6 min; en bloc and curative resections were achieved in 1759 (97.0%) and 1640 (90.4%) lesions, respectively, in epithelial lesions ≥20 mm. Intra- and postprocedural perforations occurred in 51 (2.6%) and 12 (0.6%) lesions, respectively, and emergency surgery for adverse events was performed in nine patients (0.5%). CONCLUSIONS: This trial conducted after the standardization of the ESD technique throughout Japan revealed a higher curability, shorter procedure time, and lower risk of complications than those reported previously. Considering that the target lesions of ESD are more advanced than those of EMR, ESD can be a first-line treatment for large colorectal lesions with acceptable risk and procedure time. (Clinical Trial Registration: UMIN000010136).