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.

Effectiveness of Strategy-Focused Training in Colorectal Endoscopic Submucosal Dissection: A Retrospective Observational Study.

BACKGROUND: Colorectal ESD, an advanced minimally invasive treatment, presents technical challenges, with globally varying training methods. We analyzed the learning curve of ESD training, emphasizing preoperative strategies, notably gravity traction, to guide ESD instructors and trainee programs. METHOD: This retrospective study included 881 cases guided by an experienced supervisor. Six trainees received "strategy-focused" instruction. To evaluate the number of ESD experiences in steps, the following phases were classified based on ESD experiences of each trainees: Phase 0 (0-50 ESD), Phase 1 (51-100 ESD), Phase 2 (101-150 ESD), and Phase 3 (151-200 ESD). Lesion background, outcomes, and safety were compared across phases. Factors contributing to technical difficulty in early (Phase 0 and 1) and late phases (Phase 2 and 3) were identified, along with the utility of traction ESD with device assistance. RESULT: Treatment outcomes were favorable, with 99.8% and 94.7% en bloc resection and curative resection rates, respectively. Approximately 90% self-completion rate could be achieved after experiencing about 50 cases (92.7% in Phase 1), signifying proficiency growth despite increased case difficulty. In early phases, factors such as left-sided colon, LST-NG morphology, and severe fibrosis pose challenges. In late phases, LST-NG morphology, mild and severe fibrosis remained significant. Traction-assisted ESD, utilized in 3% of cases, comprised planned (1.1%) and rescue (1.9%) methods. Planned traction aided specific lesions, while rescue traction was common in the right colon. CONCLUSION: "Strategy-focused" ESD training consistently yields successful outcomes, effectively adapting to varying difficulty factors in different proficient stages.

The Management of Direct Oral Anticoagulants for Colorectal Endoscopic Submucosal Dissection: A Multicenter Observational Study.

BACKGROUND: There is a lack of reports on the use of direct oral anticoagulants (DOACs) during colorectal endoscopic submucosal dissection (ESD). AIMS: We aimed to assess whether the use of DOACs is associated with a higher incidence of delayed bleeding (DB) after ESD. METHODS: A total of 4175 colorectal neoplasms in 3515 patients were dissected at our hospitals during study period. We included 3909 lesions in the final analysis. The lesions were divided into two groups: the no-AT group (3668 neoplasms) and the DOAC group (241 neoplasms). We also compared the DOAC withdrawal group (154 neoplasms) and the DOAC continuation group (87 neoplasms). RESULTS: Among the 3909 lesions, DB occurred in a total of 90 cases (2.3%). The rate of DB was 2.2% (82/3668), and 3.3% (8/241), respectively. There were no significant differences in the rate of DB between the no-AT group and the DOAC group. In the DOAC group, there were no significant differences in the rate of DB between the withdrawal group (5.2%, 8/154) and the continuation group (0%, 0/87). The multivariable analysis identified the location of the lesion in the rectum (odds ratio [OR], 4.04; 95% confidence interval [CI], 2.614-6.242; p < 0.001) and lesions ≥ 30 mm in diameter (OR, 4.14; 95% CI, 2.349-7.34; p < 0.001) as independent risk factors for DB. CONCLUSIONS: Our findings suggest that DOAC use has no significant important on the rate of DB. Prospective studies are warranted to determine whether treatment with DOACs should be interrupted prior to colorectal ESD.

Long-term Outcomes After Endoscopic Submucosal Dissection for Large Colorectal Epithelial Neoplasms: A Prospective, Multicenter, Cohort Trial From Japan.

BACKGROUND & AIMS: To determine the long-term outcomes after colorectal endoscopic submucosal dissection (ESD), we conducted a large, multicenter, prospective cohort trial with a 5-year observation period. METHODS: Between February 2013 and January 2015, we consecutively enrolled 1740 patients with 1814 colorectal epithelial neoplasms ≥20 mm who underwent ESD. Patients with noncurative resection (non-CR) lesions underwent additional radical surgery, as needed. After the initial treatment, intensive 5-year follow-up with planned multiple colonoscopies was conducted to identify metastatic and/or local recurrences. Primary outcomes were overall survival, disease-specific survival, and intestinal preservation rates. The rates of local recurrence and metachronous invasive cancer were evaluated as the secondary outcomes. RESULTS: The 5-year overall survival, disease-specific survival, and intestinal preservation rates were 93.6%, 99.6%, and 88.6%, respectively. Patients with CR lesions had no metastatic occurrence, and patients with non-CR lesions had 4 metastatic occurrences. Kaplan-Meier curves revealed that overall survival and disease-specific survival rates were significantly higher in patients with CR lesions than in those with non-CR lesions (P > .001 and P = .009, respectively). Local recurrence occurred in only 8 lesions (0.5%), which were successfully resected by subsequent endoscopic treatment. Multiple logistic regression analyses revealed that piecemeal resection (hazard ratio, 8.19; 95% CI, 1.47-45.7; P = .02) and margin-positive resection (hazard ratio, 8.06; 95% CI, 1.76-37.0; P = .007) were significant independent predictors of local recurrence after colorectal ESD. Fifteen metachronous invasive cancers (1.0%) were identified during surveillance colonoscopy, most of which required surgical resection. CONCLUSIONS: A favorable long-term prognosis indicates that ESD can be the standard treatment for large colorectal epithelial neoplasms. CLINICAL TRIAL REGISTRATION NUMBER: UMIN000010136.

Endoscopic resection for gastric submucosal tumors: Japanese multicenter retrospective study.

OBJECTIVES: Limited information is available on the efficacy and safety of endoscopic resection (ER) of gastric submucosal tumors (SMTs) in Japanese endoscopic practice where ER for gastric tumors is extremely popular. METHODS: We conducted this study to elucidate the current scenario of ER for gastric SMTs in Japanese endoscopic practice. Patients (from 12 institutions) with gastric SMTs who underwent ER were enrolled from the first case until August 2020. RESULTS: We enrolled 117 patients with 118 lesions. The number of patients who underwent ER increased over the years. The mean endoscopic tumor size was 20 ± 7.2 (8-40) mm. The growth type was primarily intraluminal (90%). The mean resection and wound closure times were 58 ± 38 (range, 12-254) min and 31 ± 41 (range, 3-330) min, respectively. Complete ER was achieved for 117 (99%) lesions. Full-thickness resection rate was 44%; however, only 12 (10%) patients required abdominal paracentesis for decompression. Endoscopic treatments were completed in 115 (97%) lesions, while three lesions required conversions to laparoscopic surgery due to luminal collapse, uncontrolled bleeding, and difficulty in defect closure. Gastrointestinal stromal tumors were the most common pathology (74%). No recurrence was observed during the mean follow-up period of 4.3 ± 2.9 years. The 5-year overall survival rate was 98.9% (95% confidence interval 97.8-100%). CONCLUSION: Performance of ER for gastric SMTs is increasing in Japan. The technique seems feasible in Japanese endoscopic practice, warranting further validation in a prospective study.

Clinical course and management of adverse events after endoscopic resection of superficial duodenal epithelial tumors: Multicenter retrospective study.

OBJECTIVES: This study aimed to elucidate the clinical course and management of adverse events (AEs) after endoscopic resection (ER) for superficial duodenal epithelial tumors (SDETs). METHODS: Consecutive patients who underwent ER of SDETs between January 2008 and July 2018 at 18 Japanese institutions were retrospectively enrolled. The study outcomes included the clinical course, management, and risk of surgical conversion with perioperative AEs after ER for SDETs. RESULTS: Of the 226 patients with AEs, the surgical conversion rate was 8.0% (18/226), including 3.7% (4/108), 1.0% (1/99), and 50.0% (12/24) of patients with intraoperative perforation, delayed bleeding, or delayed perforation, respectively. In the multivariate logistic analysis, involvement of the major papilla (odds ratio [OR] 12.788; 95% confidence interval [CI] 2.098-77.961, P = 0.006) and delayed perforation (OR 37.054; 95% CI 10.219-134.366, P < 0.001) were significant risk factors for surgical conversion after AEs. Delayed bleeding occurred from postoperative days 1-14 or more, whereas delayed perforation occurred within 3 days in all cases. CONCLUSIONS: The surgical conversion rate was higher for delayed perforation than those for other AEs after ER of SDETs. Involvement of the major papilla and delayed perforation were significant risk factors for surgical conversion following AEs. In addition, reliable prevention of delayed perforation is required for 3 days after duodenal ER to prevent the need for surgical interventions.

Short-term and long-term outcomes of submucosal dissection for residual or recurrent colorectal tumors after endoscopic resection: Analysis of a multicenter prospective study.

OBJECTIVES: We previously demonstrated that a favorable long-term prognosis indicated that endoscopic submucosal dissection (ESD) could be the standard treatment for large colorectal epithelial neoplasms, but the usefulness of ESD for local residual or recurrent tumors with submucosal fibrosis has not been fully demonstrated. The aim of the present study was to assess the usefulness of ESD for local residual or recurrent colorectal tumors. METHODS: We conducted a nationwide multicenter prospective study to evaluate the outcomes of ESD for colorectal tumors. In this post hoc analysis, a total of 54 local residual or recurrent colorectal tumors in 54 patients were included, and we analyzed the short-term and long-term outcomes of ESD for these lesions. RESULTS: The median size of the lesions was 16.0 (interquartile range [IQR] 11-25) mm. ESD was completed in 53 cases (98.1%) with a median procedure time of 65.0 min, but it was discontinued in one case because of submucosal cancer invasion. En bloc resection was achieved in 52 cases (96.3%), whereas R0 resection was achieved in 45 cases (83.3%). Intraoperative perforation was observed in four cases (7.4%) and delayed perforation in one (1.9%), but all cases could be managed conservatively. Delayed bleeding was not observed. There were no significant differences in short-term outcomes between the rectal and colonic lesions. There was no recurrence of the tumor during the median follow-up period of 60 (IQR 50-64) months. CONCLUSION: An analysis of our multicenter prospective study suggests that ESD is an effective salvage management for local residual or recurrent colorectal lesions.

Safety and Efficacy of Cold Snare Polypectomy Without Submucosal Injection for Large Sessile Serrated Lesions: A Prospective Study.

BACKGROUND & AIMS: Cold snare polypectomy (CSP) has become the standard resection method for small colorectal polyps (<10 mm). Sessile serrated lesions (SSL) have low prevalence of advanced histology irrespective of size, and thus could be amenable to CSP. In this study, we evaluated the safety and efficacy of CSP for SSLs ≥10 mm. METHODS: Between November 2018 and January 2020, we prospectively enrolled 300 consecutive patients who underwent CSP for 474 SSLs ≥10 mm. To delineate SSL borders, indigo carmine chromoendoscopy and/or image-enhanced endoscopy was conducted. Piecemeal CSP (pCSP) was performed in cases where en-bloc resection was difficult. Biopsy specimens were obtained from the margins of the post-polypectomy defect to confirm complete resection. Surveillance colonoscopy was performed to screen for local recurrence. RESULTS: All lesions were successfully resected using CSP without submucosal injection. The median diameter of the resected lesions was 14 mm, and pCSP was used to resect 106 (22%) lesions. Post-polypectomy biopsies revealed residual serrated tissue in only one case (0.2%). Adverse events included immediate bleeding in 8 (3%) patients; no delayed bleeding events occurred, irrespective of the use of antithrombotic drugs. During a 7-month median follow-up period, surveillance colonoscopies were performed for 384 lesions (81%), and no local recurrences were detected. CONCLUSIONS: CSP without submucosal injection is a safe and effective treatment for SSLs ≥10 mm. UMIN Clinical Trials, Number: UMIN000034763.

Outcomes of endoscopic resection for superficial duodenal tumors: 10 years' experience in 18 Japanese high volume centers.

BACKGROUND: Data on endoscopic resection (ER) for superficial duodenal epithelial tumors (SDETs) are insufficient owing to their rarity. There are two main ER techniques for SDETs: endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). In addition, modified EMR techniques, such as underwater EMR (UEMR) and cold polypectomy, are becoming popular. We conducted a large-scale retrospective multicenter study to clarify the detailed outcomes of duodenal ER. METHODS: Patients with SDETs who underwent ER at 18 institutions from January 2008 to December 2018 were included. The rates of en bloc resection and delayed adverse events (AEs; defined as delayed bleeding or perforation) were analyzed. Local recurrence was analyzed using the Kaplan-Meier method. RESULTS: In total, 3107 patients (including 1017 undergoing ESD) were included. En bloc resection rates were 79.1 %, 78.6 %, 86.8 %, and 94.8 %, and delayed AE rates were 0.5 %, 2.2 %, 2.8 %, and 6.8 % for cold polypectomy, UEMR, EMR and ESD, respectively. The delayed AE rate was significantly higher in the ESD group than in non-ESD groups for lesions < 19 mm (7.4 % vs. 1.9 %; P < 0.001), but not for lesions > 20 mm (6.1 % vs. 7.1 %; P = 0.64). The local recurrence rate was significantly lower in the ESD group than in the non-ESD groups (P < 0.001). Furthermore, for lesions > 30 mm, the cumulative local recurrence rate at 2 years was 22.6 % in the non-ESD groups compared with only 1.6 % in the ESD group (P < 0.001). CONCLUSIONS: ER outcomes for SDETs were generally acceptable. ESD by highly experienced endoscopists might be an option for very large SDETs.

The feasibility and safety of endoscopic submucosal dissection of gastric lesions larger than 5 cm.

BACKGROUND: As the indications for endoscopic submucosal dissection (ESD) for early gastric cancer have been revised, diagnostic ESD has increased. However, despite the technical difficulty of ESD for large lesions, the degree to which curative resection can be achieved has not been clarified. This study investigated the feasibility and safety of ESD for gastric lesions larger than 5 cm. METHODS: This retrospective multicenter study included 3474 gastric lesions treated by ESD from April 2012 to December 2021. We compared clinicopathological characteristics and treatment outcomes between lesions ≥ 5 cm and lesions < 5 cm. RESULTS: There were 128 lesions in the ≥ 5 cm group and 3282 lesions in the < 5 cm group. In the ≥ 5 cm group, upper location and fibrosis during ESD were more common, with a lower rate of 0-IIc type. Both en bloc resection rate and R0 resection rate were comparable, but there was a difference in curative resection rate (65.6% in the ≥ 5 cm group and 91.5% in the < 5 cm group). The frequency of adverse events (post-ESD bleeding, perforation, or stenosis) was almost similar, but delayed perforation was significantly more common (1.6% in the ≥ 5 cm group vs. 0.1% in the < 5 cm group). CONCLUSIONS: About two-thirds of curative resections were obtained with ESD for early gastric lesions larger than 5 cm, but delayed complications should be noted (Number: UMIN000047725).

The feasibility of endoscopic submucosal dissection for colorectal lesions larger than 10 cm.

BACKGROUND: Although endoscopic submucosal dissection (ESD) enables en bloc removal of colorectal neoplasms, its effectiveness for larger lesions (≥ 10 cm in diameter) is undetermined. We aimed to investigate the feasibility and safety of ESD for colorectal lesions ≥ 10 cm wide. METHODS: This retrospective study included 3591 consecutive colorectal lesions managed with ESD from June 2012 through December 2020. Clinicopathological characteristics and treatment outcomes were compared between lesions ≥ 10 cm wide and lesions 5-10 cm wide. RESULTS: There were 50 patients in the ≥ 10 cm group and 270 patients in the 5-10 cm group. Among patients in the ≥ 10 cm group, lesions were most often in the rectum (50.0%), and the laterally spreading tumor-granular nodular mixed type (LST-G-M) was most prevalent (41/50, 82%). Although patients in the ≥ 10 cm group a longer mean ESD procedure time (186.0 vs. 94.4 min, p < 0.001), the dissection speed was significantly higher in this group (0.50 vs. 0.41 cm2/min, p = 0.003). The en bloc and curative resection rates were comparable between the ≥ 10 cm and 5-10 cm groups (100% vs. 99.6% and 86.0% vs. 88.5%, respectively). Although the stenosis rate was higher in the ≥ 10 cm group (4% vs. 0%), the delayed bleeding and perforation rates were similar between the two groups. CONCLUSIONS: ESD for colorectal lesions ≥ 10 cm wide is feasible and curative, even though it is associated with higher technical difficulty and longer procedure times compared with ESD for smaller lesions (Number: UMIN 000044313).

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).

Early gastric cancer detection in high-risk patients: a multicentre randomised controlled trial on the effect of second-generation narrow band imaging.

OBJECTIVE: Early detection of gastric cancer has been the topic of major efforts in high prevalence areas. Whether advanced imaging methods, such as second-generation narrow band imaging (2G-NBI) can improve early detection, is unknown. DESIGN: This open-label, randomised, controlled tandem trial was conducted in 13 hospitals. Patients at increased risk for gastric cancer were randomly assigned to primary white light imaging (WLI) followed by secondary 2G-NBI (WLI group: n=2258) and primary 2G-NBI followed by secondary WLI (2G-NBI group: n=2265) performed by the same examiner. Suspected early gastric cancer (EGC) lesions in both groups were biopsied. Primary endpoint was the rate of EGC patients in the primary examination. The main secondary endpoint was the positive predictive value (PPV) for EGC in suspicious lesions detected (primary examination). RESULTS: EGCs were found in 44 (1.9%) and 53 (2.3%; p=0.412) patients in the WLI and 2G-NBI groups, respectively, during primary EGD. In a post hoc analysis, the overall rate of lesions detected at the second examination was 25% (n=36/145), with no significant differences between groups. PPV for EGC in suspicious lesions was 13.5% and 20.9% in the WLI (50/371 target lesions) and 2G-NBI groups (59/282 target lesions), respectively (p=0.015). CONCLUSION: The overall sensitivity of primary endoscopy for the detection of EGC in high-risk patients was only 75% and should be improved. 2G-NBI did not increase EGC detection rate over conventional WLI. The impact of a slightly better PPV of 2G-NBI has to be evaluated further. TRIAL REGISTRATION NUMBER: UMIN000014503.

Evaluation of colorectal endoscopic submucosal dissection using a multifunctional snare: a prospective clinical feasibility study (with videos).

BACKGROUND AND AIMS: The number of colorectal endoscopic submucosal dissections (ESDs) for early colorectal cancer is expected to increase in the future; therefore, cost reduction is a clinically important issue. The SOUTEN snare (Kaneka Medics, Tokyo, Japan) is a novel multifunctional snare developed for hybrid ESD at a low price. If ESD can be performed safely using the SOUTEN snare, the same therapeutic effect can be obtained as with conventional ESD at a lower cost. The aim of this prospective, pilot, clinical feasibility study was to evaluate the safety and efficacy of ESD using the SOUTEN snare (SOUTEN-ESD). METHODS: From October 2018 to January 2019, 119 consecutive patients (121 ESD procedures, 137 colorectal neoplasms) were prospectively enrolled and treated by SOUTEN-ESD at NTT Medical Center Tokyo and Omori Red Cross Hospital. The outcomes of SOUTEN-ESD were evaluated. RESULTS: Among 137 neoplasms, SOUTEN-ESD was completed in all cases. No cases required conversion to hybrid ESD or to a dedicated ESD device. The mean procedure time was 26.1 ± 14.3 minutes. Both the en-bloc resection rate and R0 resection rate were 100%. The rate of perforation was 0%, the rate of delayed bleeding was 2.2%, and the rate of post-ESD coagulation syndrome was 2.9%. CONCLUSIONS: SOUTEN-ESD was safe and had good outcomes. Although further studies are required to examine indications for SOUTEN-ESD and confirm the results of this study, effective ESD with this novel knife is feasible. The SOUTEN snare is a realistic option for colorectal ESD. (Clinical trial registration number: UMIN 000034299.).

Endoscopic submucosal dissection of large pedunculated polyps with wide stalks: a retrospective multicenter study.

BACKGROUND: Endoscopic resection of large pedunculated colorectal polyps is technically difficult, especially when the polyp is large and has such a thick stalk that it is either too difficult or impossible to resect prophylactically by a conventional snare. Here, we evaluated the feasibility of ESD for large pedunculated polyps with wide stalks. METHODS: 29 patients with large pedunculated polyps that were not resectable by polypectomy or endoscopic mucosal resection were enrolled in the study. RESULTS: En bloc resection was achieved in 28/29 polyps. One suspended case was due to severe fibrosis with muscle retraction signs. The mean diameter of the 29 polyp heads was 39.7 (standard deviation 6.9) mm. Submucosal fibrosis was present in 16 polyps (9 mild; 7 severe). The stalks of severely fibrotic polyps were significantly thicker than those of polyps with no or mild fibrosis. The curative resection rate was 85.7 % without severe complications. CONCLUSIONS: ESD is feasible for the removal of large pedunculated polyps with wide stalks when conventional snare resection is difficult or impossible.

Safety and feasibility of laparoscopic and endoscopic cooperative surgery for duodenal neoplasm: a retrospective multicenter study.

BACKGROUND: A delayed perforation can often occur after endoscopic treatment for duodenal neoplasms and may be fatal due to leakage of pancreatic and bile juices. We aimed to evaluate the feasibility and safety of laparoscopic and endoscopic cooperative surgery for duodenal neoplasms (D-LECS) in a multicenter, retrospective study. METHODS: The clinical characteristics and surgical outcomes of 206 patients with duodenal neoplasms in whom D-LECS had initially been attempted at one of 14 institutions were reviewed retrospectively. RESULTS: Of the 206 patients, 63 (30.6 %), 128 (62.1 %), and 15 patients (7.3 %) had lesions at the bulb, second portion, and third portion of the duodenum, respectively. The rates of en bloc and R0 resections during D-LECS were 96.1 % and 95.1 %, respectively. Intraoperative and delayed perforations occurred in 10 (4.9 %) and 5 patients (2.4 %), respectively. No cases of recurrence were observed. Surgical duration of ≥ 180 minutes was an independent risk factor for postoperative complications. CONCLUSIONS: The results revealed that D-LECS was performed with oncological safety and technical feasibility.

A new classification for the diagnosis of superficial non-ampullary duodenal epithelial tumors using endocytoscopy: A prospective study.

BACKGROUND AND AIM: Although the frequency of endoscopic diagnosis of superficial non-ampullary duodenal epithelial tumors (SNADETs) has been increasing in recent years, no criteria for the endoscopic diagnosis of these tumors have been established yet. The aim of this study was to assess the usefulness of endocytoscopy for diagnosis SNADETs and to establish new criteria. METHODS: This prospective study was conducted at the NTT Medical Center Tokyo from May 2019 to July 2020, and a total of 100 consecutive SNADETs were enrolled. All the endocytoscopic images of the lesions and surrounding normal mucosa were classified into three groups according to the degree of structural atypia and the nuclear morphology and size. The endocytoscopic diagnoses using endocytoscopic classification was compared with the final histopathological diagnoses. RESULTS: Data of 93 patients with 98 lesions were included in the analysis. The preoperative diagnosis by endocytoscopy coincided with the final histopathological diagnosis in 85 (86.7%) of 98 SNADETs. In addition, the sensitivity and specificity for VCL 4/5 were 87.7% and 85.4%, respectively. In contrast, the accuracy, sensitivity, and specificity of preoperative diagnosis by biopsy were 64.3%, 50.9%, and 82.9%, respectively. Preoperative diagnosis by endocytoscopy showed significantly superior accuracy and sensitivity as compared with preoperative biopsy diagnosis (P < 0.001, respectively). CONCLUSIONS: This new classification (endocytoscopic classification) allows prediction of the tumor histopathology in real time, during endocytoscopy without biopsy, and is expected to be of help in determining the appropriate therapeutic strategies for individual cases of SNADETs. (Clinical trial registration number: UMIN000038643.).

Endoscopic submucosal dissection for colorectal neoplasms in proximity or extending to a diverticulum.

BACKGROUND AND AIMS: At specialized facilities, endoscopic submucosal dissection (ESD) has currently been performed even for difficult cases such as tumors extending to a diverticulum that previously required surgery. This study aims to classify the type of lesion according to the degree of infiltration to a diverticulum and assessed the safety and efficacy of ESD for each type of lesion. METHODS: We retrospectively reviewed ESD for lesions at NTT Medical Center Tokyo between January 2014 and April 2019. Lesions were classified as follows: Type 1: lesions in contact with or within 3 mm of the edge of a diverticulum; Type 2: lesions that partially infiltrated into a diverticulum; and Type 3: lesions that infiltrated into and completely covered the diverticulum. Furthermore, ESD strategies were divided into A and B, which indicates that a lesion was resected separately from the diverticulum and along the entire diverticulum, respectively. The clinicopathological characteristics and clinical outcomes were analyzed according to the strategy. RESULTS: A total of 47 lesions satisfied inclusion criteria (19 Type 1, 12 Type 2, and 16 Type 3 lesions). 19 Type 1 and 8 Type 2 lesions were resected using Strategy A, while 4 Type 2 and 16 Type 3 lesions were resected using Strategy B. En bloc resection was achieved in all cases. In Strategy A, the R0 resection rate was 96.3% and the curative resection rate was 88.9%. On the contrary, in Strategy B, the R0 resection rate was 95.0% and the curative resection rate was 90.0%. In Strategy B, one of the patients developed post-operative bleeding that required endoscopic hemostasis; another patient developed delayed perforation that required emergency surgery. CONCLUSIONS: ESD for colorectal neoplasms in proximity or extending to a diverticulum is challenging, but this procedure can be a safe and effective therapeutic option.

Simple scoring system for the diagnosis of superficial non-ampullary duodenal epithelial tumors.

BACKGROUND AND AIMS: Differentiating superficial non-ampullary duodenal epithelial tumors (SNADETs) that harbor malignant potential is important. We developed a simple scoring system and investigated whether it enables the differentiation of low-grade adenoma and high-grade adenoma/adenocarcinoma. PATIENTS AND METHODS: We retrospectively enrolled 197 consecutive patients with 207 SNADETs who underwent endoscopic resection at NTT Medical Center Tokyo between March 2016 and May 2019. Endoscopic findings were compared between Vienna Classification (VCL) C3 and C4/5 lesions. A multivariate logistic regression analysis was performed to develop a scoring system to identify VCL C4/5 lesions. The efficacy of our scoring system was elucidated among five novice and five expert endoscopists. RESULTS: Of 207 SNADETs, 66 and 141 lesions were pathologically diagnosed as VCL C3 and C4/5. A multivariate logistic regression analysis identified a tumor diameter of 10-19 mm (OR, 3.81; 95% CI, 1.02-14.2; P = 0.04), a tumor diameter ≥20 mm (OR, 95.2; 95% CI, 10.4-871.0; P < 0.001), a red color (OR, 14.5; 95% CI, 3.55-59.6; P < 0.001), the presence of irregular surface pattern (OR, 12.4; 95% CI, 3.00-51.4; P < 0.001), and the presence of irregular vessel pattern (OR, 13.7; 95% CI, 4.03-46.6; P < 0.001) as independent significant predictors of VCL C4/5. Considering these results, we developed a scoring system. Using an appropriate cutoff value, the diagnostic accuracy, sensitivity and specificity were calculated as 92%, 95% and 93%. The average diagnostic accuracy did not differ between novice and expert endoscopists (86% vs 87%, P = 0.76). CONCLUSIONS: Our scoring system was useful for differentiating VCL C3 and C4/5 lesions. UMIN Clinical Trials (No. 000039063).

Risk factors of delayed bleeding after endoscopic resection of superficial non-ampullary duodenal epithelial tumors and prevention by over-the-scope and conventional clipping.

OBJECTIVES: This study was aimed to reveal risk factors for delayed bleeding after endoscopic resection (ER) of superficial non-ampullary duodenal epithelial tumors (SNADETs) and at exploring measures to prevent this complication. METHODS: A total of 235 consecutive patients with 249 SNADETs who had undergone ER were enrolled in this study. They were divided into two groups: OTSC group, consisting of the initial 114 cases in which the defects were closed only using OTSCs; and OTSC-c group, consisting of the later 135 cases in which conventional clips were additionally used to cover the inverted submucosa after post-procedure defect closure using OTSCs. The therapeutic outcomes were then compared between the OTSC and OTSC-c groups. RESULTS: All lesions were successfully resected en-bloc, and the R0 resection rate was 92.4%. The complete defect closure rate was 90.0% and no delayed perforation occurred when successful defect closure was achieved. The rate of delayed bleeding was significantly higher in the OTSC group than in OTSC-c group (11.4% vs. 1.5%, P = 0.001). Multivariate logistic regression analyses revealed that tumor location distal to the ampulla (OR 10.0; 95% CI 1.24-81.0, P = 0.03) and use of a DOAC (OR 8.83; 95% CI 1.13-68.7, P = 0.04) were significant independent predictors of delayed bleeding. Propensity score-matching analysis revealed that additional use of conventional clips was associated with a significantly reduced risk of delayed bleeding (P = 0.003). CONCLUSIONS: Additional use of conventional clips after prophylactic defect closure using OTSCs appears to be useful to reduce the risk of delayed bleeding after ER of SNADETs. UMIN Clinical Trials (No. 000035478).