Outcomes of endoscopic submucosal dissection for esophageal cancer with segmental absence of intestinal musculature.

BACKGROUND AND AIMS: Perforation during esophageal endoscopic submucosal dissection (ESD) typically results from electrical damage. However, there are cases in which perforation occurs because of segmental absence of intestinal musculature (SAIM) without iatrogenic muscular injury. We investigated the occurrence rate and clinical course of SAIM during esophageal ESD. METHODS: We conducted a retrospective review of esophageal ESDs performed between 2013 and 2019 at 10 centers in Japan. RESULTS: Five of 1708 (0.29%) patients received ESD for esophageal cancer and had SAIM. The median muscular defect size was 20 mm. All lesions were resected without discontinuation. After resection, 3 patients were closed with Endoloop. Four patients had mediastinal emphysema. All patients were managed conservatively. CONCLUSIONS: SAIM is a very rare condition that is usually only diagnosed during ESD. Physicians performing esophageal ESD should be aware of SAIM. When SAIM is detected, the ESD technique should be modified to prevent full-thickness perforation.

Potential for expanding indications and curability criteria of endoscopic resection for early gastric cancer in elderly patients: results from a Japanese multicenter prospective cohort study.

BACKGROUND AND AIMS: Evidence for endoscopic resection (ER) in elderly patients with early gastric cancer (EGC) is limited. We assessed its clinical outcomes, and explored new indications and curability criteria. METHODS: We analyzed data from a Japanese multicenter prospective cohort study. Patients aged ≥75 years with EGC treated with ER were included. We classified "eCuraC-2 (corresponding to noncurative ER, defined in the Japanese gastric cancer treatment guidelines)" into "elderly-high (EL-H)" (>10% estimated metastatic risk) and "elderly-low (EL-L)" (≤10%). RESULTS: In total, 3,371 patients with 3,821 EGCs were included; endoscopic submucosal dissection (ESD) was the prominent treatment choice. Among them, 3,586 lesions met the guidelines' ER indications and 235 did not. The proportions of en bloc and R0 resections and perforations were 98.9%, 94.4%, and 0.8%, respectively, in EGCs within the indications. In EGCs beyond the indications, they were 99.5%, 85.4%, and 5.9%, respectively, for lesions diagnosed as ≤3 cm, and 96.0%, 64.0%, and 18.0% for those >3 cm. Curative ER ("eCuraA/B") and EL-L were observed in 83.6% and 6.2% of lesions within the indications, respectively, and in 44.2% and 16.8% of lesions <3 cm beyond the indications, respectively. The 5-year cumulative gastric cancer death rates following eCuraA/B and EL-H were 0.3% (95% CI, 0.2-0.6) and 3.5% (2.0-5.7), respectively. Following EL-L, the rate was 0.9% (0.2-3.5) even without subsequent treatment. CONCLUSIONS: Usefulness of ESD for elderly EGC patients was confirmed by their clinical outcomes. Lesions ≤3 cm and EL-L emerged as new ER indication and curability criterion, respectively.

Efficacy and safety of same-day preparation with sodium picosulfate plus magnesium citrate on the day of colonoscopy for bowel preparation: Multicenter, single-arm, open-label study.

BACKGROUND AND AIM: Sodium picosulfate plus magnesium citrate (SP + MC) is a well-tolerated bowel preparation agent. However, Japan currently approves only two methods of taking SP + MC: the day-before and split-dose preparation, without approval of same-day preparations. This study aimed to evaluate the efficacy and safety of same-day SP + MC preparations. METHODS: This was a multicenter, single-arm, nonrandomized, open-label study. We enrolled 145 Japanese patients between June and December 2023. The patients received two sachets of SP + MC dissolved in 300 ml of water and 1200 mL or more of clear liquid on the day of colonoscopy. Bowel cleansing efficacy, adverse events (AEs), and patient satisfaction were evaluated. RESULTS: Of the enrolled patients, 137 underwent colonoscopy according to our protocol. Bowel preparation was adequate in 133 patients (97.1%). The mean total Boston Bowel Preparation Score was 8.3 ± 1.2. Five patients experienced AEs (3.6%): two (1.5%), abdominal pain; one (0.73%), ischemic enteritis; one (0.73%), vomiting or nausea; and one (0.73%), headache. All AEs were treated conservatively. None of the patients exhibited abnormal blood test results or clinical symptoms after receiving SP + MC. Regarding patient satisfaction, all patients were able to take SP + MC as directed; 136 (99.2%) expressed a preference for this bowel preparation for future colonoscopies. CONCLUSION: The same-day SP + MC preparation showed high bowel-cleansing efficacy and satisfaction in Japanese patients without serious AEs.

Long-term Survival After Endoscopic Resection For Gastric Cancer: Real-world Evidence From a Multicenter Prospective Cohort.

BACKGROUND & AIMS: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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).

Long-Term Outcomes of Endoscopic Submucosal Dissection for Early Remnant Gastric Cancer: A Retrospective Multicenter Study.

INTRODUCTION: Favorable long-term outcomes of endoscopic submucosal dissection (ESD) for early remnant gastric cancer (ERGC) have been reported in single-center studies from advanced institutions. However, no studies have examined the long-term outcomes using a multicenter database. This study aimed to investigate the long-term outcomes of the aforementioned approach using a large multicenter database. METHODS: This retrospective multicenter cohort study included 242 cases with 256 lesions that underwent ESD for ERGC between April 2009 and March 2019 across 12 centers. We investigated the long-term outcomes of these patients with the Kaplan-Meier method, and the relationship between curability, additional treatment, or hospital category, and the survival time was evaluated using the log-rank test. RESULTS: During the median follow-up period of 48.4 months, the 5-year overall survival rate was 81.3%, and the 5-year gastric cancer-specific survival rate was 98.1%. The survival time of patients of endoscopic curability (eCura) C-2 without additional surgery was significantly shorter than the corresponding of patients of eCura A/B/C-1 and eCura C-2 with additional surgery. There was no significant difference in either overall survival or gastric cancer-specific survival rate between the high-volume and non-high-volume hospitals. CONCLUSION: The gastric cancer-specific survival of ESD for ERGC using a multicenter database was favorable. ESD for ERGC is widely applicable regardless of the hospital case volume. Management in accordance with the latest guidelines will lead to long-term survival.

Characteristics of Gastric Stasis due to Deformation after Endoscopic Submucosal Dissection in the Lower Part of the Stomach.

INTRODUCTION: Gastric stasis due to deformation occurs after endoscopic submucosal dissection in the lower part of the stomach. Endoscopic balloon dilation can improve gastric stasis due to stenosis; however, endoscopic balloon dilation cannot improve gastric stasis due to deformation. Furthermore, the characteristics of gastric stasis due to deformation are unknown. This study aimed to evaluate the characteristics of gastric stasis due to deformation after endoscopic submucosal dissection in the lower part of the stomach, focusing on the differences between stenosis and deformation. METHODS: We retrospectively reviewed 41 patients with gastric stasis after endoscopic submucosal dissection in the lower part of the stomach. We evaluated the characteristics of cases with gastric stasis due to deformation, such as the risk factors of deformation and the rate of deformation in each group with risk factors. RESULTS: Deformation was observed in 12% (5/41) of the patients with gastric stasis. All cases of deformation had a circumferential extent of the mucosal defect greater than 3/4. The number of cases with pyloric dissection was significantly lower in the deformation group than in the non-deformation group (0% vs. 72%; p = 0.004). The deformation group also had a significantly higher number of cases with angular dissection than the non-deformation group (100% vs. 17%; p < 0.001). Moreover, the deformation cases had a significantly larger specimen diameter (p < 0.001). Deformation was observed only in cases with angular and non-pyloric dissections. Deformation was not observed in cases with angular and pyloric dissections. CONCLUSIONS: All cases of gastric stasis due to deformation had a circumferential extent of the mucosal defect greater than 3/4. Deformation was also likely to occur in cases with a larger dissection that exceeded the angular region without pyloric dissection.

Risk-scoring system for predicting challenging cases of peroral endoscopic myotomy.

OBJECTIVES: Peroral endoscopic myotomy (POEM) is an effective treatment for esophageal motility disorders including achalasia and its variants. However, some surgeons have encountered challenging cases. This study aimed to develop a risk-scoring system to predict challenging cases of POEM. METHODS: Consecutive patients who underwent POEM between April 2015 and March 2020 at our hospital were included in this single-center retrospective study. Challenging cases of POEM were defined as patients with any of the following: (i) procedure time ≥90 min; (ii) mucosal perforation; (iii) pneumothorax; and (iv) major bleeding. A risk-scoring system for predicting challenging cases was developed based on multivariate logistic regression and internal validation was performed using the bootstrap method. Clinical usefulness was evaluated using a decision curve analysis. RESULTS: Of the 467 patients, 59 (12.6%) had challenging POEM. A risk-scoring system consisted of four variables: duration of symptoms ≥5 years (assigned score, 1 point), antithrombotics use (1 point), manometric diagnosis of achalasia variants (2 points), and dilation grade 3 (2 points). Our scoring system showed satisfactory discrimination (area under the receiver operating characteristic curve, 0.69; 95% confidence interval [CI] 0.61-0.77) and calibration (slope, 0.99; 95% CI 0.65-1.35). The decision curve analysis demonstrated its clinical usefulness. CONCLUSIONS: We established a risk-scoring system to predict challenging cases of POEM. This scoring system may aid the selection of patients who require treatment from experienced surgeons.

Assessment of predictive factors associated with the technical difficulty of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma: Japanese multicenter retrospective study.

OBJECTIVES: Endoscopic submucosal dissection (ESD) for superficial esophageal squamous cell carcinoma (ESCC) is performed for the treatment of lesions with varied backgrounds and factors. However, the predictive factors associated with the technical difficulty of ESD remain unknown in patients with varied lesions. Therefore, this study aimed to identify the predictive factors associated with the technical difficulty of ESD for ESCC using a retrospective cohort. METHODS: This multicenter, retrospective study was conducted in 10 hospitals in Japan. Consecutive patients who underwent esophageal ESD between January 2013 and December 2019 were enrolled. Lesions of subepithelial tumors, adenocarcinoma, and adenoma were excluded. Difficult lesions were defined as ESD requiring a long procedure time (≥120 min), perforation development, piecemeal resection, or discontinued ESD. In the present study, the clinical factors were assessed to identify the technical difficulty of ESD using univariate and multivariate analyses. RESULTS: Among 1708 lesions treated with esophageal ESD, eight subepithelial tumors, 44 adenocarcinomas, and two adenomas were excluded. Finally, 1505 patients with 1654 lesions were analyzed, and 217 patients with 217 lesions (13.1%) were classified as patients with difficult lesions. In multivariate analysis, the predictive factors associated with the technical difficulty of ESD were as follows: tumors with varices, tumors with diverticulum, antiplatelet use (discontinued), circumference of tumor (≥1/2), preoperative tumor size ≥30 mm, trainee, and nonhigh-volume center. CONCLUSION: This multicenter retrospective study identified the predictive factors associated with the technical difficulty of ESD for ESCC with varied backgrounds and factors.

Safety and efficacy of endoscopic submucosal dissection for superficial esophageal cancer with esophageal varices.

BACKGROUND: Heavy drinking is associated with esophageal cancer and esophageal varices. However, there are limited reports of endoscopic resection for esophageal cancer with esophageal varices. In this multicenter study, we clarified the safety and efficacy of endoscopic submucosal dissection for superficial esophageal cancer with esophageal varices. METHODS: In this multicenter, retrospective, observational study, patients underwent esophageal endoscopic submucosal dissection at 10 referral centers in Japan from January 2013 to December 2019. We analyzed characteristics including backgrounds and varices, treatment outcomes, and adverse events in cases with esophageal varices. RESULTS: A total of 1708 patients were evaluated, 27 (1.6%) of whom had esophageal varices. In patients with esophageal varices, the en bloc resection rate and R0 resection rate were 100% and 77.8%, respectively. Patients with esophageal varices had longer procedure times than patients without esophageal varices (p = 0.015). There was no significant difference in adverse events. There was no significant difference in procedure time and number of adverse events between patients who underwent pretreatment and those who did not. There was no significant difference in these outcomes for patients with lesions on varices compared to those without. Child-Pugh classification and location of the lesions also did not affect these outcomes. CONCLUSIONS: Esophageal cancer with esophageal varices could be treated endoscopically safely and effectively.

The risk scoring system for assessing the technical difficulty of endoscopic submucosal dissection in cases of remnant gastric cancer after distal gastrectomy.

BACKGROUND: Endoscopic submucosal dissection (ESD) for remnant gastric cancer (RGC) after distal gastrectomy (DG) is considered technically challenging due to the narrow working space, and severe fibrosis and staples from the previous surgery. Technical difficulties of ESD for RGC after DG have not been thoroughly investigated. This study aimed to develop and validate a risk-scoring system for assessing the technical difficulty of ESD for RGC after DG in a large multicenter cohort. METHODS: We investigated patients who underwent ESD for RGC after DG in 10 institutions between April 2008 and March 2018. A difficult case was defined as ESD lasting ≥ 120 min, involving piecemeal resection, or the occurrence of perforation during the procedure. A risk-scoring system for the technical difficulty of the procedure was developed based on multiple logistic regression analyses, and its performance was internally validated using bootstrapping. RESULTS: A total of 197 consecutive patients with 201 lesions were analyzed. There were 90 and 111 difficult and non-difficult cases, respectively. The scoring model consisted of four independent risk factors and points of risk scores were assigned for each as follows: tumor size > 20 mm: 2 points; anastomosis site: 2 points; suture line: 1 point; and non-expert endoscopist: 2 points. The C-statistics of the scoring system for technical difficulty was 0.72. CONCLUSIONS: We developed a validated risk-scoring model for predicting the technical difficulty of ESD for RGC after DG that can contribute to its safer and more reliable performance.

Guidelines for Colorectal Cold Polypectomy (supplement to "Guidelines for Colorectal Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection").

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.

Esophageal motility disorders missed during endoscopy.

BACKGROUND: Esophageal motility disorders are sometimes misdiagnosed on endoscopic examination. We aimed to identify the proportion of patients with esophageal motility disorders missed during endoscopy and their clinical characteristics. METHODS: Patients diagnosed with either disorder with esophagogastric junction outflow obstruction or major disorders of peristalsis using high-resolution manometry in our hospital from April 2015 to March 2021 were included in this study. Missed esophageal motility disorders were defined as patients with any endoscopic misdiagnosis such as normal esophagus or esophagitis within 1 year before the manometric diagnosis. We determined the proportion of missed esophageal motility disorders and identified independent predictors of missed esophageal motility disorders using multivariate analysis. RESULTS: A total of 41/273 esophageal motility disorders (15.0%; 95% confidence interval 11.3-19.7%) were missed during endoscopy within 1 year before manometric diagnosis. In the stepwise logistic regression analysis, the following variables were selected as independent variables for patients with missed esophageal motility disorders during endoscopy: non-dilated esophagus (odds ratio = 4.87, 95% confidence interval: 1.81-13.12, p = 0.002), the presence of epiphrenic diverticulum (odds ratio = 8.95, 95% confidence interval: 1.88-42.65, p = 0.006), the use of transnasal endoscopy (odds ratio = 4.71, 95% confidence interval: 1.59-13.92, p = 0.005), and the combined use of esophagram (odds ratio = 0.023, 95% confidence interval: 0.0025-0.20, p = 0.0008). CONCLUSIONS: Based on retrospective analysis, 15% of esophageal motility disorders were missed during endoscopy. Understanding the clinical characteristics of missed esophageal motility disorders could help improve endoscopic diagnoses.

Development of a preoperative risk-scoring system for predicting poor responders to peroral endoscopic myotomy.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) is an effective treatment for esophageal motility disorder. However, some people are poor responders who will probably need retreatments, such as endoscopic pneumatic dilation or re-POEM, and a scoring system for the prediction of poor responders preoperatively has not yet been established. We aimed to develop and validate a preoperative scoring system for predicting poor responders. METHODS: Overall, 244 patients who underwent POEM for esophageal motility disorders in our hospital from April 2015 to March 2019 were retrospectively included in this study. Poor responders were defined as patients with any of following: (1) Eckardt score ≥3 at 1-year follow-up, (2) endoscopic findings of food retention at 1-year follow-up, and (3) retreatments within 1 year after POEM. A risk-scoring system for poor responders was developed based on multiple logistic regression analysis, and its performance was internally validated using bootstrapping. RESULTS: Forty patients were diagnosed as poor responders at the 1-year follow-up. In the multivariate study, points for risk scores were assigned for 4 independent risk factors as follows: pretreatment Eckardt score (1-point increments), previous treatments (4 points), sigmoid-type esophagus (4 points), and esophageal dilation grade ≥II (4 points). The scoring system could predict an estimated risk for poor responders and provided satisfactory discrimination (area under the receiver operating characteristic curve, 0.78; 95% confidence interval, 0.68-0.88) and calibration (slope = 0.93; 95% confidence interval, 0.62-1.31). CONCLUSIONS: A validated risk-scoring system for predicting poor responders preoperatively was established; this system could be useful for selecting treatment strategies and postoperative surveillance.

Timing of pyloric stenosis and effectiveness of endoscopic balloon dilation after pyloric endoscopic submucosal dissection.

BACKGROUND AND AIM: There have been studies on risk factors for stenosis after pyloric endoscopic submucosal dissection (ESD). However, the most appropriate strategies for the management of cases with these risk factors have not been established. This study aimed to investigate post-ESD management by evaluating the timing of stenosis and the effectiveness of endoscopic balloon dilation (EBD) after pyloric ESD. METHODS: We retrospectively reviewed cases of pyloric ESD. We first reassessed risk factors for stenosis in multivariate analysis and receiver operating characteristic curve and defined patients with the identified risk factors as the risk group. The primary outcome was the timing of stenosis in the risk group assessed by the Kaplan-Meier method. RESULTS: We reviewed 159 cases with pyloric ESD and observed pyloric stenosis in 25 cases. Cases with circumferential mucosal defect ≥ 76% were identified as the risk group. The stenosis-free probability in the risk group was 97% (95% confidence interval [CI]: 79-100%), 94% (95% CI: 76-98%), and 85% (95% CI: 66-93%) on days 7, 14, and 21, respectively. It decreased every week thereafter and did not significantly change after day 56. Twenty-three stenosis cases, except for conservative improvement, including six whole circumferential pyloric ESD cases, were improved by EBD without complications. CONCLUSIONS: Post-ESD stenosis often developed from the third to the eighth week. In all pyloric ESD cases, including whole circumferential pyloric ESD cases, pyloric stenosis was improved following EBD without complications.

Feasibility and Safety of Endoscopic Submucosal Dissection for Recurrent Rectal Lesions that after Transanal Endoscopic Microsurgery: A Case Series.

OBJECTIVES: Recently, several studies have demonstrated the usefulness of endoscopic submucosal dissection (ESD) for residual or locally recurrent colorectal lesions after endoscopic treatment. However, the feasibility of ESD for recurrent rectal lesions after transanal endoscopic microsurgery (TEM) has not been fully investigated. In this study, we evaluated the feasibility and safety of ESD for recurrent rectal lesions after TEM. METHODS: The treatment outcomes of 10 lesions in 9 patients, who underwent ESD between January 2006 and March 2018 for recurrent rectal lesions after transanal endoscopic microsurgery, were evaluated. RESULTS: All lesions were successfully resected en bloc, and the R0 resection rate was 90%. The median size of the resected specimens and lesions (range) was 44 mm (21-70) and 27.5 mm (5-60), respectively. The pathological diagnoses included 4 adenomas and 6 cancerous lesions. The cancerous lesions included 5 cases of mucosal cancer and 1 case of superficial submucosal invasive cancer (depth of submucosal invasion <1,000 µm from the muscularis mucosae). No adverse events occurred. There was no recurrence during the follow-up period. CONCLUSIONS: ESD for recurrent rectal lesions after TEM by expert's hands appears to be safe and feasible.

Endoscopic Submucosal Dissection Using EndoTrac, a Novel Traction Device.

BACKGROUND: Endoscopic submucosal dissection (ESD) is recognized as a minimally invasive and curative treatment for superficial gastrointestinal (GI) cancers. However, ESD is still challenging and time-consuming with a high risk of adverse events such as bleeding and perforation. Various traction methods have been explored for maintaining good visualization of the submucosal layer during ESD. We developed a novel traction device (the EndoTrac) which can easily tie the thread and has the ability to change the towing direction. The aim of this study is to evaluate safety and feasibility of ESD using the EndoTrac for GI neoplasms. PATIENTS AND METHODS: We retrospectively analyzed 44 patients (45 lesions) with esophageal, gastric, duodenal, and colorectal neoplasms who had undergone ESD using the EndoTrac device between June 2018 and May 2019. Primary outcome measures were preparation time, procedural success using the EndoTrac device, and ease of ability to change towing direction. RESULTS: Mean preparation time was 2 (2-5) min in esophagus, 3 (1-5) min in stomach, 6 (5-9) min in duodenum, and 4 (2-8) min in colorectum. The procedural success rate was 100% (8/8) in esophagus, 100% (21/21) in stomach, 100% (4/4) in duodenum, and 100% (12/12) in colorectum. The rate of successful towing to both proximal and distal sides was 100% (8/8) in esophagus, 100% (21/21) in stomach, 0% (0/4) in duodenum, and 100% (12/12) in colorectum. CONCLUSIONS: Use of the EndoTrac device appears to be a feasible approach to ESD for GI neoplasms.

Endoscopic submucosal dissection involving the anal canal presents a risk factor for postoperative stricture.

BACKGROUND: Although postoperative strictures after endoscopic submucosal dissection (ESD) in the rectum are relatively rare, some rectal lesions require resection involving the anal canal, which is a narrow tract comprising squamous epithelium. To the best of our knowledge, no studies have investigated narrow anal canals when evaluating post-ESD strictures. This study aimed to evaluate the impact of resections involving the anal canal on postoperative stricture development. METHODS: Between April 2005 and October 2017, 707 rectal lesions were treated with ESD. We retrospectively investigated 102 lesions that required ≥ 75% circumferential resection. Risk factors for post-ESD stricture and, among patients with strictures, obstructive symptoms, and number of dilation therapies required were investigated. RESULTS: Post-ESD stricture occurred in 18 of 102 patients (17.6%). In the multivariate analysis, circumferential resection ≥ 90% and ESD involving the anal canal (ESD-IAC) were risk factors for postoperative strictures (P ≤ 0.0001 and 0.0115, respectively). Among the patients with strictures, obstructive symptoms were significantly related to anal strictures compared to rectal strictures (100% vs. 27.2%, P = 0.0041). Furthermore, the number of dilation therapies required was significantly greater among patients with anal strictures compared to those with rectal strictures (6.5 times vs. 2.7 times, P = 0.0263). CONCLUSION: Not only circumferential resection ≥ 90% but also ESD-IAC was a significant risk factor for the stricture after rectal ESD. Furthermore, anal strictures were associated with a significantly higher frequency of obstructive symptoms and larger number of required dilation therapies than were rectal strictures.

Development and validation of an endoscopic submucosal dissection video assessment tool.

BACKGROUND: Despite a need for assessment of endoscopic submucosal dissection (ESD) skills in order to track progress and determine competence, there is no structured measure of assessing competency in ESD performance. The present study aims to develop and examine validity evidence for an assessment tool to evaluate the recorded performance of ESD for gastric neoplasms. METHODS: The ESD video assessment tool (EVAT) was systematically developed by ESD experienced endoscopists. The EVAT consists of a 25-item global rating scale and 3-item checklist to assess competencies required to perform ESD. Five unedited videos were each evaluated by 2-blinded experienced ESD endoscopists to assess inter-rater reliability using intraclass correlation coefficients (ICC). Seventeen unedited videos in total were rated by 3 blinded experienced ESD endoscopists. Validity evidence for relationship to other variables was examined by comparing scores of inexperienced (fellows) and experienced endoscopists (attending staff), and by evaluating the relationship between the EVAT scores and ESD case experience. Internal consistency was evaluated using Cronbach's alpha. RESULTS: The inter-rater reliability for the total score was high at 0.87 (95% confidence interval 0.11 to 0.99). The total score [median, interquartile range (IQR)] was significantly different between the inexperienced (71, 63-77) and experienced group (95, 91-97) (P = 0.005). The total scores demonstrated high correlation with the number of ESD cases (Spearman's ρ = 0.79, P < 0.01). The internal consistency was 0.97. CONCLUSIONS: This study provides preliminary validity evidence for the assessment of video-recorded ESD performances for gastric neoplasms using EVAT.

Comparison of the safety and efficacy of peroral endoscopic myotomy between octogenarians and non-octogenarians.

OBJECTIVES: This study compared the safety and efficacy of peroral endoscopic myotomy for esophageal motility disorders between octogenarians and non-octogenarians. METHODS: This retrospective observational study recruited 321 patients (28 octogenarians and 293 non-octogenarians) who underwent peroral endoscopic myotomy from two institutions. Clinical success (postoperative Eckardt score ≤ 3), technical success (completion of gastric and esophageal myotomy), and perioperative adverse events were compared between octogenarians and non-octogenarians. Perioperative adverse events were classified into major and minor adverse events based on the International Peroral Endoscopic Myotomy Survey criteria and were subdivided into technical and non-technical adverse events according to the presence of a direct causal relationship with the procedure. RESULTS: There were no significant differences in the rates of clinical success 1 year after treatment (100% vs. 97.3%, P = 0.64) and technical success (100% vs. 99.7%, P = 0.91) between octogenarians and non-octogenarians. Octogenarians had a higher incidence of perioperative adverse events (28.6% vs. 10.2%, P = 0.00097), particularly major adverse events (25.0% vs. 3.0%, P < 0.0001). There were no significant differences in the incidence of minor adverse events (7.1% vs. 7.9%, P = 0.67). Although there was no difference in the incidence of technical adverse events (10.7% vs. 9.2%, P = 0.74), octogenarians had a significantly higher incidence of non-technical adverse events (17.9% vs. 1.0%, P = 0.0002). CONCLUSIONS: There were no significant differences in short-term clinical success and technical success between octogenarians and non-octogenarians. However, octogenarians showed a significantly higher incidence of perioperative adverse events, particularly in major adverse events and non-technical adverse events. Peroral endoscopic myotomy for octogenarians should be carefully applied.

Feasibility of laparoscopic endoscopic cooperative surgery for non-ampullary superficial duodenal neoplasms: Single-arm confirmatory trial.

OBJECTIVE: Laparoscopic endoscopic cooperative surgery for duodenal tumors (D-LECS) has been developed to prevent duodenal leakage by reinforcing the endoscopic submucosal dissection site. However, there has been no prospective trial showing the feasibility of D-LECS. Herein, we conducted a single-arm confirmatory trial to evaluate the safety of D-LECS for non-ampullary superficial duodenal neoplasms. METHODS: This prospective single-center single-arm confirmatory trial analyzed patients with non-ampullary superficial duodenal neoplasms who underwent D-LECS. The primary endpoint was the incidence of any postoperative leakage occurring on the duodenal wall within 1 month postoperatively. The planned sample size was 20 patients, considering a threshold of 28% and one-sided alpha value of 5%. RESULTS: Between January 2015 and September 2018, 20 eligible patients were enrolled. Sixteen tumors were located in the second portion, three in the first portion, and one in the third portion of the duodenal region. The median operative time was 225 (134-361) min and the median blood loss was 0 (0-150) mL. Curative resection (R0) with negative margins was achieved in 19 cases. One case of postoperative leakage and one case of bleeding of grade 2 according to the Clavien-Dindo classification were observed in this series. The median duration of postoperative hospital stay was 9 (5-12) days. No local recurrence was observed in any patient during the median follow-up of 15.0 (12.0-38.0) months. CONCLUSIONS: This trial confirmed the safety and feasibility of D-LECS for non-ampullary superficial duodenal neoplasms with respect to the low incidence of postoperative duodenal leakage.