Randomised controlled, patient-blinded, multicentre, superiority trial to evaluate the efficacy of the line-attached sheath-type traction device for endoscopic submucosal dissection in patients with superficial gastric neoplasms.

INTRODUCTION: EndoTrac is a line-attached sheath-type traction device that enables us to control the direction and the force of traction during endoscopic submucosal dissection (ESD). The efficacy of EndoTrac for gastric ESD has not been fully verified. METHODS AND ANALYSIS: The G-Trac study is a multicentre (nine general hospitals and two university hospitals in Japan) collaborative trial assessing the efficacy of EndoTrac for gastric ESDs. Patients with superficial gastric neoplasms will be enrolled and randomly assigned to undergo either conventional ESD or EndoTrac ESD. Allocation will be stratified according to tumour location, operator experience and tumour diameter at an allocation rate of 1:1. The type of endoknife used will be confirmed before randomisation. The primary outcome, procedure time, will be compared between the groups in both intention-to-treat and per-protocol analyses using the Wilcoxon rank sum test. The efficacy-related, safety-related and device-related outcomes will be assessed in the secondary analysis. The planned sample size of the 142 patients in the two groups will enable us to detect a difference with a power of 80% by using the Wilcoxon rank sum test, assuming an effect size of 0.54, asymptotic relative efficiency of 0.864 and a two-sided type 1 error rate of 5%. ETHICS AND DISSEMINATION: This trial was approved by the certified review board of Kobe University (22 December 2022). The results from this trial will be disseminated through peer-review journals, presentations at national and international conferences, and data sharing with other researchers. TRIAL REGISTRATION NUMBER: jRCT1052220166.

Usefulness of three-dimensional imaging in a flexible endoscopic surgery platform with multi-degrees-of-freedom articulating devices.

BACKGROUND AND AIMS: Recent studies on endoscopic submucosal dissection have aimed to reduce the difficulty of the procedure by using multi-degrees-of-freedom articulating devices. In this study, we evaluated the usefulness of adding three-dimensional (3D) video imaging into simulated endoscopic submucosal dissection tasks using multi-degrees-of-freedom devices. METHODS: We designed an endoscopic platform with a 3D camera and two multi-degrees-of-freedom devices. Four ex vivo bench tasks were created, and a crossover study comparing 2D and 3D conditions was conducted on 15 volunteers. In each task, performance such as procedure time and accuracy were objectively evaluated. Additionally, a comprehensive visual analogue scale questionnaire was conducted. RESULTS: In the tasks simulating submucosal flap grasping, marking, and full-area incision, the use of 3D imaging significantly improved the speed and accuracy of the multi-degrees-of-freedom device manipulation (p < .01). No significant differences were observed in the task that simulated the dissection procedure. Furthermore, it appears that the accuracy of recognizing curved surfaces may be reduced in the 3D environment. Operators reported subjective increases in recognizability and operability with the 3D camera, along with an increase in asthenopia (p < .01). CONCLUSIONS: 3D vision improves the technical accuracy of certain simulated multi-degrees-of-freedom endoscopic submucosal dissection tasks and subjectively improved operating conditions, at the cost of increased eye strain.

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.

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.

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.

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.

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.

Clinicopathological Features and the Prevalence of Oxyntic Gland Neoplasm: A Single-center Retrospective Study.

Objective We explored the clinicopathological characteristics and disease frequency of oxyntic gland neoplasms (OGNs). Methods We retrospectively evaluated the data of patients pathologically diagnosed with OGN at an internal medicine clinic. Patients A total of 13,240 upper gastrointestinal endoscopies were performed on 7,488 patients between December 1, 2017, and March 31, 2021. Results We identified 27 patients with 30 histopathologically confirmed OGNs, yielding a disease frequency of 0.36% (27/7,488). Furthermore, multiple simultaneous lesions were found in 3 of 27 patients (11%). One (3.3%) of the 30 lesions was present in the antrum, whereas the remaining lesions occurred in the body of the stomach. Nine (33%) of the 27 patients had no history of Helicobacter pylori infection, whereas the remaining 18 (67%) were either currently or had been previously infected. Nevertheless, 27/30 lesions (90%) still occurred in non-atrophied regions. After endoscopic treatment, a histopathological examination of the resected specimens revealed submucosal infiltration in 8 (44%) of the 18 lesions; however, none of the lesions showed submucosal desmoplasia. For all patients with submucosal involvement, only observation was performed. There were no recurrent lesions found on follow-up. Conclusion The period prevalence of OGN was 0.36%, which is much higher than previously reported. The discovery of a small submucosal appearing lesion with a faded yellow or white color and dilated microvasculature, especially in a non-atrophic area of the stomach, should raise suspicion for an OGN, which can be endoscopically managed.

Speech Recognition System Generates Highly Accurate Endoscopic Reports in Clinical Practice.

Objective Endoscopic reports are conventionally written at the end of each procedure, and the endoscopist must complete the report from memory. To make endoscopic reporting more efficient, we developed a new speech recognition (SR) system that generates highly accurate endoscopic reports based on structured data entry. We conducted a pilot study to examine the performance of this SR system in an actual endoscopy setting with various types of background noise. Methods In this prospective observational pilot study, participants who underwent upper endoscopy with our SR system were included. The primary outcome was the correct recognition rate of the system. We compared the findings generated by the SR system with the findings in the handwritten report prepared by the endoscopist. The initial correct recognition rate, number of revisions, finding registration time, and endoscopy time were also analyzed. Results Upper endoscopy was performed in 34 patients, generating 128 findings of 22 disease names. The correct recognition rate was 100%, and the median number of revisions was 0. The median finding registration time was 2.57 [interquartile range (IQR), 2.33-2.92] seconds, and the median endoscopy time was 234 (IQR, 194-227) seconds. Conclusion The SR system demonstrated high recognition accuracy in the clinical setting. The finding registration time was extremely short.

Laparoscopic Endoscopic Cooperative Surgery Using Open-Window Suturing Technique for Treating Non-ampullary Superficial Duodenal Neoplasms Located on the Pancreatic Side.

PURPOSE: No study has focused on the safety and feasibility of our previously developed open-window suturing technique to close mucosal defects on the pancreatic side after endoscopic submucosal dissection from the opened duodenal wall. This study aimed to evaluate the safety and usefulness of laparoscopic endoscopic cooperative surgery for duodenal tumors for treating superficial non-ampullary duodenal epithelial tumors on the pancreatic side of the duodenum. METHODS: This retrospective study included 61 consecutive patients who underwent surgery during August 2014-November 2021. After dissection when the tumor was on the pancreatic side, we sutured the mucosal defect from the opened duodenal wall. A preoperative endoscopic pancreatic stent was placed for tumors within 1 cm of the ampulla of Vater. The surgical outcomes were compared between tumors on the pancreatic and non-pancreatic sides. RESULTS: There were 27 and 34 patients with tumors on the pancreatic and non-pancreatic sides, respectively. The patient characteristics were similar. Preoperative pancreatic stents were placed in four patients in the pancreatic side group. The median operative time was significantly longer on the pancreatic side than in the non-pancreatic side group (241 vs. 209 min, P = 0.02). In one patient in the pancreatic side group, an intraoperative injury of the ampulla of Vater was successfully treated with intraoperative management. There were no significant differences in the incidence of postoperative grade II or higher complications between the groups. CONCLUSIONS: Laparoscopic endoscopic cooperative surgery for duodenal tumors for treating superficial non-ampullary duodenal epithelial tumors on the pancreatic side is safe and feasible.

Feasibility and safety of endoscopic submucosal dissection for lesions in proximity to a colonic diverticulum.

BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) for diverticulum-associated colorectal lesions is generally contraindicated because of the high risk of perforation. Several studies on patients with such lesions treated with ESD have been reported recently. However, the feasibility and safety of ESD for lesions in proximity to a colonic diverticulum (D-ESD) have not been fully clarified. The aim of this study was to evaluate the feasibility and safety of D-ESD. METHODS: D-ESD was defined as ESD for lesions within approximately 3 mm of a diverticulum. Twenty-six consecutive patients who underwent D-ESD were included. Two strategic approaches were used depending on whether submucosal dissection of the diverticulum-related part was required (strategy B) or not (strategy A). Treatment outcomes and adverse events associated with each strategy were analyzed. RESULTS: The en bloc resection rate was 96.2%. The rates of R0 and curative resection in strategies A and B were 80.8%, 73.1%, 84.6%, and 70.6%, respectively. Two cases of intraoperative perforation and one case of delayed perforation occurred. The delayed perforation case required emergency surgery, but the other cases were managed conservatively. CONCLUSION: D-ESD may be a feasible treatment option. However, it should be performed in a high-volume center by expert hands because it requires highly skilled endoscopic techniques.

The importance of pH adjustment for preventing fibrin glue dissolution in the stomach: an in vitro study.

Combined use of fibrin glue and polyglycolic acid (PGA) sheets has attracted attention as a preventive measure for complications associated with endoscopic submucosal dissection. However, fibrin glue is a protein that may be dissolved by gastric acid. We evaluated the effect of artificial gastric acid on fibrin clot. The dissolution time of three layers of fibrin glue with PGA sheets was measured in five groups (pH 1.2, 2.0, 4.0, 5.5, and 6.0 with pepsin). Measurements of three samples per group were made. The mean number of the remaining layers at each measurement point was observed for 168 h. The time to complete dissolution of the three layers of fibrin gel in the three samples was 2.5 h at pH 1.2, 5 h at pH 2.0, 24 h at pH 4.0, and 48 h and 6 h at pH 5.5. In order to maintain fibrin glue in the stomach for a long period, there was a need to avoid pepsin activation secondary to acidification of gastric juice. The use of strong antacids is recommended.

Clinical Impact of Different Reconstruction Methods on Remnant Gastric Cancer at the Anastomotic Site after Distal Gastrectomy.

BACKGROUND/AIMS: The anastomotic site after distal gastrectomy is the area most affected by duodenogastric reflux. Different reconstruction methods may affect the lesion characteristics and treatment outcomes of remnant gastric cancers at the anastomotic site. We retrospectively investigated the clinicopathologic and endoscopic submucosal dissection outcomes of remnant gastric cancers at the anastomotic site. METHODS: We recruited 34 consecutive patients who underwent endoscopic submucosal dissection for remnant gastric cancer at the anastomotic site after distal gastrectomy. Clinicopathology and treatment outcomes were compared between the Billroth II and non-Billroth II groups. RESULTS: The tumor size in the Billroth II group was significantly larger than that in the non-Billroth II group (22 vs. 19 mm; p=0.048). More severe gastritis was detected endoscopically in the Billroth II group (2 vs. 1.33; p=0.0075). Moreover, operation time was longer (238 vs. 121 min; p=0.004) and the frequency of bleeding episodes was higher (7.5 vs. 3.1; p=0.014) in the Billroth II group. CONCLUSION: Compared to remnant gastric cancers in non-Billroth II patients, those in the Billroth II group had larger lesions with a background of severe remnant gastritis. Endoscopic submucosal dissection for remnant gastric cancers in Billroth II patients involved longer operative times and more frequent bleeding episodes than that in patients without Billroth II.

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.

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.

Fibrin glue: Novel submucosal injection agent for endoscopic submucosal dissection.

Background and study aims Adequate mucosal elevation by submucosal injection is crucial for patient safety and efficiency during endoscopic submucosal dissection (ESD). This study aimed to evaluate the efficacy of fibrin glue (FG) as a long-lasting submucosal injection agent and to evaluate the technical feasibility of FG injection for ESD. Materials and methods To compare the capabilities of different agents in maintaining submucosal evaluation, we injected FG, hyaluronic acid solution, and normal saline into the porcine gastric specimen that was incised into approximately 5 × 5 cm squares. Then, we measured the height of submucosal elevations over time. Moreover, three hypothetical lesions from the resected porcine stomach underwent ESD with FG injection. Thereafter, we conducted macroscopic and histopathologic analyses. Results FG maintained the greatest submucosal elevation among all the injection agents. Three ESD procedures were performed with en bloc resection. Both macroscopic and histopathologic findings showed a thick FG clot on the ulcers. Conclusions The FG solution can be potentially used as an ESD submucosal injection agent in an in vitro model.

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.