Endoscopic Submucosal Dissection In Patients Research Articles

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

IntroductionEndoTrac 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...

Efficacy of prophylactic clip closure in reducing the risk of delayed bleeding after colorectal endoscopic submucosal dissection in patients on anticoagulant therapy: Multicenter prospective study.

The high rate of delayed bleeding after colorectal endoscopic submucosal dissection (ESD) in patients undergoing anticoagulant therapy remains a problem. Whether prophylactic clip closure reduces the rate of delayed bleeding in these patients is unclear. This study aimed to evaluate the efficacy of prophylactic clip closure in patients receiving anticoagulants. This multicenter prospective interventional trial was conducted at nine referral centers in Japan. Patients regularly taking anticoagulants, including warfarin potassium or direct oral anticoagulants, and undergoing ESD for colorectal neoplasms were enrolled. The discontinuation of anticoagulants was minimized according to recent guidelines. After the ESD, post-ESD ulcers were prophylactically closed using endoclips. The primary end-point was the incidence of delayed bleeding. The sample size was 45 lesions, and prophylactic clip closurewas considered effective when the upper limit of the 90% confidence interval (CI) for delayed bleeding did not exceed 20%. Forty-five lesions were used, and three were excluded. Complete closure was achieved in 41/42 lesions (97.6%). The overall delayed bleeding rate was low, at 4.9% (2/41; 90% [CI] 0.8-14.5), which was significantly lower than that at the prespecified threshold of 20% (P = 0.007). The median closure procedure time was 17 min, and the median number of clips was nine. No massive delayed bleeding requiring transfusion, interventional radiology, or surgery was observed, and no thromboembolic events were observed. Prophylactic clip closure may reduce the risk of delayed bleeding following colorectal ESD in patients receiving anticoagulants. UMIN Clinical Trial Registry (UMIN000036734).

Comparison of hemostatic ability between spray coagulation and forced coagulation modes in endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for multicenter randomized controlled trial (Spray-G trial)

BackgroundEndoscopic submucosal dissection (ESD) is the standard treatment for early gastric neoplasms (EGN). Controlling intraoperative bleeding is crucial for ensuring safe and reliable procedures. ESD using the spray coagulation mode (SCM-ESD) has been developed to control bleeding more effectively than ESD using the conventional forced coagulation mode (FCM-ESD). This study aims to compare the hemostatic efficacies of SCM-ESD and FCM-ESD.MethodsThis multicenter, prospective, parallel, randomized, open-label superiority trial will be conducted in five Japanese institutions. Patients with a preoperative diagnosis of intramucosal EGC will be randomized to undergo either SCM-ESD or FCM-ESD. The primary outcome measure is the completion of ESD with an electrosurgical knife alone, without the use of hemostatic forceps. Secondary outcomes include the number and duration of hemostasis using hemostatic forceps, procedure time, curability, and safety. A total of 130 patients will be enrolled in this study.DiscussionThis trial will provide evidence on the hemostatic efficacy of SCM-ESD compared with FCM-ESD in patients with intramucosal EGN, potentially improving the safety and reliability of ESD procedures.Trial registrationThe trial has been registered at the University Hospital Medical Information Network Clinical Trials Registration (UMIN-CTR) as UMIN000040518. The reception number is R000054009.

Precutting endoscopic band ligation-assisted resection versus endoscopic submucosal dissection in patients with small gastric submucosal tumors originating from the muscularis propria: study protocol of a randomized controlled trial

BackgroundThe management of small gastric submucosal tumors (SMTs) originating from the muscularis propria layer (SMT-MPs) remains a subject of debate. Endoscopic submucosal dissection (ESD) is currently considered the optimal treatment for resection. However, high expenses, complex procedures, and the risk of complications have limited its application. Our previously proposed novel operation, precutting endoscopic band ligation (precutting EBL), has been demonstrated in a long-term, single-arm study to be an effective and safe technique for removing small gastric SMTs. However, the absence of a pathological examination and the potential for delayed perforation have raised concerns. Thus, we modified the precutting EBL by adding endoscopic resection to the snare after ligation and closure, yielding the precutting endoscopic band ligation-assisted resection (precutting EBLR). Moreover, the initial pilot study confirmed the safety and efficacy of the proposed approach and we planned a randomized controlled trial (RCT) to further validate its clinical feasibility.MethodsThis was a prospective, single-center, open-label, parallel group, and randomized controlled trial. Approximately 40 patients with SMT-MPs will be included in this trial. The patients included were allocated to two groups: ESD and precutting EBLR. The basic clinical data of the patients were collected in detail. To better quantify the difference between ESD and precutting EBLR, the primary outcome was set as the operation duration. The secondary outcomes included total operation cost and hospitalization, intraoperative adverse events, and postoperative recurrence. The primary outcome was tested for superiority, while the secondary outcomes were tested for noninferiority. SPSS is commonly used for statistical analysis.DiscussionThis study was designed to validate the feasibility of a novel operation for removing gastric SMT-MPs. To intuitively assess this phenomenon, the operation durations of precutting EBLR and ESD were compared, and other outcomes were also recorded comprehensively.Trial registrationChinese Clinical Trial Registry ChiCTR2200065473. Registered on November 5, 2022.

Comparison of clinical outcomes and prognosis between surgery and endoscopic submucosal dissection in patients with synchronous multifocal early gastric cancer

BackgroundSynchronous multiple early gastric cancer (SMEGC) refers to the simultaneous occurrence of two or more malignant cancer lesions in the stomach. For patients with multiple early gastric carcinomas, the choice of appropriate treatment remains controversial. This study is dedicated to comparing the clinical outcomes and prognosis of patients with SMEGC who underwent endoscopic submucosal dissection (ESD) or gastrectomy.MethodsA total of 180 patients with more than one malignant cancer lesion in the stomach who had received gastrectomy or ESD between 2012 and 2021 were retrospectively evaluated to determine their clinical outcomes and prognosis. Univariate and multivariate logistic regression were utilized to identify risk factors for tumor recurrence.ResultsOver the 57.5 months median follow-up period for the 140 enrolled cases, tumor recurrence occurred in 8 (12%) in the ESD group but only 1 (1%) in the surgery group. Relapse-free survival (RFS) was higher in the surgery group (p = 0.023) in all cases; however, there was no significant difference in Overall survival (OS, p = 0.772). Complications were significantly higher in the surgery group than in the ESD group, but fewer in the radical distal gastrectomy group. Multivariate regression analysis revealed that ESD(p = 0.034), the main lesion size > 2 cm(p = 0.019), and undifferentiated tumor(p = 0.022) were independent risk factors for tumor recurrence.ConclusionsFor the treatment of simultaneous multifocal early gastric cancer, ESD has a good short-term effect and higher quality of life. However, ESD has a higher risk of recurrence than surgery. And we found that the partial gastrectomy appears to be considered as adequate treatment for some SMEGC patients.

Clinical Outcome of Endoscopic Submucosal Dissection for Papillary Type Early Gastric Cancer: A Multicenter Study.

Papillary adenocarcinoma is classified to differentiated-type gastric cancer and is indicated for endoscopic submucosal dissection. However, due to its rare nature, there are limited studies on it. The purpose of this study was to determine the outcome of endoscopic submucosal dissection in patients with papillary-type early gastric cancer and to find the risk factors of lymph node metastasis. Patients diagnosed with papillary-type early gastric cancer at eight medical centers, who underwent endoscopic submucosal dissection or surgical treatment, were retrospectively reviewed. The clinical results and long-term outcomes of post-endoscopic submucosal dissection were evaluated, and the risk factors of lymph node metastasis in the surgery group were analyzed. One-hundred and seventy-six patients with papillary-type early gastric cancer were enrolled: 44.9% (n=79) in the surgery group and 55.1% (n=97) in the endoscopic submucosal dissection group. As a result of endoscopic submucosal dissection, the en bloc resection and curative resection rates were 91.8% and 86.6%, respectively. The procedure-related complication rate was 4.1%, and local recurrence occurred in 3.1% of patients. Submucosal invasion (odds ratio, 3.735; 95% confidence interval, 1.026 to 12.177; p=0.047) and lymphovascular invasion (odds ratio, 7.636; 95% confidence interval, 1.730 to 22.857; p=0.004) were the risk factors of lymph node metastasis in papillary-type early gastric cancer patients. The clinical results of endoscopic submucosal dissection in papillary-type early gastric cancer were relatively favorable, and endoscopic submucosal dissection is considered safe if appropriate indications are confirmed by considering the risk of lymph node metastasis.

Usefulness of the aldehyde breath test for predicting metachronous recurrence in patients with esophageal squamous cell carcinoma and hypopharyngeal squamous cell carcinoma.

The rate of metachronous recurrence after endoscopic submucosal dissection for early-stage esophageal squamous cell carcinoma and hypopharynx squamous cell carcinoma is as high (10-15%). The acetaldehyde breath test may detect acetaldehyde dehydrogenase 2 gene polymorphisms. Therefore, we evaluated its usefulness in assessing metachronous recurrence in patients with esophageal squamous cell carcinoma and hypopharynx squamous cell carcinoma. A total of 76 patients underwent endoscopic submucosal dissection for esophageal squamous cell carcinoma and hypopharynx squamous cell carcinoma and were followed up for at least 3years (non-recurrence group: 52 patients; recurrence group: 24 patients). The risk factors for carcinogenesis were compared between the recurrence and non-recurrence groups, and the acetaldehyde-to-ethanol ratio was assessed. The cutoff acetaldehyde-to-ethanol ratio that correlated with recurrence was established, and the cumulative recurrence rate was evaluated. The recurrence group had a higher acetaldehyde-to-ethanol ratio, daily alcohol consumption, and Lugol-voiding lesion grade than the non-recurrence group in the univariate analysis. The cutoff acetaldehyde-to-ethanol ratio for recurrence was 28.1 based on the receiver operating characteristic curve. The multivariate analysis revealed an acetaldehyde-to-ethanol ratio of > 28.1 and a Lugol-voiding lesion grade associated with carcinogenesis. Patients with an acetaldehyde-to-ethanol ratio of ≥ 28.1 had a significantly high recurrence rate using the Kaplan-Meier method. The acetaldehyde-to-ethanol ratio detected using the acetaldehyde breath test could be a novel biomarker of metachronous recurrence after endoscopic submucosal dissection in patients with esophageal squamous cell carcinoma and hypopharynx squamous cell carcinoma. UMIN000040615.

Predictors of severe submucosal fibrosis during endoscopic submucosal dissection in patients with ulcerative colitis: Retrospective cohort study.

Severe submucosal fibrosis is a crucial technical difficulty encountered during endoscopic submucosal dissection (ESD) in patients with ulcerative colitis (UC). We aimed to identify predictors of severe submucosal fibrosis in patients with UC. We retrospectively included 55 tumors resected using ESD from 48 consecutive patients with UC. We analyzed the clinicopathological characteristics and treatment outcomes between the F0/1 (none to mild submucosal fibrosis) group (n = 28) and F2 (severe submucosal fibrosis) group (n = 27). No significant difference was found between the F0/1 and F2 groups in en bloc resection rate (100% vs. 96%, P = 0.49), the R0 resection rate (100% vs. 93%, P = 0.24), and the dissection speed (0.18 vs. 0.13 cm2 /min, P = 0.07). Intraoperative perforation was more common in the F2 group (30%) than in the F0/1 group (8%; P = 0.01). Multivariable analysis showed that a longer duration of UC (≥10 years; odds ratio [OR] 6.11; 95% confidence interval [CI] 1.20-31.03; P = 0.03) and scarring of background mucosa of the tumor (OR 39.61; 95% CI 3.91-400.78; P < 0.01) were independent predictors of severe submucosal fibrosis. Long UC duration and scarring background mucosa were predictors of severe submucosal fibrosis associated with perforation during ESD.

Systemic immune-inflammation index in predicting non-curative resection of endoscopic submucosal dissection in patients with early gastric cancer.

Although endoscopic submucosal dissection (ESD) is considered standard treatment for early gastric cancer (EGC), patients with non-curative resection (NCR) of ESD may still require gastrectomy. The systemic immune-inflammation index (SII) showed great potential in predicting the prognosis of gastric cancer patients. This study aims to investigate the predictive validity of SII of NCR in EGC patients. We reviewed data from EGC patients who underwent ESD in the past. The relationship between SII and clinicopathologic features was investigated. We used Receiver operating characteristic curves to compare the predictive values of NCR between SII and other inflammation indices. Binary logistic analysis was used to identify independent risk factors for NCR. These factors were then used to construct a predictive nomogram. SII was associated with larger tumor size, male gender, older age, submucosal invasion, and a greater risk of NCR. SII showed better predictivity of NCR than platelet-to-lymphocyte ratio (PLR) and neutrophil-to-lymphocyte ratio (NLR). SII [odds ratio (OR) = 1.003, P = 0.001], NLR (OR = 1.520, P = 0.029), PLR (OR = 1.009, P = 0.010), upper stomach tumors (OR = 16.393, P < 0.001), poorly differentiated type (OR = 29.754, P < 0.001), ulceration (OR = 4.814, P = 0.001), and submucosal invasion (OR = 48.91, P < 0.001) were independent risk factors for NCR. The nomogram model based on these factors exhibited superior concordance and accuracy. SII could be considered a simple and effective predictor of NCR of ESD in EGC patients.

Endoscopic submucosal dissection for papillary early gastric carcinoma: Insights from a large-scale analysis of post-gastrectomy pathology specimens.

Gastric papillary adenocarcinoma is considered a differentiated adenocarcinoma in the current endoscopic submucosal dissection indication guidelines. However, the safety of endoscopic submucosal dissection remains controversial. Currently, data regarding which papillary early gastric cancer should be considered for endoscopic submucosal dissection are unavailable. Thus, the aim of this study was to investigate lymph node metastasis and the safety of endoscopic submucosal dissection in patients with papillary early gastric cancer. This observational study recruited 4264 consecutive patients with early gastric cancer who underwent curative gastrectomy between October 2000 and December 2017 at the National Cancer Center, Korea. Of these, 45 had pathologically confirmed papillary early gastric cancer, 2106 had differentiated non-papillary early gastric cancer, and 2113 had undifferentiated early gastric cancer. Logistic regression analysis was performed to identify risk factors for lymph node metastasis. Mucosal tumors were less common in papillary early gastric cancer (37.9%) than in differentiated non-papillary early gastric cancer (48.8%) and undifferentiated early gastric cancer (60.4%) (both P < .001). Lymph node metastasis was more common in papillary early gastric cancer (20.0%) than in differentiated non-papillary early gastric cancer (9.2%) and undifferentiated early gastric cancer (11.7%; both P < .001). In multivariate analysis, non-mixed-type papillary early gastric cancer showed marginally increased odds of lymph node metastasis than differentiated early gastric cancer (odds ratio [OR]: 2.5, 95% confidence interval [CI]: 1.0-6.3). Rates of lymph node metastasis (1/10, 10%) and angiolymphatic invasion (2/10, 20%) for papillary early gastric cancer meeting expanded criteria were higher than those for other histology types meeting endoscopic submucosal dissection absolute or expanded criteria (P = .03 and P < .001, respectively). Endoscopic submucosal dissection should be considered carefully for papillary early gastric cancer, especially if it meets expanded endoscopic submucosal dissection indications since it is associated with high rates of submucosal invasion and lymph node metastasis.

Endoscopic Submucosal Dissection in Patients with Early Gastric Cancer in the Remnant Stomach.

Endoscopic submucosal dissection (ESD) in patients with early gastric cancers (EGCs) in the remnant stomach is technically difficult, owing to the limited space and fibrosis under the suture lines and anastomoses. Conversely, ESD for patients with EGCs in the remnant stomach is less invasive and provides better quality of life than completion total gastrectomy. To clarify the effectiveness and safety of ESD, we reviewed the medical records of patients with EGCs in the remnant stomach who underwent ESD between July 2006 and October 2020 at our institution. All identified patients were included in the analysis. Of 25 patients with 27 lesions, the en bloc and R0 resection rates were 88.9% and 85.2%, respectively. Neither perforation nor postoperative bleeding was observed. During a median follow-up period of 48 (range, 5–162) months, the 5-year overall survival rate was 71.0%, whereas the 5-year cause-specific survival rate was 100%. No obvious differences in the outcomes of procedures with suture line involvement and without suture line or anastomosis involvement were noted. In conclusion, ESD was effective and safe in patients with EGCs in the remnant stomach despite the suture line involvement.

Prediction of Esophageal Stricture after Endoscopic Submucosal Dissection in Patients with Early Esophageal Cancer

BackgroundEndoscopic submucosal dissection (ESD) treatment of early esophageal cancer is effective and safe. It is currently the first-line treatment for early esophageal cancer. However, a common side effect is the development of esophageal strictures after ESD. This study was designed to identify the risk factors for esophageal stricture development and to predict its occurrence after ESD. MethodsIn this retrospective study, 150 consecutive patients with early esophageal cancer treated with ESD at Daping Hospital, Chongqing, were enrolled between January 2016 and December 2020. Data on patient demographics, esophageal tumor characteristics, procedure-related factors, and postoperative situations were collected. We identified independent risk factors of esophageal stricture formation using univariate analysis and multivariate logistic regression. The predictive probability was obtained after multivariate logistic analysis. In addition, patients were divided into six groups based on these risk factors and the rate of esophageal stricture in each group was analyzed. ResultsThe postoperative esophageal stricture rate was 14% (21/150). Tumor location (OR = 5.655, 95% CI: 1.245–25.691, P = 0.025) and circumferential resection range (OR = 16.113, 95% CI: 4.294–60.466, P < 0.001) are independent risk factors for the development of esophageal strictures. According to predictive probability analysis and the rates of stricture in six groups, we developed a possible flow chart to predict stricture formation. ConclusionsTumor location and circumferential resection range are reliable risk factors to predict the occurrence of esophageal strictures. Our prediction flow chart suggests that tumors with a circumferential resection range of 1/2–3/4 and located above the upper thoracic segment or a circumferential resection range of > 3/4 have a high risk of postoperative stricture. Thus, timely and effective preventive measures should be taken in these patients following ESD.

Postoperative Bleeding Risk after Gastric Endoscopic Submucosal Dissection in Patients Receiving a P2Y12 Receptor Antagonist.

The safety of gastric endoscopic submucosal dissection (ESD) in users of a P2Y12 receptor antagonist (P2Y12RA) under current guidelines has not been verified. Patients treated by gastric ESD at Okayama University Hospital between January 2013 and December 2020 were registered. The postoperative bleeding rates of patients (group A) who did not receive any antithrombotic drugs; patients (group B) receiving aspirin or cilostazol monotherapy; and P2Y12RA users (group C) those on including monotherapy or dual antiplatelet therapy were compared. The risk factors for post-ESD bleeding were examined in a multivariate analysis of patient background, tumor factors, and antithrombotic drug management. Ultimately, 1,036 lesions (847 patients) were enrolled. The bleeding rates of group B and C were significantly higher than that of group A (p=0.012 and p<0.001, respectively), but there was no significant difference between group B and C (p=0.11). The postoperative bleeding rate was significantly higher in dual antiplatelet therapy than in P2Y12RA monotherapy (p=0.014). In multivariate analysis, tumor diameter ≥12 mm (odds ratio [OR], 4.30; 95% confidence interval [CI], 1.99 to 9.31), anticoagulant use (OR, 4.03; 95% CI, 1.64 to 9.86), and P2Y12RA use (OR, 3.40; 95% CI, 1.07 to 10.70) were significant risk factors for postoperative bleeding. P2Y12RA use is a risk factor for postoperative bleeding in patients who undergo ESD even if receiving drug management according to guidelines. Dual antiplatelet therapy carries a higher risk of bleeding than monotherapy.

Outcomes of endoscopic submucosal dissection in patients who develop metachronous superficial esophageal squamous cell carcinoma close to a post-endoscopic submucosal dissection scar.

The presence of post-endoscopic submucosal dissection (ESD) scars renders complete metachronous superficial esophageal squamous cell carcinoma resection difficult. We aimed to identify the risk factors for incomplete resection of metachronous esophageal squamous cell carcinoma close to the post-ESD scar by ESD. We enrolled patients who developed post-ESD superficial esophageal squamous cell carcinoma at Hiroshima University Hospital between January 2006 and March 2020. We analyzed the outcomes and risk factors of incomplete resection between patients whose lesions were close to (close-to group) and away from (away-from group) the post-ESD scar. We included 111 patients with 212 lesions. The close-to group had a significantly lower complete resection rate (88.6% [62/70] vs. 98.6% [69/70], p = 0.033), longer procedure time (80.2 ± 47.2min vs. 60.4 ± 29.3min, p < 0.01), higher proportion of lesions with severe fibrosis (72.9% [51/70] vs. 5.7% [4/70], p < 0.01), and higher intraoperative bleeding rate (78.6% [55/70] vs. 60.0% [42/70], p = 0.027) than the away-from group. There was no significant difference in the rate of local recurrence, muscle injury, perforation, and stenosis as well as the pathological tumor depth between the groups. Of the 92 lesions in the close-to group, the proportion of lesions located on the oral side of the post-ESD scar significantly affected the incidence of incomplete resection (91.7% [11/12] vs. 53.8% [43/80], p = 0.013). Complete resection was more difficult for lesions located on the oral side of the post-ESD scar.

Machine Learning Improves the Prediction Rate of Non-Curative Resection of Endoscopic Submucosal Dissection in Patients with Early Gastric Cancer

Simple SummaryEndoscopic submucosal dissection (ESD) is accepted as a standard treatment for early gastric cancer (EGC). Non-curative resection (NCR) of EGC after ESD can increase the burden of additional treatment and medical expenses. Thus, we aimed to develop a machine-learning (ML)-based NCR prediction model for EGC prior to ESD. We obtained data from 4927 patients with EGC who underwent ESD between January 2006 and February 2020. Seven ML-based NCR prediction models were developed using ten clinicopathological characteristics. The performance of NCR prediction was highest in the XGBoost model (AUROC, 0.851; 95% confidence interval, 0.837–0.864). Our ML model improved the ability to predict NCR of ESD in patients with EGC. This ML model can provide useful information for decision-making regarding the appropriate treatment of EGC before ESD.Non-curative resection (NCR) of early gastric cancer (EGC) after endoscopic submucosal dissection (ESD) can increase the burden of additional treatment and medical expenses. We aimed to develop a machine-learning (ML)-based NCR prediction model for EGC prior to ESD. We obtained data from 4927 patients with EGC who underwent ESD between January 2006 and February 2020. Ten clinicopathological characteristics were selected using extreme gradient boosting (XGBoost) and were used to develop a ML-based model. Dataset was divided into the training and internal validation sets and verified using an external validation set. Sensitivity, specificity, and area under the receiver operating characteristic curve (AUROC) were evaluated. The performance of each model was compared by using the Delong test. A total of 1100 (22.1%) patients were identified as being treated non-curatively with ESD. Seven ML-based NCR prediction models were developed. The performance of NCR prediction was highest in the XGBoost model (AUROC, 0.851; 95% confidence interval, 0.837–0.864). When we compared the prediction performance by the Delong test, XGBoost (p = 0.02) and support vector machine (p = 0.02) models showed a significantly higher performance among the NCR prediction models. We developed an ML model capable of accurately predicting the NCR of EGC before ESD. This ML model can provide useful information for decision-making regarding the appropriate treatment of EGC before ESD.

Utility of a deep learning model and a clinical model for predicting bleeding after endoscopic submucosal dissection in patients with early gastric cancer.

BACKGROUNDBleeding is one of the major complications after endoscopic submucosal dissection (ESD) in early gastric cancer (EGC) patients. There are limited studies on estimating the bleeding risk after ESD using an artificial intelligence system. AIMTo derivate and verify the performance of the deep learning model and the clinical model for predicting bleeding risk after ESD in EGC patients.METHODSPatients with EGC who underwent ESD between January 2010 and June 2020 at the Samsung Medical Center were enrolled, and post-ESD bleeding (PEB) was investigated retrospectively. We split the entire cohort into a development set (80%) and a validation set (20%). The deep learning and clinical model were built on the development set and tested in the validation set. The performance of the deep learning model and the clinical model were compared using the area under the curve and the stratification of bleeding risk after ESD. RESULTSA total of 5629 patients were included, and PEB occurred in 325 patients. The area under the curve for predicting PEB was 0.71 (95% confidence interval: 0.63-0.78) in the deep learning model and 0.70 (95% confidence interval: 0.62-0.77) in the clinical model, without significant difference (P = 0.730). The patients expected to the low- (< 5%), intermediate- (≥ 5%, < 9%), and high-risk (≥ 9%) categories were observed with actual bleeding rate of 2.2%, 3.9%, and 11.6%, respectively, in the deep learning model; 4.0%, 8.8%, and 18.2%, respectively, in the clinical model. CONCLUSIONA deep learning model can predict and stratify the bleeding risk after ESD in patients with EGC.

Effectiveness of second-look endoscopy after gastric endoscopic submucosal dissection in patients taking antithrombotic agents: a multicenter propensity score matching analysis.

The risk of bleeding after gastric endoscopic submucosal dissection (ESD) in antithrombotic agent users has increased, and its management remains a problem. Second-look endoscopy (SLE) following gastric ESD in antithrombotic agent users may be effective in preventing delayed bleeding, but this requires elucidation. Therefore, this study aimed to investigate the efficacy of SLE in reducing bleeding after gastric ESD in patients receiving antithrombotic agents. This retrospective cohort study was conducted at 19 referral hospitals in Japan. A total of 1,245 patients who were receiving antithrombotic agents underwent gastric ESD between January 2013 and July 2018. The incidence of delayed bleeding was compared between SLE and non-SLE groups using propensity score matching analysis. Overall, 858 patients (SLE group, 657 patients; non-SLE group, 201 patients) were analyzed. After matching, 198 pairs were created. Delayed bleeding occurred in 10 patients (5.1%) in the SLE group and 16 patients (8.1%) in the non-SLE group [odds ratio (OR) 0.605, 95% confidence interval (CI) 0.23-1.46, p = 0.310]. In the subgroup analysis, SLE reduced the incidence of delayed bleeding in patients receiving heparin bridging therapy (6.3% and 40.0%, respectively; p = 0.004). In the SLE group, prophylactic coagulation did not significantly reduce delayed bleeding compared to the no treatment group (14.6% and 8.6%, respectively; p = 0.140). SLE was ineffective in reducing bleeding after gastric ESD in antithrombotic agent users, overall. A prospective comparative study is warranted to definitively evaluate the effectiveness of SLE in reducing bleeding in high-risk patients.

Esophageal Mucosal Autograft for Preventing Stricture After Widespread Endoscopic Submucosal Dissection of Superficial Esophageal Lesions.

Although esophageal mucosal autograft prevents esophageal stricture after widespread endoscopic submucosal dissec- tion and has been reported as a new technique, it is relatively unproven in clinical practice. This prospective study was conducted to evaluate our experience using esophageal mucosal autograft to prevent strictures after widespread endoscopic submucosal dissection in patients with widespread superficial esophageal lesions. Between October 2017 and June 2018, 15 patients with widespread superficial esophageal lesions were consecutively treated with widespread endoscopic submucosal dissection and then underwent esophageal mucosal autograft. The main outcomes measured included esophageal epithelialization and esophageal stricture. The median longitudinal diameter of the widespread superficial esophageal lesions was 5.2 cm. All 15 patients were success- fully treated with widespread endoscopic submucosal dissection and esophageal mucosal autograft, and the median procedural time was 182 minutes. During follow-up (median, 23 months), esophageal epithelialization was found in 13 patients (86.7%), and 7 patients experienced esophageal stricture (46.7%). In those 7 patients, the esophageal strictures were successfully relieved after endoscopic bal- loon dilation or endoscopic radial incision. No complications related to endoscopic balloon dilation/endoscopic radial incision occurred. Additionally, local recurrence was found in 1 patient with poorly differentiated squamous cell carcinoma, and further surgical resection was performed. Esophageal mucosal autograft appears to be an efficient approach to reconstructing local esophageal epithelium and might have a potential role in preventing esophageal stricture after widespread endoscopic submucosal dissection. However, as a new technique, it needs more improvement to enhance its role in preventing esophageal stricture after widespread endoscopic submucosal dissection.

Applicability of endoscopic submucosal dissection for patients with early gastric cancer beyond the expanded indication for endoscopic submucosal dissection.

Endoscopic submucosal dissection (ESD) application for patients with tumors beyond the expanded indication for ESD is inconclusive. This study aimed to identify the preoperative clinical features that can be curatively treated with ESD in patients with early gastric cancer (EGC) beyond the indication of ESD. From 2006 to 2016, 673 patients who underwent gastrectomy for EGC beyond the expanded indication for ESD based on preoperative assessments were retrospectively reviewed. We identified tumors curatively resected by ESD based on the postoperative pathologic findings. We also analyzed the clinical and pre-treatment features to determine the risk factors associated with curative resection of ESD. 39% of the patients (263/673) who had undergone gastrectomy had tumors of endoscopic curability A or B (eCuraA/B) that could be treated by ESD alone. In multivariate analysis, tumor size ≤ 10mm (OR 0.240; 95% CI = 0.12-0.46), no ulceration (OR 0.500; 95% CI = 0.29-0.87), differentiated histology (OR 0.599; 95% CI = 0.43-0.84), and location in the distal two-thirds of the stomach (OR 0.499; 95% CI = 0.28-0.88) in pre-treatment assessment were identified as independent predictors of eCuraA/B. Considering the risk factors, 63.6% (7/11)/61.3% (19/31) of patients with a differentiated/undifferentiated tumor size ≤ 10mm located in distal two-third of the stomach without ulceration were deemed as eCuraA/B. This study suggests that patients with EGC indicated for surgery can be treated by ESD by adding tumor locations in the indication for ESD. Thus, ESD can be applied for patients with a tumor size ≤ 10mm located in the lower/middle stomach without ulceration.

Comparison of the procedure time differences between hybrid endoscopic submucosal dissection and conventional endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for a multi-center randomized controlled trial (Hybrid-G trial)

BackgroundEndoscopic submucosal dissection (ESD) is widely accepted as a local treatment for gastrointestinal tract tumors. As a simplified endoscopic procedure, hybrid ESD (H-ESD) has been performed for colorectal neoplasms in recent times. However, whether H-ESD is superior to conventional ESD (C-ESD) for patients with early gastric neoplasms (EGN) remains unclear. In this trial, we will compare the treatment outcomes of H-ESD and C-ESD. We hypothesize that the procedure time for H-ESD is shorter than that for C-ESD.MethodsThis is an investigator-initiated, multi-center, prospective, randomized, open-label, parallel-group trial to be conducted beginning in August 2020 at nine institutions in Japan. We will determine if H-ESD is superior to C-ESD in terms of procedure time in patients with EGN diagnosed as macroscopically intramucosal (T1a) differentiated carcinoma ≤ 20 mm in diameter without ulcerative findings according to current Japanese gastric cancer treatment guidelines. A total of 82 patients will be recruited and randomly assigned to either the C-ESD or the H-ESD group. The primary outcome is ESD procedure time. Secondary outcomes include mucosal incision, time and speed of submucosal dissection, en bloc resection, complete resection, curability, adverse events related to the ESD procedure, extent of dissection before snaring, volume of injection solution, number and time of hemostasis, thickness of the submucosal layer in the resected specimen, and handover to another operator. The stated sample size was determined based on the primary outcome. According to a previous report comparing the procedure times of C-ESD and H-ESD, we hypothesized that H-ESD would provide a 0.2 reduction in logarithmically concerted procedure time (−37%). We estimated that a total of 82 participants were needed to reach a power of 80% for a t-test with a significance level of 0.05 and considering a 10% dropout.DiscussionThis trial will provide high-quality data on the benefits and risks of H-ESD for EGN patients. The results of this study could lead to improved outcomes in patients with EGN undergoing ESD. The results will be presented at national and international meetings and published in peer-reviewed journals.Trial registrationUMIN-CTR UMIN000041244. Registered on July 29, 2020.