Dissection For Early Gastric Cancer Research Articles

Clinical significance of additional gastrectomy after non-curative endoscopic submucosal dissection for early gastric cancer: a retrospective single-center study.

Additional surgery is recommended for patients after a non-curative endoscopic submucosal dissection (ESD) to prevent residual cancer (RC) or lymph node metastasis (LNM). We aimed to evaluate the clinicopathologic characteristics of patients who underwent an additional gastrectomy after a non-curative ESD procedure and identify the risk factors of RC and LNM. We retrospectively assessed the clinicopathological factors of 73 patients who underwent additional gastrectomy following a non-curative ESD between January 2009 and December 2019 at our center. RC and LNM rates after additional gastrectomy were 9.6% and 8.2%, respectively. Invasion deeper than 500 μm (P=0.045), positive horizontal resection margin (P<0.001), and positive ESD margin (P=0.001) were identified as statistically significant factors in univariate analysis for RC, but not in multivariate analysis. Lymphatic invasion was the only risk factor found to be significant in both univariate and multivariate analyses (P=0.005 and P=0.012). Additional gastrectomy is necessary to prevent RC or LNM after non-curative ESD. Lymphatic invasion was also associated with LNM in patients who underwent an additional gastrectomy after a non-curative ESD, and in such cases, active treatment is required.

Influence of hospital volume on bleeding after endoscopic submucosal dissection for early gastric cancer in Japan: a multicenter propensity score-matched analysis.

Information on whether there is a relationship between hospital volume and bleeding after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is limited. This study aimed to compare the bleeding rates after ESD for EGC according to the hospital volume. Patients who underwent ESD for EGC at 33 institutions in Japan between November 2013 and October 2016 were included in this multicenter retrospective study. Hospital volume was categorized into three groups, based on the average annual number of ESD procedures: low- and medium-volume group (LMVG), high-volume group (HVG), and very high-volume group (VHVG). The bleeding rate after ESD for EGC was compared between the three hospital volume groups after propensity score matching. A total of 10,320 patients, including 2797 patients in the LMVG, 4646 patients in the HVG, and 2877 patients in the VHVG, were identified. Propensity score matching yielded 2002 patients in each hospital volume group, with an improved balance of confounding variables between the three groups. The bleeding rates in the LMVG, HVG, and VHVG were 4.3%, 3.7%, and 4.9%, respectively, and no significant difference was noted between the three groups. The bleeding rate after ESD for EGC did not differ between hospitals in Japan. The finding indicated that ESD for EGC is equally feasible across Japanese hospitals of different volumes regarding bleeding after ESD.

Clinical Effectiveness of Digestive Endoscopic Mucosal Dissection for Early Gastric Cancer

Clinical Effectiveness of Digestive Endoscopic Mucosal Dissection for Early Gastric Cancer

Long-term Outcomes of Additional Endoscopic Treatments for Patients with Positive Lateral Margins after Endoscopic Submucosal Dissection for Early Gastric Cancer.

Background/AimsIt is uncertain whether additional endoscopic treatment may be chosen over surgery in patients with positive lateral margins (pLMs) as the only non-curative factor after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). We aimed to compare the long-term outcomes of additional endoscopic treatments in such patients with those of surgery and elucidate the clinicopathological factors that could influence the treatment selection.MethodsA total of 99 patients with 101 EGC lesions undergoing additional treatment after non-curative ESD with pLMs as the only non-curative factor were analyzed. Among them, 25 (27 lesions) underwent ESD, 29 (29 lesions) underwent argon plasma coagulation (APC), and 45 (45 lesions) underwent surgery. Clinicopathological characteristics and long-term outcomes were compared.ResultsResidual tumor was found in 73.6% of cases. The presence of multiple pLMs was associated with higher risk of residual tumor (p=0.046). During a median follow-up of 58.9 months, recurrent or residual lesions after additional ESD and APC were found in 4% (1/25) and 6.8% (2/29) of patients, respectively. However, all were completely cured with surgery or repeated ESD. There were no extragastric recurrences after additional endoscopic treatment. Lymph node metastasis was identified after additional surgery in one (2.2%) patient with an EGC showing histological heterogeneity.ConclusionsGiven the favorable long-term outcomes, additional ESD or APC may be an acceptable choice for patients with pLMs as the only non-curative factor after ESD for EGC. However, clincopathological characteristics such as multiple pLMs and histological heterogeneity should be considered in the treatment selection.

An effective method for removing surgical staples during endoscopic submucosal dissection for early gastric cancer on the suture line of remnant stomach.

Video 1The video shows the method for removing surgical staples during endoscopic submucosal dissection for early gastric cancer on the suture line of remnant stomach. The staples were removed one by one using the knife in EndoCut mode while pulling out the staple.

Impact of Comorbidities, Sarcopenia, and Nutritional Status on the Long-Term Outcomes after Endoscopic Submucosal Dissection for Early Gastric Cancer in Elderly Patients Aged ≥ 80 Years.

Simple SummaryThe average human life expectancy is increasing worldwide, which is leading to increases in the proportion of elderly patients (≥80 years) with gastric cancer. Endoscopic submucosal dissection (ESD) is widely regarded as a safe and effective treatment for early gastric cancer (EGC), even in aged or high-risk patients. We investigated the oncologic outcomes in elderly patients who underwent endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) by focusing on the impact of comorbidities, sarcopenia, and nutritional status. Over a median follow-up period of 70.5 months, the 3- and 5-year overall survival (OS) rates were 89.5% and 77.1%, respectively; of the114 patients who died, only four (3.5%) were due to gastric cancer. A total of 173 (61.8%) had sarcopenia, and they had lower rates of 3-year (88.4% vs. 91.4%) and 5-year (73.1% vs. 84.0%; p = 0.046) OS than did those without sarcopenia. In multivariable analyses, prognostic nutritional index (hazard ratio [HR], 0.93; 95% confidence interval [CI]: 0.90–0.98; p = 0.002) and Charlson comorbidity index (HR 1.19; 95% CI: 1.03–1.37; p = 0.018) showed that ESD was a feasible and safe therapeutic method to use in elderly patients, whose long-term survival was significantly associated with nutritional status and comorbidities.Background/Aim: We investigated the oncologic outcomes in elderly patients who underwent endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) by focusing on the impact of comorbidities, sarcopenia, and nutritional status. Methods: Between 2005 and 2016, 280 patients aged ≥ 80 years with 289 EGCs underwent ESD at a tertiary care center. The short- and long-term survival outcomes were assessed. Cox regression analysis was used to identify factors associated with survival, including clinicopathologic factors and abdominal muscle area measured by computed tomography. Results: The rates of en bloc, R0, and, curative resection were 99.3%, 90.0%, and 69.2%, respectively. The rates of post-ESD bleeding and perforation rates were 2.1% and 3.1%, respectively, and no cases showed significant life-threatening adverse events. Over a median follow-up period of 70.5 months, the 3- and 5-year overall survival (OS) rates were 89.5% and 77.1%, respectively; of the114 patients who died, only four (3.5%) were due to gastric cancer. A total of 173 (61.8%) had sarcopenia, and they had lower rates of 3-year (88.4% vs. 91.4%) and 5-year (73.1% vs. 84.0%; p = 0.046) OS than did those without sarcopenia. In multivariable analyses, prognostic nutritional index (hazard ratio [HR], 0.93; 95% confidence interval [CI]: 0.90–0.98; p = 0.002) and Charlson comorbidity index (HR 1.19; 95% CI: 1.03–1.37; p = 0.018) were significant factors associated with overall survival. Conclusions: ESD was a feasible and safe therapeutic method to use in elderly patients, whose long-term survival was significantly associated with nutritional status and comorbidities. These results suggest the need for a possible extension of the curative criteria for ESD in elderly patients with EGC.

Pilot Study of Acupuncture's Antispasmodic Effect on Upper Gastrointestinal Tract during Endoscopic Submucosal Dissection for Early Gastric Cancer: Controlled Clinical Trial.

A prospective study was conducted in patients with early-stage gastric cancer to determine the efficacy and safety of acupuncture stimulation as an antispasmodic compared with conventional medication during the procedure of endoscopic submucosal dissection (ESD) of the upper gastrointestinal tract. This study was a prospective single blinded quasi-randomized controlled trial. Seventy-three patients who were scheduled to undergo ESD for gastric cancer at Aizu Medical Center between 19 February 2016 and 30 June 2016 were assessed for eligibility for the study. Sixty out of 73 patients were included in the study and assigned into two intervention groups: medication group (MG) and acupuncture group (AG). Ease of the procedure was evaluated using modified NIWA classification (MNC) by endoscopist considering the frequency and amplitude of the upper gastrointestinal peristalsis. For the statistical analysis, Mann–Whitney test was used to compare the differences of MNC values (baseline and end of procedure) between two groups. The difference of MNC found in the AG (−2.00 (−3.0 to −2.0)) was significantly greater than that in the MG (−1.00 (−2.0 to −1.0), p < 0.0001, Mann–Whitney test). We consider that acupuncture to the abdomen could be an alternative antispasmodic method during upper gastrointestinal endoscopic procedure.

P-247 In vivo feasibility study of a robotic arm-assisted endoscopic submucosal dissection for early gastric cancer

Appropriate tissue tension and clear visibility of the dissection area using traction are essential for effective and safe endoscopic submucosal dissection (ESD). We developed a robotic assistive traction device for flexible endoscopy and compared its safety and efficiency in ESD between experienced and novice endoscopists. Robotic ESD was performed by experienced and novice endoscopist groups (n = 3, each). The outcomes included time to complete each ESD step, total procedure time, size of the dissected mucosa, rate of en bloc resection, and major adverse events. Furthermore, the incision and dissection speeds were compared between the groups. Twenty gastric lesions were resected from ten live pigs. In the experienced group, the mean incision speed was faster significantly. There was no significant difference in the submucosal dissection speed between the groups. No complications were reported in either group. In conclusion, ROSE can provide simple, effective, and safe multidirectional traction and countertraction during ESD. While performing robotic ESD, experienced endoscopists expressed satisfaction, and novices could perform ESD safely and efficiently. We expect our device to help trainees perform ESD in places where ESD education is difficult to obtain. The device must be made smaller, and its safety and efficacy in humans should be assessed in future studies.

Current indications for endoscopic submucosal dissection of early gastric cancer.

The development of endoscopic treatment technology has further promoted the minimally invasive treatment of early gastric cancer (EGC). Endoscopic treatment has achieved better therapeutic effects in terms of safety and prognosis and is the preferred treatment method for patients who meet the indications for endoscopic treatment. However, the consequent problem is that some patients receiving endoscopic treatment may undergo non-curative resection, and the principle of follow-up management for non-curative resection patients deserves further attention. In addition, there are still debates on how to improve the accuracy of clinical staging, select a reasonable treatment method for patients who meet the expanded indications for endoscopic treatment, manage patients with positive endoscopic surgical margins, conduct research on function-preserving surgery, and manage the treatment of EGC under the current situation in China. Consequently, we aim to review current indications for endoscopic submucosal dissection of EGC in order to better inform treatment options.

How to Perform a High-Quality Endoscopic Submucosal Dissection

How to Perform a High-Quality Endoscopic Submucosal Dissection

Recurrence rate of intramucosal gastric cancer with positive vertical margin due to lesion damage during endoscopic submucosal dissection.

In principle, additional surgery is performed after endoscopic submucosal dissection for early gastric cancer if the vertical margin is positive, regardless of lesion damage. The recurrence rate of vertical margin-positive lesions due to lesion damage after endoscopic submucosal dissection is unknown, and unnecessary surgeries may be performed. In this study, we investigated whether there was a difference in the recurrence rate between vertical margin-positive lesions due to lesion damage and vertical margin-negative lesions. We included 1,294 intramucosal gastric cancer lesions that were resected by endoscopic submucosal dissection between January 2008 and December 2016, without additional surgery. The lesions were divided into the Damage and No damage groups based on vertical margin status. The Damage group had only one non-curative indication: a positive vertical margin due to lesion damage. The No damage group had no non curative indications. We compared the recurrence rate between the Damage and No damage groups. The recurrence rates of the Damage and No damage groups were 0% (0/23; 95% confidence interval: 0-14.8%) and 0% (0/1,271; 95% confidence interval: 0-0.003%), respectively, with no statistically significant difference. In intramucosal gastric cancer, the recurrence rate of vertical margin-positive lesions due to lesion damage was 0%, which did not differ from that of vertical margin-negative lesions with curative resection. Follow-up, instead of additional surgery, may be an option for patients with non-curative resection when the only non-curative indication is a positive vertical margin due to lesion damage.

Increased Reflux Esophagitis after Helicobacter pylori Eradication Therapy in Cases Undergoing Endoscopic Submucosal Dissection for Early Gastric Cancer

Simple SummaryHelicobacter pylori infection is associated with the development of gastric cancer. Reflux esophagitis may occur in the postoperative period of patients undergoing surgical therapy for gastric cancer. The role of eradication therapy of Helicobacter pylori in reflux esophagitis is controversial. Here, we evaluated the occurrence of reflux esophagitis before and after Helicobacter pylori eradication in patients having endoscopic submucosal resection for early gastric cancer. Reflux esophagitis before and after eradication therapy was evaluated during the follow-up. While reflux esophagitis incidence increased from 3.1% to 18.8% in the successful eradication group, no case of reflux esophagitis was observed in the failed eradication group. There was a significant correlation between successful Helicobacter pylori eradication rate and reflux esophagitis development. This study demonstrates that a successful Helicobacter pylori eradication therapy is a risk factor for newly developed reflux esophagitis in patients having endoscopic submucosal dissection for early gastric cancer.Background: The role of Helicobacter pylori in the pathogenesis of reflux esophagitis is controversial. This study investigated the frequency of reflux esophagitis before and after H. pylori eradication in patients having endoscopic submucosal dissection for early gastric cancer. Methods: This study included 160 patients that fulfilled the study’s criteria. Endoscopy was performed before and after H. pylori eradication, and reflux esophagitis was evaluated during the follow-up period. Results: Seropositivity for H. pylori in patients with early gastric cancer was 68.8%, 101 of them received eradication therapy. During the follow-up period, the incidence of reflux esophagitis increased from 3.1% to 18.8% in the successful eradication group but no case of reflux esophagitis was observed in the failed eradication group. The univariate and multivariate analyses showed a significant correlation between successful H. pylori eradication rate and the development of reflux esophagitis. Conclusions: This study demonstrated that a successful H. pylori eradication therapy is a risk factor for newly developed reflux esophagitis in patients with endoscopic submucosal dissection for early gastric cancer.

Rebleeding in patients with delayed bleeding after endoscopic submucosal dissection for early gastric cancer.

Delayed bleeding is a major adverse event in endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Some patients may experience rebleeding after successful hemostasis for delayed bleeding, yet the details of rebleeding remain unclear. We aimed to clarify the frequency and risk factors of rebleeding. Among 11,452 patients who underwent ESD for EGC at 33 institutions in Japan between 2013 and 2016, we analyzed 489 patients showing delayed bleeding. The rate of rebleeding was investigated. Subsequently, 15 candidate variables were evaluated for their influence on the risk of rebleeding via logistic regression analysis. Rebleeding occurred in 11.2% (55/489) of the enrolled patients. Multivariate analysis revealed that warfarin [odds ratio (OR), 2.71; 95% confidence interval (CI), 1.26-5.84] and a resection size >40mm (OR, 1.99; 95% CI, 1.08-3.67) were independent risk factors for rebleeding. In the analysis of the management of warfarin after index bleeding, only warfarin discontinuation (OR, 3.66; 95% CI, 1.37-9.78) was significantly associated with rebleeding in comparison with no use of warfarin. However, many rebleeding events (75.0%) occurred following the resumption of warfarin. The rebleeding rate during discontinuation status and that in taking warfarin (continuation or resumption) were 6.1% and 20.0%, respectively. Rebleeding was not a rare event in patients experiencing delayed bleeding after ESD for EGC. In addition to having a resection size >40mm, warfarin usage placed patients at high risk for rebleeding, especially at the timing of its resumption following discontinuation as well as its continuation.

First successful case of percutaneous transabdominal thoracic duct embolization (PTTDE) for chylous ascites resulting from laparoscopic gastric cancer surgery

A 61-year-old woman underwent laparoscopy-assisted distal gastrectomy (LADG) with extragastric lymph node dissection (D2). Two months later, she was readmitted to hospital to be treated for chylous ascites. Oral intake was discontinued and total parenteral nutrition started, but increasing body weight and decreasing serum albumin concentration was not controllable. Percutaneous transabdominal thoracic duct embolization (PTTDE) was performed on the 8th day after the readmission. Five days after PTTDE, oral intake was resumed. Seventeen days after PTTDE, the patient was discharged without recurrence of ascites. She has remained asymptomatic. We describe here the first patient with chylous ascites two months after LADG with D2 dissection for early gastric cancer who was successfully treated by PTTDE.

Clinical Outcomes of Endoscopic Submucosal Dissection for Early Gastric Cancer in Patients with Comorbidities

PurposeAs the rate of endoscopic resection for early gastric cancer (EGC) has increased in patients with comorbid diseases, it is necessary to elucidate the efficacy of endoscopic submucosal dissection (ESD) for EGC in patients with comorbidities. This study aimed to analyze the clinical outcomes of ESD for EGC in patients with comorbidities.Materials and MethodsA total of 969 patients with 1,015 lesions who underwent ESD for EGC at Seoul National University Hospital between 2010 and 2014 were analyzed. The short- and long-term clinical outcomes were evaluated according to the comorbidity status.ResultsComorbidities were observed in 558 patients (57.6%). The comorbidity group had a higher proportion of patients using antithrombotic agents (29.5% vs. 0.9%; P<0.0001). Although procedure-related complications (bleeding and perforation) were not significantly different between the two groups, the length of hospital stay was significantly longer (1.8 vs. 1.4 days, P=0.023), while survival was significantly shorter in the comorbidity group (5-year overall survival rate: 90.5% vs. 97.2%, P<0.0001; 5-year disease-specific survival rate: 97.9% vs. 100%, P=0.018; 5-year disease-free survival rate: 83.4% vs. 89.2%, P=0.007).ConclusionsGastric ESD can be performed in patients with comorbidities without increasing the risk of complications.

Long-term persistence of gastric dysbiosis after eradication of Helicobacter pylori in patients who underwent endoscopic submucosal dissection for early gastric cancer

BackgroundGastric microbiome, other than Helicobacter pylori, plays a role in the tumorigenesis of gastric cancer (GC). Patients who undergo endoscopic submucosal dissection for early GC have a high risk of developing metachronous GC even after successful eradication of H. pylori. Thus, we investigated the microbial profiles and associated changes in such patients after the eradication of H. pylori.MethodsA total of 19 H. pylori-infected patients with early GC who were or to be treated by endoscopic resection, with paired biopsy samples at pre- and post-eradication therapy, were retrospectively enrolled. Ten H. pylori-negative patients were enrolled as controls. Biopsy samples were analyzed using 16S rRNA sequencing.ResultsH. pylori-positive patients exhibited low richness and evenness of bacteria with the deletion of several genera, including Blautia, Ralstonia, Faecalibacterium, Methylobacterium, and Megamonas. H. pylori eradication partially restored microbial diversity, as assessed during a median follow-up at 13 months after eradication therapy. However, post-eradication patients had less diversity than that in the controls and possessed a lower abundance of the five genera mentioned above. The eradication of H. pylori also altered the bacterial composition, but not to the same extent as that in controls. The microbial communities could be clustered into three separate groups: H. pylori-negative, pre-eradication, and post-eradication.ConclusionChanges in dysbiosis may persist long after the eradication of H. pylori in patients with a history of GC. Dysbiosis may be involved in the development of both primary and metachronous GC after the eradication of H. pylori in such patients.

Long-Term Outcomes and Prognostic Factors of Endoscopic Submucosal Dissection for Early Gastric Cancer in Patients Aged ≥75 Years.

Simple SummaryThe number of elderly patients with early gastric cancer (EGC) who meet the indications for endoscopic submucosal dissection (ESD) is increasing. Since elderly patients have more comorbidities, and lower life expectancy than younger patients, special considerations to establish treatment strategies according to prognosis is needed. We investigate overall survival and risk factors related to survival after ESD in these patients. During the follow-up, the 3-, 5-, and 10-year overall survival was 91.2%, 83.5%, and 54.5%, respectively. Smoking, history of cancer of other organs, neutrophil to lymphocyte ratio > 1.6, Charlson comorbidity index ≥ 3, and presence of lymphovascular invasion were independent five risk factors for poor overall survival. The long-term outcome of ESD was poorer in elderly patients with risk factors than in those without. These prognostic factors can also be useful in deciding whether to recommend additive surgery and a close follow-up after non-curative endoscopic treatment in the elderly patients.Background and Aims: The number of elderly patients with early gastric cancer (EGC) who meet the indications for endoscopic submucosal dissection (ESD) is increasing. We aimed to evaluate the clinical outcomes and prognostic factors of overall survival (OS) in elderly patients undergoing ESD for EGC. Methods: Between January 2006 and December 2018, 439 patients aged ≥75 years who underwent ESD for EGC were analyzed. The clinical outcomes and prognosis were evaluated, and independent risk factors for OS were identified. Results: The mean patient (302 men, 137 women) age was 78.3 (range 75–92) years. En bloc, R0, and curative resections were achieved in 96.8%, 90.7%, and 75.6%, respectively, without severe adverse events. During the follow-up (median 54.2 (range 4.0–159.6) months), 86 patients died (three of gastric cancer). The 3-, 5-, and 10-year OS was 91.2%, 83.5%, and 54.5%, respectively, and the 3-, 5-, and 10-year cancer related survival rate were 99.7%, 99.1% and 97.5%, respectively. In multivariate analysis, smoking, history of cancer of other organs, NLR > 1.6, Charlson comorbidity index ≥ 3, and presence of lymphovascular invasion (hazard ratio = 3.96, 1.78, 1.83, 1.83, and 2.63, respectively, all p < 0.05) were independent five risk factors for poor OS. The high-risk group (≥3 risk factors) showed a significantly lower OS than the low-risk group (<2 risk factors) (p < 0.001). Conclusions: The five factors could be useful in predicting the long-term prognosis of elderly ESD patients or deciding the therapeutic approaches in case of non-curative resection.

Predictive Factors for Short-Term Survival after Non-Curative Endoscopic Submucosal Dissection for Early Gastric Cancer

Background/Aims: For early gastric cancer (EGC) treated using endoscopic submucosal dissection (ESD) with poor curability defined by the Japanese Guidelines (non-curative EGC, N-EGC), additional gastrectomy has been recommended. However, N-EGC patients without additional gastrectomy often die of other diseases within a relatively short interval after ESD. It has been unclear whether additional gastrectomy is beneficial or not for such patients. The aim of this study was to clarify predictors for short-term survival of N-EGC patients without additional gastrectomy after ESD. Methods: One hundred six N-EGC patients without additional gastrectomy were included in this study. Factors related to short-term survival, defined as death within 3 years after ESD, were evaluated using uni- and multivariate analyses by comparing patients with and without short-term survival (Groups S and C, respectively). Results: During the mean follow-up period of 89 months, 39 patients died (14 patients died within 3 years, being Group S). The cause of death was gastric cancer for only 1 patient in the Group C. The 3- and 5-year overall survival rates were 86.8 and 81.8%, respectively, and the 3- and 5-years disease-specific survival rates were 100 and 98.9%, respectively. Univariate analyses showed that short-term survival was statistically associated with elevated morphology, high-risk status for lymph node metastases as defined by the eCura system, severe comorbidity (Charlson Comorbidity Index [CCI] ≥3), low level of activity in daily living (being unable to go out by oneself), habitation (a nursing home), and several poor nutritional prognostic indices (neutrophil to lymphocyte ratio ≥2.5, geriatric nutritional risk index <92, C-reactive protein ≥1.0). In the multivariate analysis, a high CCI (≥3) was the independent predictor for short-term survival after ESD (odds ratio, 8.1; 95% confidence interval, 1.53–43.0; p = 0.014). Conclusions: Severe comorbidity indicated by a high CCI score (≥3) was the independent predictor for short-term survival for EGC patients without additional gastrectomy after non-curative ESD. Since the cause of death for most patients was not gastric cancer, observational follow-ups without additional gastrectomy might be a reasonable option for patients with a poor general status indicated by a CCI ≥3.

Уникальные цитопротективные свойства ребамипида: обзор фундаментальных и клинических исследований

The article presents current experimental and clinical data on the effectiveness and safety of the use of the drug Rebamipide in the therapy of erosive and ulcerative lesions of the gastrointestinal tract (GIT), including those caused by Helicobacter pylori infection, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, endoscopic submucosal dissection for early gastric cancer For a long time, proton pump inhibitors (PPIs) were the only means of drug prevention of these complications. However, PPIs are effective only for the prevention and treatment of pathology of the upper gastrointestinal tract, but not for pathology of the small intestine. With NSAIDs, gastro- and enteropathies, it is advisable to use drugs that can increase the production of prostaglandins and mucus, restore the permeability of the intestinal epithelium, and have anti-inflammatory and antioxidant effects. Today, doctors have a new instrument for protecting the gastrointestinal mucosa - Rebamipide. This drug is a unique cytoprotector that stimulates the production of endogenous prostaglandins and mucus glycoproteins, inhibits reactive oxygen species, the production of inflammatory cytokines and chemokines, and inhibits the activation of neutrophils. In addition, Rebamipide stimulates the synthesis of epidermal growth factor, vascular endothelial growth factor, and nitric oxide. These properties make it possible to use it in various fields of medicine: gastroenterology, ophthalmology, chemotherapy, rheumatology, and endoscopy. Currently, active developments are underway to create new dosage forms of the drug and search for new therapeutic targets. The aim of this study was to analyze the available publications on clinical and experimental studies of the efficacy and safety of using Rebamipide in the treatment of a wide range of pathological conditions.

Protocol for expanded indications of endoscopic submucosal dissection for early gastric cancer in China: a multicenter, ambispective, observational, open-cohort study

BackgroundThe main treatment methods for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications for ESD remains unestablished. In China, evidence-based medicine for the expanding indications of ESD and accurate diagnostic staging for EGC patients are lacking. Thus, clinical studies involving Chinese patients with EGC are necessary to select appropriate treatment options and promote China’s expanded indications for ESD and diagnostic staging scheme.MethodsThis is a multicenter, ambispective, observational, open-cohort study that is expected to enroll 554 patients with EGC. The study was launched in May 2018 and is scheduled to end in March 2022. All enrolled patients should meet the inclusion criteria. Case report forms and electronic data capture systems are used to obtain clinical data, which includes demographic information, results of perioperative blood- and auxiliary examinations, surgical information, results of postoperative pathology, and the outcomes of postoperative recovery and follow-up. Patients are followed up every 6 months after surgery for a minimum of 5 years. The primary endpoint is the rate of lymph node metastasis (LNM), whereas the secondary endpoints include the following: consistency, sensitivity, and specificity of the results of preoperative examinations and postoperative pathology; cut-off values for LNM; logistic regression model of expanded indications for ESD; and incidence of postoperative complications within the 30-day and 5-year relapse-free survival rates.DiscussionThis study will explore and evaluate expanded indications for ESD that match the characteristics of the Chinese population in patients with EGC and will introduce a related staging procedure and examination scheme that is appropriate for China. Ethical approval was obtained from all participating centers. The findings are expected to be disseminated through publications or presentations and will facilitate clinical decision-making in EGC.Trial registrationThe name of the registry is ChiCTR. It was registered on May 9, 2018, with the registration number (ChiCTR1800016084). The clinical trial was launched in May 2018 and will end in March 2022, with enrollment to be completed by December 2021. Trial status: Ongoing.