Early Gastric Cancer

Early gastric cancer (EGC) is traditionally treated with either endoscopic resection or standard laparoscopic gastrectomy with formal lymph node dissection. However, endoscopic resection cannot evaluate or treat regional lymph node metastasis, whereas standard surgery significantly impairs postoperative gastric physiological function and patient quality of life (QoL). The LENS trial is a prospective, single-arm clinical study designed to evaluate the feasibility, safety, and long-term efficacy of Laparoscopic and Endoscopic Cooperative Surgery (LECS) combined with Laparoscopic Sentinel Node Navigation Surgery (LSNNS) using Indocyanine Green (ICG) fluorescence tracing for patients with cT1N0M0 early gastric cancer. In this trial, eligible patients will undergo intraoperative sentinel lymph node (SN) biopsy guided by ICG. Patients with negative SN status will receive stomach-preserving surgery (primarily Non-exposed Endoscopic Wall-inversion Surgery, NEWS), while those with positive SN status will convert to standard laparoscopic gastrectomy. The primary goal is to confirm whether this combined procedure provides long-term oncological safety comparable to standard radical gastrectomy, while significantly improving postoperative gastric function, nutritional status, and quality of life.

This prospective, single-center, randomized controlled trial aims to evaluate the clinical effectiveness of an Image-Guided Platform assisted by a deep learning model for sentinel lymph node (SLN) retrieval in patients with early gastric cancer undergoing laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS). A total of 36 eligible participants will be randomly assigned in a 1:1 ratio to either the Image-Guided Platform group or the Traditional Palpation group. Both groups will undergo standardized indocyanine green fluorescence-guided sentinel lymphatic basin dissection and initial retrieval of fluorescent sentinel lymph nodes. In the experimental group, the remaining sentinel lymphatic basin (SLB) tissue will be examined using the Image-Guided Platform, which integrates radiographic and optical imaging with a deep learning model to identify and localize suspected lymph nodes. In the control group, LN retrieval will be performed using traditional visual inspection and palpation. The primary objective is to determine whether Image-Guided Platform-assisted LN retrieval increases the total number of SLNs retrieved intraoperatively compared with Traditional Palpation. Secondary objectives include assessment of LN retrieval efficiency, pathological findings, additional LN identification during permanent pathological examination, concordance between intraoperative frozen-section and permanent pathological examination, and other procedural, pathological, technical, and clinical outcomes relevant to the feasibility and performance of the Image-Guided Platform and deep learning model.

This study is to evaluate the safety and efficacy of dual-endoscope assisted sentinel lymph node navigation surgery for early gastric cancer (EGC).

To estimate the prevalence of histologically confirmed early gastric cancer (EGC) in an Indian multicentre cohort undergoing standardised high-quality upper gastrointestinal endoscopy. EGC is defined as gastric adenocarcinoma confined to the mucosa or submucosa (T1), irrespective of lymph node status, based on histopathology.

The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.

The goal of this retrospective observational cohort study is to describe the real-world clinicopathological characteristics, evolving treatment patterns, and long-term oncological outcomes of early gastric cancer (EGC) patients in China, utilizing a large prospective clinical database. The main questions it aims to answer are: How do different treatment modalities, including endoscopic resection, laparoscopic surgery, open surgery, and combined laparoscopic-endoscopic approaches, influence the long-term survival (Overall Survival and Disease-Free Survival) and recurrence patterns in Chinese EGC patients? What are the key clinicopathological factors affecting prognosis in this population? This study will retrospectively enroll approximately 5000 patients with histopathologically confirmed gastric adenocarcinoma staged as early gastric cancer (per AJCC 8th edition) from the information database of the National Clinical Research Center for Digestive Diseases. Researchers will systematically collect baseline demographics, treatment details, surgical complications, pathological staging, and longitudinal follow-up data (up to 10 years post-surgery) for all eligible patients. By comparing the short-term safety profiles and long-term survival benefits across different treatment groups and identifying risk factors for recurrence, this study aims to provide high-quality, China-specific evidence to guide standardized and individualized clinical decision-making for early gastric cancer.

This multicenter retrospective and prospective real-world observational study will evaluate the relationship of Helicobacter pylori (H. pylori) infection status, intragastric distribution, and pathological features with gastric cancer biological behavior and long-term prognosis in patients with early gastric cancer or related gastric neoplastic lesions undergoing endoscopic submucosal dissection (ESD). H. pylori infection is an important risk factor for gastric cancer. In clinical practice, H. pylori status can be assessed by several methods, including the 13C-urea breath test, serum H. pylori antibody testing, and pathological assessment of gastric tissue. These methods may not always provide the same result because they reflect different aspects of infection, including current active infection, previous exposure, prior eradication status, and local tissue-based detection. The study will include approximately 1500 participants from participating medical centers. About 1000 participants will be retrospectively identified from existing clinical, endoscopic, pathological, H. pylori testing, and follow-up records, and about 500 additional participants will be prospectively enrolled. The study will evaluate H. pylori infection status, prior eradication status, discordant testing patterns, tissue-based and intragastric H. pylori distribution, background mucosal changes, and pathological features of early gastric cancer or related gastric neoplastic lesions. These features will be analyzed in relation to different gastric cancer subtypes and biological behavior. Follow-up information will be used to evaluate whether the integrated analysis of H. pylori infection status and pathological features can predict clinical outcomes at 1, 2, and 3 years after ESD and during long-term follow-up, including local recurrence, metachronous gastric cancer, synchronous or multifocal early gastric cancer detected within 1 year, additional surgical treatment, survival, and other clinically meaningful outcomes.

Early gastric cancer (EGC) is often difficult to detect accurately during endoscopic examination due to subtle morphological features and variability among endoscopists. Artificial intelligence (AI) has shown promise in improving diagnostic performance; however, most existing models lack interpretability and rely on single-modality imaging. This study aims to develop and evaluate an explainable multimodal artificial intelligence model for the diagnosis of early gastric cancer using endoscopic imaging. The model integrates features derived from white-light imaging and image-enhanced endoscopy, along with quantitative image features and clinical data, to improve diagnostic accuracy and provide interpretable decision support. The primary outcome is the diagnostic performance of the AI model for detecting early gastric cancer, evaluated by area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity. The results of this study are expected to provide evidence for the clinical utility of explainable AI in endoscopic diagnosis and support the development of reliable human-AI collaborative diagnostic systems.

The pathological biopsy of gastric lesions, performed prior to endoscopic submucosal dissection (ESD), is crucial for differentiating the pathological nature of the lesions and guiding treatment decisions. However, due to the impact of biopsy sampling, the sensitivity of the pathological biopsy is not optimal. The probe - based confocal laser endomicroscopy (pCLE) technique enables the real - time display of high-resolution microscopic images of the mucosal layer (with an amplification factor of up to 1000 times) through a slender optical fiber probe that can pass through the standard endoscope's working channel. It is an optical biopsy technique and has unique value in determining the pathological nature of gastric lesions. As the Digestive Endoscopy Center of Shanghai Changhai Hospital is a national-level pCLE application demonstration center, it has prospectively collected numerous cases of pCLE examinations of gastric mucosal lesions. The main purpose of this study is to retrospectively analyze these cases and compare the sensitivity and specificity of pathological biopsy and pCLE in differentiating the pathological nature of gastric mucosal lesions.

Endoscopic submucosal dissection (ESD) is an established treatment for early gastric cancer and precancerous lesions. Post-ESD artificial ulcers may lead to complications including delayed bleeding (3-15%) and prolonged healing. Current guidelines recommend high-dose proton pump inhibitors (PPIs), but evidence for additional mucosal protective agents remains limited. This study aims to evaluate whether combining sucralfate suspension with standard intravenous esomeprazole therapy improves ulcer healing and reduces complications after gastric ESD compared to esomeprazole alone. This is a prospective, randomized, controlled, outcome-assessor-blinded trial. A total of 120 patients undergoing gastric ESD will be randomly assigned 1:1 to receive either: * Intervention group: Intravenous esomeprazole 40mg twice daily (3 days) followed by oral esomeprazole 40mg once daily PLUS sucralfate suspension 1g twice daily for 8 weeks * Control group: Intravenous esomeprazole 40mg twice daily (3 days) followed by oral esomeprazole 40mg once daily for 8 weeks The primary outcome is ulcer reduction rate at 4 weeks post-ESD, assessed by endoscopy. Secondary outcomes include complete ulcer healing rate at 8 weeks, delayed bleeding rate, symptom scores, and safety parameters. This study will provide high-quality evidence regarding the role of sucralfate as an adjunctive therapy for post-ESD ulcer management and may inform future clinical guidelines.

This is a multicenter randomized controlled clinical trial designed to evaluate the clinical efficacy and cost-effectiveness of a digital health platform that integrates a symptom reporting and management software with a standardized telenursing program, allowing cancer patients to actively monitor, report, and self-manage chemotherapy-related adverse effects.

For patients with non-curative resection after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC), complementary surgery is generally recommended. However, about 2/3 of patients have no remaining tumor in the stomach or regional lymph nodes. In this trial, Indocyanine Green (ICG)-guided lymphadenectomy with or without laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive alternative in such cases. For patients with a primary radically resected EGC, ICG-guided lymphadenectomy alone will be performed. For patients with deep-margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed, in order to ensure both local tumor control in the stomach and in regional nodes.

This study aimed to analyze the distribution characteristics of Helicobacter pylori（H. pylori） in varying stages of atrophic gastritis and early gastric cancer using immunohistochemical staining, with the goal of providing guidance for the early screening of gastric cancer. A retrospective analysis was conducted on gastric biopsy cases that underwent H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025. Cases were classified into non-atrophic and atrophic groups based on the presence or absence of gastric atrophy. All cases were further divided into non-open and open atrophy groups and additionally into early gastric cancer and non-cancer groups. The distribution of H. pylori across subgroups was compared, and multivariate analyses were performed to identify risk factors associated with the development of early gastric cancer.

Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.The investigators will conduct a study to develop and validate a diagnostic model based on NBI for early gastric cancerous lesions under endoscopic observation.

Because advanced gastric cancer shows poor prognosis, it is important to detect early gastric cancer or precancerous gastric adenoma patients who have a cure rate of 95% or more. Moreover, a large part of early gastric cancer can be completely resected by endoscopic resection, thus ensuring a very high quality of life for patients. However, there are currently no markers that can be used for diagnosis of early gastric cancer or gastric adenoma. In addition, the biggest problem after endoscopic resection of early gastric cancer is metachronous recurrence of the cancer, which requires repeated endoscopic resection or additional surgical gastrectomy. However, there are no discovered markers for prediction of recurrence. Liquid biopsy is a method of obtaining body fluids such as gastric juice or effusion through an endoscopic inlet during gastroscopy or colonoscopy and blood. Based on the advanced analysis method, liquid biopsy reveals more genetic information than tissue biopsy. Therefore, it is highly likely to become an essential factor in future personalized medicine. Therefore, this study was designed to identify whether tumor's molercular profiling based on tissue or blood could be used for prediction of prognosis and diagnosis of early gastric cancer and precancerous gastric adenoma.

Endoscopic submucosal dissection (ESD) is a technique that allows curative treatment of early gastrointestinal neoplasia with organ preservation. However, it is a technically demanding procedure. Tissue traction plays a vital role in facilitating the visualization of the cutting line and the submucosal vessels, which usually only relies on the hood attached to the tip of the endoscope. However, when dealing with flat or large lesions, the absence of reliable traction in ESD contributes to its technical complexity and prolongs procedure duration. Various traction devices and techniques have been developed to provide tension for the dissection plane and optimal visibility during ESD. Most of these only provide static traction from a fixed angle, thus the effect of traction diminishes when the dissection continues. In contrast to the aforementioned traction methods, magnetic traction offers the ability to externally manipulate an internal magnetic retractor, simplifying the internal workspace. The proposed magnetic retractor is composed of a detachable clip from an hemoclip is affixed to a magnetic element. By adjusting the position of the external magnetic source, the magnetic retractor automatically couples and aligns with it, enabling simultaneous dynamic directional control during the ongoing ESD operation. A novel robotic magnetic countertraction system was developed (MAG-ESD). The system consists of two sections: an external permanent magnetic source and the disposable magnetic retractor. The external permanent magnetic source is composed by a large external permanent magnet (EPM) which held by robot arm to externally control the locomotion of the magnetic retractor within patient. The disposable magnetic retractor is a consumable surgical instrument that modified from a commercial hemoclip, which has small magnets hangs on the clip legs. The design of the disposable magnetic retractor eliminates the need for endoscope withdrawal which can be inserted through the instrument channel from the handle during ESD operations, like other common instruments. In the current pilot study, the novel MAG-ESD counetrtraction system would be tested in 20 patients who undergo gastric and colonic ESD, with the aim of evaluating the system efficacy and safety.

The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are: Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system. Participants will: Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system. Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.

This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research.

SENORITA 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer can increase the quality of life. (Ryu KW et al. JCO 2022) The radioactive isotope is difficult to use because of the hazard of radiation and shortage of materials. The aim of this study is to investigate whether laparoscopic sentinel lymph node biopsy and stomach-preserving surgery using only fluorescence is feasible.

This study is a single-center, prospective, group-controlled clinical trial, aiming to clarify the relationship between the depth of dissection and scar formation in the treatment of early gastric cancer by ESD, and to provide high-quality evidence-based medicine for the treatment of early gastric cancer.

This study collect the relevant data of local residents over 20 years old in 11 regions of Shaanxi Province, The basic information of the subjects was collected by filling in the questionnaire, and serum helicobacter pylori antibody detection was completed at the same time. The expert group determined the high-risk population of gastric cancer after comprehensive evaluation. All the high-risk population of gastric cancer without contraindications underwent electronic gastroscopy in the designated hospital after signing the informed consent. By collecting and analyzing data, early gastric cancer screening was completed and a new gastric cancer risk assessment model was established to evaluate the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as helicobacter pylori infection, radical treatment and recurrence rate.

This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.

In this study, patients who are going to undergo endoscopic submucosal dissection (ESD) or surgery for early gastric cancer will be enrolled and divided into ESD group and Surgery group according to the procedure they go through. The patients will be followed up for at least 5 years after ESD or surgery. Esophagogastroduodenoscopy (EDG) and biopsy will be performed 3 months and then 6 months after ESD or surgery. Thereafter, EDG will be performed along with biopsy and abdominal computed tomography annually up to 5 years. Patients' data such as age, sex, clinical diagnosis, achievement of en-bloc resection, pathological outcomes, complications and survival condition will be prospectively collected. Statistical methods such as Student's t-test, the chi-square test, the Kaplan-Meier method and the log-rank test will be used to compare the short term and long term outcomes between the ESD group and the surgery group.