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RECRUITING

NCT07835087

Image-Guided Platform-Assisted Sentinel Lymph Node Retrieval in Early Gastric Cancer

Sponsor: Beijing Friendship Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Image-Guided Platform-Assisted Intraoperative and Postoperative Sentinel Lymph Node Retrieval in Early Gastric Cancer: A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-14

Completion Date

2027-08-14

Last Updated

2026-09-22

Healthy Volunteers

Conditions

Early Gastric Cancer Gastric Adenocarcinoma

Interventions

DEVICE

Image-Guided Retrieval Specimen Platform

The Image-Guided Retrieval Specimen Platform is an ex vivo LN retrieval system integrating radiographic imaging, optical imaging, and deep learning-based image analysis. Resected SLB tissue is placed on the platform for image acquisition. The acquired images are analyzed using a deep learning model to identify and localize regions suspected of containing LNs. Physicians subsequently retrieve suspected LNs according to the image-guided and model-generated localization results. All retrieved specimens are submitted for standardized pathological examination.

PROCEDURE

Traditional Palpation-Based Sentinel Lymph Node Retrieval

The residual SLB tissue will be systematically examined by experienced physicians using standardized dissection, visual inspection, and manual palpation to identify and retrieve suspected LNs. No Image-Guided Platform or deep learning-assisted localization will be used.

Inclusion Criteria: 1. Age between 18 and 80 years, inclusive. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and considered able to tolerate surgery and anesthesia. 3. Histologically confirmed gastric adenocarcinoma based on preoperative endoscopic biopsy. 4. Clinical stage cT1N0M0 based on multidisciplinary evaluation and appropriate preoperative examinations, including endoscopy and imaging, or patients after non-curative endoscopic submucosal dissection (ESD) who are considered appropriate candidates for further surgical treatment. 5. Adequate hepatic, renal, cardiac, pulmonary, and bone marrow function to tolerate the planned surgical and perioperative management. 6. Considered clinically suitable for laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS). 7. Able to understand the study procedures and provide written informed consent voluntarily. Exclusion Criteria: 1. Patients who meet the absolute indications for endoscopic submucosal dissection according to the applicable Chinese gastric cancer treatment guidelines. 2. Contraindications to the use of the lymphatic tracer or to endoscopic examination. 3. Unable to undergo ESD or failure of ESD treatment. 4. Inability to determine the extent of tracer staining or fluorescence mapping. 5. Contraindications to surgery, including clinically significant coagulation disorders or severe cardiopulmonary dysfunction. 6. Previous gastrointestinal surgery, chemotherapy, or radiotherapy. 7. Preoperative imaging indicating bulky, conglomerated, or markedly enlarged metastatic lymph nodes. 8. Concurrent malignancy involving another organ system, or intraoperative confirmation of metastatic gastric cancer or a non-gastric primary malignancy. 9. Pregnancy or breastfeeding. 10. Psychiatric disorders, cognitive impairment, or other conditions that impair the ability to provide informed consent or comply with study procedures. 11. Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.

Locations (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China