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

NCT07835087 | Recruiting

• 1 other identifier: 2026-P2-489-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Gastric Cancer; Gastric Adenocarcinoma

Keywords

Sentinel lymph node; Sentinel lymphatic basin; Sentinel lymph node navigation surgery; Laparoscopic-endoscopic cooperative surgery; Artificial intelligence; Deep learning; Indocyanine green; Fluorescence navigation; Lymph node retrieval; Pathological examination; Specimen processing; Early gastric cancer

Outcome Measures

Primary Outcomes (1)

• Total Number of Sentinel Lymph Nodes Retrieved Intraoperatively From the Sentinel Lymphatic Basin Specimen

  The primary outcome is the per-participant total number of SLNs retrieved from the resected SLB specimen and submitted for intraoperative frozen-section pathological examination. The total number is defined as the sum of fluorescent SLNs identified during initial fluorescence-guided retrieval (SBNs) and additional non-fluorescent LNs retrieved from the residual SLB tissue during subsequent LN retrieval (BNs). The total number of intraoperatively retrieved SLNs will be compared between the Image-Guided Platform group and the Traditional Palpation group.

  During the operation, before completion of intraoperative frozen-section pathological assessment

Secondary Outcomes (11)

• Number of Fluorescent Specimens Not Pathologically Confirmed as Lymph Nodes

  From the operation through completion of permanent pathological examination, within 30 days after surgery

• Number of Occult Lymph Nodes Identified During Permanent Pathological Examination

  From the operation through completion of permanent pathological examination, within 30 days after surgery

• Total Lymph Node Harvest From the Sentinel Lymphatic Basin Specimen

  From the operation through completion of permanent pathological examination, within 30 days after surgery

• Proportion of Participants With Occult Lymph Nodes Identified During Permanent Pathological Examination

  From the operation through completion of permanent pathological examination, within 30 days after surgery

• Lymph Node-Level Concordance Rate Between Intraoperative Frozen-Section and Permanent Pathological Examination

  From the operation through completion of permanent pathological examination, within 30 days after surgery

Study Arms (2)

Image-Guided Platform

EXPERIMENTAL

Participants in this arm will undergo standardized LECS-SNNS with indocyanine green (ICG) fluorescence mapping. Following initial retrieval of fluorescent SLNs, the remaining SLB tissue will be placed on the Image-Guided Platform for radiographic and optical imaging. The acquired images will be analyzed using a deep learning model to identify and localize suspected LNs. Physicians will subsequently retrieve suspected LNs according to the image-guided and model-generated localization results. Supplementary visual inspection and manual palpation will then be performed when appropriate to identify any additional LNs.

Device: Image-Guided Retrieval Specimen Platform

Traditional Palpation

ACTIVE COMPARATOR

Participants in this arm will undergo the same standardized LECS-SNNS and ICG fluorescence mapping procedure. Following initial retrieval of fluorescent SLNs, the remaining SLB tissue will be systematically examined by experienced physicians using standardized dissection, visual inspection, and manual palpation to identify and retrieve suspected LNs without image-guided or deep learning-assisted localization.

Procedure: Traditional Palpation-Based Sentinel Lymph Node Retrieval

Interventions

Image-Guided Retrieval Specimen Platform DEVICE

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.

Image-Guided Platform

Traditional Palpation-Based Sentinel Lymph Node Retrieval PROCEDURE

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.

Traditional Palpation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years, inclusive.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and considered able to tolerate surgery and anesthesia.
• Histologically confirmed gastric adenocarcinoma based on preoperative endoscopic biopsy.
• 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.
• Adequate hepatic, renal, cardiac, pulmonary, and bone marrow function to tolerate the planned surgical and perioperative management.
• Considered clinically suitable for laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS).
• Able to understand the study procedures and provide written informed consent voluntarily.

You may not qualify if:

• Patients who meet the absolute indications for endoscopic submucosal dissection according to the applicable Chinese gastric cancer treatment guidelines.
• Contraindications to the use of the lymphatic tracer or to endoscopic examination.
• Unable to undergo ESD or failure of ESD treatment.
• Inability to determine the extent of tracer staining or fluorescence mapping.
• Contraindications to surgery, including clinically significant coagulation disorders or severe cardiopulmonary dysfunction.
• Previous gastrointestinal surgery, chemotherapy, or radiotherapy.
• Preoperative imaging indicating bulky, conglomerated, or markedly enlarged metastatic lymph nodes.
• Concurrent malignancy involving another organ system, or intraoperative confirmation of metastatic gastric cancer or a non-gastric primary malignancy.
• Pregnancy or breastfeeding.
• Psychiatric disorders, cognitive impairment, or other conditions that impair the ability to provide informed consent or comply with study procedures.
• Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Zhi Zheng, MD

CONTACT

+86-18311002896; zhengzhi@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will remain unaware of their assigned LN retrieval group. Pathologists responsible for final LN counting, histopathological assessment, and determination of LN metastatic status will be blinded to group allocation. All specimens will be labeled using standardized participant and specimen codes without information indicating group assignment. Because of the nature of the intervention, personnel operating the Image-Guided Platform and physicians performing LN retrieval cannot be blinded. Statistical analyses will be performed using coded group labels until completion of the prespecified analyses whenever feasible.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Surgeon

Model Details: 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 the same standardized laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS) and initial fluorescence-guided sentinel lymph node (SLN) retrieval. The randomized intervention applies to subsequent lymph node (LN) retrieval from the residual sentinel lymphatic basin (SLB) tissue.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start: August 14, 2026
• Primary Completion (Estimated): August 14, 2027
• Study Completion (Estimated): August 14, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)