Image-Guided Platform-Assisted Sentinel Lymph Node Retrieval in Early Gastric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Friendship Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Image-Guided Retrieval Specimen Platform
DeviceThe 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.
Traditional Palpation-Based Sentinel Lymph Node Retrieval
Procedure/SurgeryThe 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Image-Guided PlatformExperimental treatment 1 intervention
Group B: Traditional PalpationActive comparator 1 intervention
Trial outcomes
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.
Time frame
During the operation, before completion of intraoperative frozen-section pathological assessmentSecondary outcomes
1
Number of Fluorescent Specimens Not Pathologically Confirmed as Lymph Nodes
The number of ICG-fluorescent specimens initially retrieved as fluorescent SLNs but not subsequently confirmed as actual LNs by pathological examination will be recorded for each participant and compared between the two groups.
Time frame
From the operation through completion of permanent pathological examination, within 30 days after surgery2
Number of Occult Lymph Nodes Identified During Permanent Pathological Examination
The number of additional LNs identified during permanent pathological examination of the residual SLB tissue after completion of intraoperative LN retrieval will be recorded for each participant. These LNs correspond to occult lymph nodes (OBNs) that were not identified during intraoperative LN retrieval.
Time frame
From the operation through completion of permanent pathological examination, within 30 days after surgery3
Total Lymph Node Harvest From the Sentinel Lymphatic Basin Specimen
The total LN harvest from the resected SLB specimen will be recorded for each participant. Total LN harvest is defined as the sum of LNs retrieved during intraoperative LN retrieval and additional LNs identified during permanent pathological examination.
Time frame
From the operation through completion of permanent pathological examination, within 30 days after surgery4
Proportion of Participants With Occult Lymph Nodes Identified During Permanent Pathological Examination
The proportion of participants in whom at least one occult LN is identified during permanent pathological examination after completion of intraoperative LN retrieval will be assessed.
Time frame
From the operation through completion of permanent pathological examination, within 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov