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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Total Number of Sentinel Lymph Nodes Retrieved Intraoperatively From the Sentinel Lymphatic Basin Specimen — During the operation, before completion of intraoperative frozen-section pathological assessment
  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.

Trial sites (1)

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