Clinical trial · Interventional
Image-Guided Platform-Assisted Sentinel Lymph Node Retrieval in Early Gastric Cancer
Image-Guided Platform-Assisted Intraoperative and Postoperative Sentinel Lymph Node Retrieval in Early Gastric Cancer: A Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image-Guided Retrieval Specimen Platform | Device | — | UNRESOLVED |
| Traditional Palpation-Based Sentinel Lymph Node Retrieval | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Image-Guided Platform
- description
- 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.
- interventionNames
- Device: Image-Guided Retrieval Specimen Platform
- type
- ACTIVE_COMPARATOR
- label
- Traditional Palpation
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
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