Image-guided platform helps find sentinel lymph nodes in early gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center, randomized trial, patients with early gastric cancer will undergo LECS-SNNS with standard fluorescence mapping. Participants are randomized 1:1 to either the image-guided platform plus deep learning assistance or traditional palpation for sentinel lymph node retrieval. All will receive fluorescent lymph node mapping with indocyanine green and initial retrieval based on visual cues, with the experimental group using the platform to identify additional suspected nodes. The study aims to determine if the platform improves accuracy or efficiency of SLN retrieval and may inform intraoperative decision-making and downstream pathology. The trial is designed to be superiority-focused and uses computer-generated randomization with allocation concealment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Friendship Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Zhi Zheng, MD
• Email: zhengzhi@ccmu.edu.cn
• Phone: +86-18311002896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.