💬In plain words
What the trial is, and whether it could suit you
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 t
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📋 Eligibility rules (as published)
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.
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