LECS with sentinel node navigation for early gastric cancer
Official title: A Prospective, Single-Arm Study of Laparoscopic and Endoscopic Cooperative Surgery (LECS) Combined With Laparoscopic Sentinel Node Navigation Surgery (LSNNS) for Early Gastric Cancer (LENS Trial)
Run by Peking University People's Hospital · NCT07857668 · Data updated 2026-11-12
This study tests whether combining LECS with sentinel node navigation can treat early gastric cancer while preserving stomach function in eligible patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 4, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07857668 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20–80 with a solitary cT1N0M0 gastric adenocarcinoma suitable for laparoscopic surgery and meeting the specified diagnostic criteria.
✕Probably not a fit
Patients with undetected or true nodal metastasis, or those not achieving clear sentinel node status, may not benefit from stomach-preserving options.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm study at a single center evaluating the feasibility, safety, and long-term effectiveness of LECS combined with LSNNS using ICG fluorescence in patients with cT1N0M0 early gastric cancer. Eligible participants undergo intraoperative sentinel lymph node biopsy; those without metastasis receive stomach-preserving, minimally invasive surgery, while those with positive nodes may receive additional tailored resections. The trial includes comprehensive preoperative assessments and postoperative follow-up to monitor oncologic outcomes, organ function, and quality of life. Enrollment is planned for 40 participants aged 20–80 with good performance status and specific tumor criteria.
Why it matters
Potential benefit: If successful, this approach could allow for effective cancer control while preserving stomach function and improving quality of life.
How similar studies have gone: Prior sentinel node mapping and organ-preserving approaches in gastric cancer have shown promise, but this exact LECS+LSNNS combination is exploratory in a single-center setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preoperative biopsy confirming solitary lesion of gastric adenocarcinoma * Preoperative magnifying endoscopy diagnosis of differentiated T1b (\> 3 cm) or undifferentiated T1b * Scheduled to undergo laparoscopic surgery * Age between 20 and 80 years * ECOG performance status of 0 or 1 * Signed written informed consent to participate in this clinical study Exclusion Criteria: * Suitable for endoscopic treatment (e.g., standard ESD indications) * Unsuitable for surgery due to severe comorbidities (such as severe cardiopulmonary diseases) * Pregnant women * Known history of allergy to Indocyanine Green (ICG) * Prior history of upper abdominal surgery (except laparoscopic cholecystectomy) * Prior history of upper abdominal radiation therapy * Coexistence of other malignant tumors within the past 5 years
Where it's running
-
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.