NCT07857668Recruiting
LECS Combined With LSNNS for Early Gastric Cancer (LENS Trial)
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)
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
Early gastric cancer (EGC) is traditionally treated with either endoscopic resection or standard laparoscopic gastrectomy with formal lymph node dissection. However, endoscopic resection cannot evaluate or treat regional lymph node metastasis, whereas standard surgery significantly impairs postoperative gastric physiological function and patient quality of life (QoL). The LENS trial is a prospective, single-arm clinical study designed to evaluate the feasibility, safety, and long-term efficacy of Laparoscopic and Endoscopic Cooperative Surgery (LECS) combined with Laparoscopic Sentinel Node Navigation Surgery (LSNNS) using Indocyanine Green (ICG) fluorescence tracing for patients with cT1N0M0 early gastric cancer. In this trial, eligible patients will undergo intraoperative sentinel lymph node (SN) biopsy guided by ICG. Patients with negative SN status will receive stomach-preserving surgery (primarily Non-exposed Endoscopic Wall-inversion Surgery, NEWS), while those with positive SN status will convert to standard laparoscopic gastrectomy. The primary goal is to confirm whether this combined procedure provides long-term oncological safety comparable to standard radical gastrectomy, while significantly improving postoperative gastric function, nutritional status, and quality of life.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 12 Sept 2026
- Start date
- 4 Aug 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07857668
What you commit to
- Study type: Observational
- Planned participants: 40
- From 4 Aug 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of upper abdominal surgery (except laparoscopic cholecystectomy)
- Prior history of upper abdominal radiation therapy
Other illness
- Unsuitable for surgery due to severe comorbidities (such as severe cardiopulmonary diseases)
- Known history of allergy to Indocyanine Green (ICG)
- Coexistence of other malignant tumors within the past 5 years
Other
- Suitable for endoscopic treatment (e.g., standard ESD indications)
- Pregnant women
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.