LECS Combined With LSNNS for Early Gastric Cancer (LENS Trial)
ConditionEarly Gastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
The study population consists of hospitalized patients or outpatient candidates diagnosed with cT1N0M0 early gastric adenocarcinoma at Peking University People's Hospital who are scheduled for laparoscopic surgical treatment and fulfill the study eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Procedure: LECS combined with LSNNS
Procedure/SurgeryPatients with cT1N0M0 early gastric cancer will undergo Laparoscopic and Endoscopic Cooperative Surgery (LECS) combined with Laparoscopic Sentinel Node Navigation Surgery (LSNNS).Sentinel Lymph Node Biopsy (LSNNS): Indocyanine green will be injected submucosally via endoscopy or subserosally via laparoscopy around the tumor site. After a 20-minute tracer waiting period, fluorescent sentinel lymph nodes (SNs) will be navigated and harvested laparoscopically for intraoperative frozen section pathological evaluation. Surgical Procedure Based on SN Status:If intraoperative SN status is negative (SBN-): Patients will undergo stomach-preserving surgery using non-exposed LECS techniques, primarily Non-exposed Endoscopic Wall-inversion Surgery (NEWS). If intraoperative SN status is positive (SBN+): Patients will immediately convert to standard laparoscopic gastrectomy with formal D1/D1+ lymph node dissection.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: LECS + LSNNS Group1 intervention
Trial outcomes
Primary outcomes
1
3-Year Disease-Free Survival (DFS)
DFS is defined as the proportion of patients who survive without early gastric cancer recurrence (local, regional, or distant) or death from any cause at 3 years after surgery.
Time frame
3 years post-operationSecondary outcomes
1
Postoperative Complications
The incidence and severity of postoperative complications will be evaluated and graded according to the Clavien-Dindo classification system (Grade I to Grade V), including bleeding, anastomotic/gastric wall leakage, gastroparesis, wound complications, and intra-abdominal infection. The percentage of participants experiencing at least one complication (Grade II or higher) will be reported.
Time frame
Within 30 days post-operation2
Patient-Reported Quality of Life (EORTC QLQ-C30)
Evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100, where higher scores for functional scales represent higher/better levels of functioning, and higher scores for symptom scales represent a higher level of symptomatology.
Time frame
Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.3
Gastric Cancer-Specific Quality of Life (STO22)
Evaluated using the EORTC QLQ-STO22 module. Scores range from 0 to 100, with higher scores indicating worse gastric-specific symptoms (e.g., dysphagia, pain, reflux, eating restrictions).
Time frame
Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.4
5-Year Disease-Free Survival (DFS) and Overall Survival (OS)
5-year DFS is defined as the proportion of recurrence-free patients. 5-year OS is defined as the percentage of patients who are still alive at 5 years post-operation regardless of the cause of death.
Time frame
5 years post-operationSponsors and contacts
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Source ClinicalTrials.gov