Early Gastric CancerLENSNCT07857668
LECS Combined With LSNNS for Early Gastric Cancer (LENS Trial)
An observational study of Early Gastric Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Procedure: LECS combined with LSNNS
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Zhidong Gao, 8601088326600, zhouyushi@pku.edu.cn
About this study
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)
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.
Read the detailed description
Background and Rationale:
Gastric cancer remains a major global health burden, with East Asia bearing the highest incidence. While traditional radical gastrectomy achieves thorough oncological cure through extensive lymphadenectomy, the loss of stomach volume and normal anatomical structure often leads to post-gastrectomy syndromes, malnutrition, and dumping syndrome. Non-exposed Endoscopic Wall-inversion Surgery (NEWS) avoids stomach perforation and tumor seeding, while LSNNS via Indocyanine Green (ICG) mapping accurately identifies first-station drainage lymph nodes to rule out metastasis. Combining NEWS with LSNNS offers a promising minimally invasive strategy that balances oncological safety with optimal organ function preservation. Study Design and Flow:
This is a single-center, prospective, single-arm exploratory study targeting 40 patients with cT1N0M0 early gastric cancer (differentiated T1b > 3 cm or undifferentiated T1b diagnosed by preoperative magnifying endoscopy). Preoperative Baseline Assessment:
Enrolled patients will undergo comprehensive staging and baseline function evaluations, including chest-abdomen-pelvis CT, magnifying endoscopy with biopsy, laboratory nutritional markers (TP, ALB, PA), Electrogastrography (EGG), upper GI contrast study, and quality of life questionnaires (EORTC QLQ-C30 and STO22). Intraoperative Sentinel Node Navigation and Surgery:During surgery, 2 mL (5 mg) of ICG tracer will be injected around the tumor via endoscopic submucosal or laparoscopic subserosal routes. After a 20-minute waiting period, fluorescent sentinel lymph nodes will be navigated and harvested for intraoperative rapid frozen section pathological examination. Intraoperative Decision Path:SN Negative (SBN-): Patients receive stomach-preserving LECS (primarily NEWS) to achieve minimal resection with clear local margins. SN Positive (SBN+): Patients immediately convert to standard laparoscopic gastrectomy with formal D1/D1+ lymph node dissection. Postoperative Management and Rescue Protocol:
If postoperative formal paraffin pathology indicates unexpected lymph node metastasis in patients who underwent LECS, a multidisciplinary team (MDT) discussion will be initiated to decide on completion radical gastrectomy or adjuvant strategies. Follow-up Plan:
Patients will be systematically followed up at 3 months, 1 year, 3 years, and 5 years postoperatively. Evaluation parameters include 3-year and 5-year Disease-Free Survival (DFS), Overall Survival (OS), surgical complications (Clavien-Dindo classification), electrogastrography, nutritional indicators, and QoL scores.
- Conditions
- Early Gastric Cancer
- Being tested
- Procedure: LECS combined with LSNNS
- Keywords
- Laparoscopic and Endoscopic Cooperative Surgery (LECS), Sentinel Node Navigation Surgery (LSNNS), Organ Preservation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: LECS combined with LSNNSProcedure or surgery
Patients 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.
| Study group | Role | What they receive |
|---|---|---|
| LECS + LSNNS Group | Eligible early gastric cancer patients will undergo LSNNS with ICG fluorescence tracer. If sentinel lymph nodes are negative by intraoperative frozen pathology, patients receive LECS (e.g., NEWS). If positive, standard laparoscopic gastrectomy with lymphadenectomy will be performed. Receives: Procedure: Procedure: LECS combined with LSNNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years post-operation
Secondary outcomes (8)
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.
Measured: Within 30 days post-operation
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.
Measured: Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
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).
Measured: Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
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.
Measured: 5 years post-operation
Time to First Postoperative Bowel Flatus
The time interval (in days) from the completion of surgery to the first passage of flatus, serving as a measure of early gastrointestinal functional recovery.
Measured: From date of surgery up to postoperative Day 7
Change in Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated as weight in kilograms divided by the square of height in meters (kg/m^2). The change from baseline to each post-operative follow-up time point will be evaluated to assess postoperative nutritional status.
Measured: Baseline (pre-operation), at hospital discharge (an average of 7 to 14 days post-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
Length of Postoperative Hospital Stay
The duration from the day of surgery to hospital discharge, measured in days, to evaluate short-term postoperative recovery.
Measured: From date of surgery up to hospital discharge (assessed up to 30 days post-operation)
Postoperative 30-Day Mortality Rate
Percentage of participants who die from any cause within 30 days following surgery.
Measured: Within 30 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start4 Aug 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhidong Gao, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857668
- Sponsor's protocol ID
- LENS-v1.1
- Acronym
- LENS
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07857668
- Acronym / sponsor ID
- LENS / LENS-v1.1
- Conditions
- Early Gastric Cancer
- Keywords
- Laparoscopic and Endoscopic Cooperative Surgery (LECS), Sentinel Node Navigation Surgery (LSNNS), Organ Preservation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
Gastric cancer remains a major global health burden, with East Asia bearing the highest incidence. While traditional radical gastrectomy achieves thorough oncological cure through extensive lymphadenectomy, the loss of stomach volume and normal anatomical structure often leads to post-gastrectomy syndromes, malnutrition, and dumping syndrome. Non-exposed Endoscopic Wall-inversion Surgery (NEWS) avoids stomach perforation and tumor seeding, while LSNNS via Indocyanine Green (ICG) mapping accurately identifies first-station drainage lymph nodes to rule out metastasis. Combining NEWS with LSNNS offers a promising minimally invasive strategy that balances oncological safety with optimal organ function preservation. Study Design and Flow:
This is a single-center, prospective, single-arm exploratory study targeting 40 patients with cT1N0M0 early gastric cancer (differentiated T1b > 3 cm or undifferentiated T1b diagnosed by preoperative magnifying endoscopy). Preoperative Baseline Assessment:
Enrolled patients will undergo comprehensive staging and baseline function evaluations, including chest-abdomen-pelvis CT, magnifying endoscopy with biopsy, laboratory nutritional markers (TP, ALB, PA), Electrogastrography (EGG), upper GI contrast study, and quality of life questionnaires (EORTC QLQ-C30 and STO22). Intraoperative Sentinel Node Navigation and Surgery:During surgery, 2 mL (5 mg) of ICG tracer will be injected around the tumor via endoscopic submucosal or laparoscopic subserosal routes. After a 20-minute waiting period, fluorescent sentinel lymph nodes will be navigated and harvested for intraoperative rapid frozen section pathological examination. Intraoperative Decision Path:SN Negative (SBN-): Patients receive stomach-preserving LECS (primarily NEWS) to achieve minimal resection with clear local margins. SN Positive (SBN+): Patients immediately convert to standard laparoscopic gastrectomy with formal D1/D1+ lymph node dissection. Postoperative Management and Rescue Protocol:
If postoperative formal paraffin pathology indicates unexpected lymph node metastasis in patients who underwent LECS, a multidisciplinary team (MDT) discussion will be initiated to decide on completion radical gastrectomy or adjuvant strategies. Follow-up Plan:
Patients will be systematically followed up at 3 months, 1 year, 3 years, and 5 years postoperatively. Evaluation parameters include 3-year and 5-year Disease-Free Survival (DFS), Overall Survival (OS), surgical complications (Clavien-Dindo classification), electrogastrography, nutritional indicators, and QoL scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LECS + LSNNS Group | – | Procedure: Procedure: LECS combined with LSNNSEligible early gastric cancer patients will undergo LSNNS with ICG fluorescence tracer. If sentinel lymph nodes are negative by intraoperative frozen pathology, patients receive LECS (e.g., NEWS). If positive, standard laparoscopic gastrectomy with lymphadenectomy will be performed. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure: LECS combined with LSNNSPatients 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. | Procedure or surgery | LECS + LSNNS Group |
Primary outcome
3-Year Disease-Free Survival (DFS)
Time frame: 3 years post-operation
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.
8 secondary outcomes
Postoperative Complications
Time frame: Within 30 days post-operation
Patient-Reported Quality of Life (EORTC QLQ-C30)
Time frame: Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
Gastric Cancer-Specific Quality of Life (STO22)
Time frame: Baseline (pre-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
5-Year Disease-Free Survival (DFS) and Overall Survival (OS)
Time frame: 5 years post-operation
Time to First Postoperative Bowel Flatus
Time frame: From date of surgery up to postoperative Day 7
Change in Body Mass Index (BMI)
Time frame: Baseline (pre-operation), at hospital discharge (an average of 7 to 14 days post-operation), 3 months, 1 year, 3 years, and 5 years post-operation.
Length of Postoperative Hospital Stay
Time frame: From date of surgery up to hospital discharge (assessed up to 30 days post-operation)
Postoperative 30-Day Mortality Rate
Time frame: Within 30 days post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Gastric Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Disease-Free Survival (DFS) (time frame: 3 years post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.