Early Gastric CancerFLECSSNCT06788548
Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer（IDEAL Stage 2b）
A study testing Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery and Laparoscopic D2 radical gastrectomy in people with Early Gastric Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery and Laparoscopic D2 radical gastrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2024to 30 Dec 2029
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients aged 18-80 years, regardless of gender. 2) Patients with Eastern Cooperative Oncology Group (ECOG) score ≤ 2 and American Society of Anesthesiologists (ASA) score ≤ 2 who are candidates for a curative D2 gastrectomy.
- 3) Patients without prior gastrointestinal surgery, chemotherapy, or radiotherapy.
- 4) Patients with normal liver, kidney, heart, lung, and bone marrow function (GPT × 109 /L, PLT>109 /L).
- 5) Patients capable of understanding and adhering to the research protocol. 6) Patients who can provide written informed consent, either personally or through legal representative.
- 7) Patients with cT1N0M0 gastric cancer or after non-curative ESD resection, according to the UICC TNM staging system, 8th edition.
Who cannot join
- 1) Patients with a contraindication for gastroscopy. 2) Patients with uncontrollable diseases, such as coagulation disorders, epilepsy, central nervous system diseases or mental disorders, cardiopulmonary insufficiency, unstable angina, myocardial infarction, a cerebrovascular accident that occurred within 6 months, and other surgical contraindications.
- 3) Patients unable to undergo general anesthesia or surgical treatment due to conditions related to other organs, or unwilling to undergo surgery.
- 4) Patients with gastric stump cancer, recurrent gastric cancer, multiple primary malignant tumors in the abdominopelvic cavity, or a history of other malignant tumors within the previous 5 years.
- 5) Pregnant or lactating women. 6) Participants enrolled in other clinical trials. 7) Patients with undeterminable tracer staining range or contraindications to tracer use.
- 8) Patients who fail to receive or fail ESD therapy. 9) Patients who meet the absolute indication of ESD.
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
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Zhi Zheng, 13811132175, 1901055@ccmu.edu.cn
About this study
Official title: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study
The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.
Read the detailed description
The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.
- Conditions
- Early Gastric Cancer
- Being tested
- Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery, Laparoscopic D2 radical gastrectomy
- Keywords
- Early Gastric Cancer, Sentinel Lymph Node, Basin Dissection, Laparoscopic surgery, Safety AND Efficacy, Fluorescence Guided, Laparoscopic-Endoscopic Cooperative Surgery, multicenter
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation SurgeryProcedure or surgery
Patients without prior ESD received ESD with laparoscopic sentinel basin dissection (LSBD) for ESD resectable lesions, otherwise patients received laparoscopic-endoscopic cooperative regional gastrectomy (LRG) with LSBD. For patients with prior non-curative ESD, LSBD alone was performed if margins were negative, otherwise LRG with LSBD was conducted. Intraoperative frozen-section pathological examination of the horizontal resection margin of the ESD or full-thickness specimen.
During laparoscopic sentinel node basin dissection (LSBD), indocyanine green (ICG) (2 mL, 2.5 mg/mL) was endoscopically injected into the submucosal layer at four quadrants around the marking points (0.5 mL per quadrant). Fifteen minutes after ICG injection, sentinel lymph node basins (SLBs) were defined as the area within a 2 cm margin of the detected fluorescence stained nodes, which were marked with laparoscopic clips.
Laparoscopic D2 radical gastrectomyProcedure or surgery
Preparation: The patient is positioned supine with general anesthesia. An orogastric tube and Foley catheter are inserted. Antibiotics are administered, and sequential stockings are applied. Port Placement: Pneumoperitoneum is created via a Veress needle at the umbilicus. Working ports are placed in the upper quadrants, with a fifth port for liver retraction. Abdominal Exploration: The abdomen is inspected for metastases, and peritoneal cytology is performed. Dissection and Lymph Node Removal: The lesser omentum is divided near the liver, reaching the cardia and diaphragm. The gastrocolic ligament is divided along the transverse colon. Lymph node dissection begins along the splenic artery, then proceeds to the left gastric artery and celiac nodes. The left gastric vessels are controlled with endoclips.After lymph node dissection, distal subtotal gastrectomy is performed. Digestive tract reconstruction is typically done through a mini-laparotomy.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strat | Experimental | Laparoscopic-endoscopic cooperative surgery (LECS) offers a more targeted approach through the integration of the complementary strengths of endoscopy and laparoscopy. LECS enables accurate targeting, optimal resection margins and tissue sparing excision. Consequently, LECS better preserves gastric architecture and function, potentially leading to enhanced postoperative recovery and QoL. Nevertheless, current evidence supporting LECS for SNNS remains limited. Receives: Procedure: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery |
| D2 gastrectomy | Active comparator | A preoperative contrast-enhanced abdominal CT scan is conducted to assess the lesion's location, tumor dimensions, and lymph node metastasis (LNM). Preoperative endoscopic dye injection or intraoperative endoscopic localization is utilized to accurately identify the tumor site and ensure adequate resection margins. The extent of lymph node dissection (LND) adheres to the Japanese gastric cancer treatment guidelines 2023 (6th edition)[4]. Specifically, D2 distal gastrectomy encompasses lymph nodes No. 1, 3, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, and 12a. D2 proximal gastrectomy includes nodes 1, 2, 3a, 4sa, 4sb, 7, 8a, 9, 11p, and 12a, while D2 total gastrectomy involves nodes 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, and 12a. Receives: Procedure: Laparoscopic D2 radical gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival (DFS) rate
DFS is defined as the time from the date of surgery to the date of first documented tumor recurrence, metastasis, or death from any cause.
Measured: From date of surgery to up to 3 years post-surgery
Secondary outcomes (35)
5-year disease-free survival (DFS) rate
DFS is defined as the time from the date of surgery to the date of first documented tumor recurrence, metastasis, or death from any cause.
Measured: From date of surgery to up to 5 years post-surgery
3-year overall survival (OS) rate
OS is defined as the time from the date of surgery to death from any cause.
Measured: From date of surgery to up to 3 years post-surgery
5-year overall survival (OS) rate
OS is defined as the time from the date of surgery to death from any cause.
Measured: From date of surgery to up to 5 years post-surgery
3-year recurrence-free survival (RFS) rate
RFS is defined as the time from the date of surgery to the first occurrence of disease recurrence.
Measured: From date of surgery to up to 3 years post-surgery
5-year recurrence-free survival (RFS) rate
RFS is defined as the time from the date of surgery to the first occurrence of disease recurrence.
Measured: From date of surgery to up to 5 years post-surgery
3-year disease-specific survival (DSS) rate
DSS is defined as the length of time that the patients survived from the time of randomization or treatment initiation until death from the specific disease in question.
Measured: From date of surgery to up to 3 years post-surgery
5-year disease-specific survival (DSS) rate
DSS is defined as the length of time that the patients survived from the time of randomization or treatment initiation until death from the specific disease in question
Measured: From date of surgery to up to 5 years post-surgery
3-year progression-free survival (PFS) rate
PFS is defined as the time from the date of surgery to the first occurrence of either disease progression or death from any cause. Disease progression includes recurrence, metastasis, or progression of residual disease.
Measured: From date of surgery to up to 3 years post-surgery
5-year progression-free survival (PFS) rate
PFS is defined as the time from the date of surgery to the first occurrence of either disease progression or death from any cause. Disease progression includes recurrence, metastasis, or progression of residual disease.
Measured: From date of surgery to up to 5 years post-surgery
30-day postoperative mortality
All-cause mortality occurring within 30 days after surgery.
Measured: From the date of surgery to 30 days post-surgery
30-day postoperative morbidity
Postoperative complications occurring within 30 days will be recorded, including bleeding, perforation, lymphatic leakage, respiratory complications, cardiovascular complications, anastomotic fistula, according to the Clavien-Dindo scale
Measured: From the date of surgery to 30 days post-surgery
Unscheduled Second Surgery Rate
Rate of unscheduled reoperation within 30 days after the initial surgery
Measured: From the date of surgery to 30 days post-surgery
Unplanned Return to Hospital Rate
Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery
Measured: From the date of surgery to 30 days post-surgery
Rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine
Measured: From the date of surgery to 7 days post-surgery
Operation time
Measured: At the time of surgery
Operation method
Measured: At the time of surgery
R0 resection rate
Proportion of patients with no residual tumor microscopically confirmed on both the primary tumor resection margins and resected lymph nodes, assessed by postoperative pathological examination.
Measured: From date of surgery to 7 days post-surgery
Remedial and additional surgery rate
Proportion of patients requiring additional surgical procedures due to intraoperative or postoperative pathological findings
Measured: From the date of surgery to 30 days post-surgery
Intraoperative Blood Loss
Estimated total volume of blood loss during the surgical procedure
Measured: At the time of surgery
Postoperative Length of Stay
Total number of days from the date of surgery to hospital discharge
Measured: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Average Length of Stay
Average number of days from the date of surgery to hospital discharge
Measured: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Overall Hospitalization Cost
Measured: From the time of admission to the time of discharge, assessed up to 3 weeks
Gastric Emptying Scintigraphy
It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.
Measured: From 30 days prior to surgery to 5 years post-surgery
Time to First Flatus
Time from the date of surgery to the first passage of flatus, indicating recovery of gastrointestinal motility.
Measured: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Serum Total Protein
Measured: From 30 days prior to surgery to 5 years post-surgery
Albumin
Measured: From 30 days prior to surgery to 5 years post-surgery
Hemoglobin
Measured: From 30 days prior to surgery to 5 years post-surgery
Prealbumin
Measured: From 30 days prior to surgery to 5 years post-surgery
Prognostic Nutritional Index (PNI)
It is a combined score based on serum albumin level and total lymphocyte count. It is calculated as 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (cells/μL). Higher scores indicate better nutritional and immunological status.
Measured: From 30 days prior to surgery to 5 years post-surgery
Postoperative gastroscopy composite adverse findings
Proportion of participants with any of the following adverse findings on surveillance endoscopy: poor anastomotic healing, residual lesions, metachronous lesions, or local recurrence. Participants are counted once if they meet any of these criteria.
Measured: From date of surgery to up to 5 years post-surgery
Postoperative CT composite findings
Proportion of participants with any of the following adverse findings on contrast-enhanced CT of the chest, abdomen, and pelvis: local recurrence, distant metastasis, or abnormal lymph nodes.
Measured: From date of surgery to up to 5 years post-surgery
Postoperative histopathological composite findings
Proportion of participants with positive findings for malignancy on histopathological examination of biopsy specimens obtained during scheduled follow-up endoscopy or additional surgery.
Measured: From date of surgery to up to 5 years post-surgery
EORTC QLQ-C30
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC-QLQ-C30) includes 30 items measuring functional, symptomatic, and global quality-of-life domains. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
Measured: From 30 days prior to surgery to 5 years post-surgery
EORTC QLQ-STO22
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Module 22(EORTC-QLQ-STO22) supplement contains 22 items assessing symptoms and concerns specific to gastric cancer. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden.
Measured: From 30 days prior to surgery to 5 years post-surgery
PGSAS-45
The Postgastrectomy Syndrome Assessment Scale 45(PGSAS-45), consisting of 45 items, will be used to comprehensively evaluate postgastrectomy symptoms, digestive status, and daily life functions. All subscale scores are linearly transformed to a 0-100 range. For symptom-related subscales, higher scores indicate greater symptom burden; for functional and quality of life subscales, higher scores indicate better functioning or quality of life.
Measured: From 30 days prior to surgery to 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start3 Feb 2024
- Primary completion1 Nov 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Cancer Hospital Chinese Academy of Medical Scienc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788548
- Sponsor's protocol ID
- BRWEP2024W162020112
- Other IDs
- 7232334, D171100006517003, PX2020001, PX20240103, No.2024-2-2028, Z241100007724004, BRWEP2024W162020100, BRWEP2024W162020112
- Acronym
- FLECSS
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng Z, Wang Z, Jian Y, Xu R, Zhao Y, Liu K, Yin J, Sun X, Zhu S, Chen G, Zhang J, Li P, Zhang Z, Zhang S. Non-exposure omental sealing endoscopic full-thickness resection (NEOS-EFTR) with sentinel node navigation surgery for early gastric cancer: a case series. Transl Gastroenterol Hepatol. 2026 Aug 26;11:109. doi: 10.21037/tgh-2026-0116. eCollection 2026.
PubMed 42866832
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT06788548
- Acronym / sponsor ID
- FLECSS / BRWEP2024W162020112
- Conditions
- Early Gastric Cancer
- Keywords
- Early Gastric Cancer, Sentinel Lymph Node, Basin Dissection, Laparoscopic surgery, Safety AND Efficacy, Fluorescence Guided, Laparoscopic-Endoscopic Cooperative Surgery, multicenter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Cancer Hospital Chinese Academy of Medical Scienc
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 23 Jan 2025 (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.
The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.
Detailed description
The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strat | Experimental | Procedure: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation SurgeryLaparoscopic-endoscopic cooperative surgery (LECS) offers a more targeted approach through the integration of the complementary strengths of endoscopy and laparoscopy. LECS enables accurate targeting, optimal resection margins and tissue sparing excision. Consequently, LECS better preserves gastric architecture and function, potentially leading to enhanced postoperative recovery and QoL. Nevertheless, current evidence supporting LECS for SNNS remains limited. |
| D2 gastrectomy | Active comparator | Procedure: Laparoscopic D2 radical gastrectomyA preoperative contrast-enhanced abdominal CT scan is conducted to assess the lesion's location, tumor dimensions, and lymph node metastasis (LNM). Preoperative endoscopic dye injection or intraoperative endoscopic localization is utilized to accurately identify the tumor site and ensure adequate resection margins. The extent of lymph node dissection (LND) adheres to the Japanese gastric cancer treatment guidelines 2023 (6th edition)[4]. Specifically, D2 distal gastrectomy encompasses lymph nodes No. 1, 3, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, and 12a. D2 proximal gastrectomy includes nodes 1, 2, 3a, 4sa, 4sb, 7, 8a, 9, 11p, and 12a, while D2 total gastrectomy involves nodes 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, and 12a. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) Patients aged 18-80 years, regardless of gender. 2) Patients with Eastern Cooperative Oncology Group (ECOG) score ≤ 2 and American Society of Anesthesiologists (ASA) score ≤ 2 who are candidates for a curative D2 gastrectomy.
- 3) Patients without prior gastrointestinal surgery, chemotherapy, or radiotherapy.
- 4) Patients with normal liver, kidney, heart, lung, and bone marrow function (GPT × 109 /L, PLT>109 /L).
- 5) Patients capable of understanding and adhering to the research protocol. 6) Patients who can provide written informed consent, either personally or through legal representative.
- 7) Patients with cT1N0M0 gastric cancer or after non-curative ESD resection, according to the UICC TNM staging system, 8th edition.
Key exclusion criteria (5 listed)
- 1) Patients with a contraindication for gastroscopy. 2) Patients with uncontrollable diseases, such as coagulation disorders, epilepsy, central nervous system diseases or mental disorders, cardiopulmonary insufficiency, unstable angina, myocardial infarction, a cerebrovascular accident that occurred within 6 months, and other surgical contraindications.
- 3) Patients unable to undergo general anesthesia or surgical treatment due to conditions related to other organs, or unwilling to undergo surgery.
- 4) Patients with gastric stump cancer, recurrent gastric cancer, multiple primary malignant tumors in the abdominopelvic cavity, or a history of other malignant tumors within the previous 5 years.
- 5) Pregnant or lactating women. 6) Participants enrolled in other clinical trials. 7) Patients with undeterminable tracer staining range or contraindications to tracer use.
- 8) Patients who fail to receive or fail ESD therapy. 9) Patients who meet the absolute indication of ESD.
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 |
|---|---|---|
| Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation SurgeryPatients without prior ESD received ESD with laparoscopic sentinel basin dissection (LSBD) for ESD resectable lesions, otherwise patients received laparoscopic-endoscopic cooperative regional gastrectomy (LRG) with LSBD. For patients with prior non-curative ESD, LSBD alone was performed if margins were negative, otherwise LRG with LSBD was conducted. Intraoperative frozen-section pathological examination of the horizontal resection margin of the ESD or full-thickness specimen. During laparoscopic sentinel node basin dissection (LSBD), indocyanine green (ICG) (2 mL, 2.5 mg/mL) was endoscopically injected into the submucosal layer at four quadrants around the marking points (0.5 mL per quadrant). Fifteen minutes after ICG injection, sentinel lymph node basins (SLBs) were defined as the area within a 2 cm margin of the detected fluorescence stained nodes, which were marked with laparoscopic clips. | Procedure or surgery | Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strat |
| Laparoscopic D2 radical gastrectomyPreparation: The patient is positioned supine with general anesthesia. An orogastric tube and Foley catheter are inserted. Antibiotics are administered, and sequential stockings are applied. Port Placement: Pneumoperitoneum is created via a Veress needle at the umbilicus. Working ports are placed in the upper quadrants, with a fifth port for liver retraction. Abdominal Exploration: The abdomen is inspected for metastases, and peritoneal cytology is performed. Dissection and Lymph Node Removal: The lesser omentum is divided near the liver, reaching the cardia and diaphragm. The gastrocolic ligament is divided along the transverse colon. Lymph node dissection begins along the splenic artery, then proceeds to the left gastric artery and celiac nodes. The left gastric vessels are controlled with endoclips.After lymph node dissection, distal subtotal gastrectomy is performed. Digestive tract reconstruction is typically done through a mini-laparotomy. | Procedure or surgery | D2 gastrectomy |
Primary outcome
3-year disease-free survival (DFS) rate
Time frame: From date of surgery to up to 3 years post-surgery
DFS is defined as the time from the date of surgery to the date of first documented tumor recurrence, metastasis, or death from any cause.
35 secondary outcomes
5-year disease-free survival (DFS) rate
Time frame: From date of surgery to up to 5 years post-surgery
3-year overall survival (OS) rate
Time frame: From date of surgery to up to 3 years post-surgery
5-year overall survival (OS) rate
Time frame: From date of surgery to up to 5 years post-surgery
3-year recurrence-free survival (RFS) rate
Time frame: From date of surgery to up to 3 years post-surgery
5-year recurrence-free survival (RFS) rate
Time frame: From date of surgery to up to 5 years post-surgery
3-year disease-specific survival (DSS) rate
Time frame: From date of surgery to up to 3 years post-surgery
5-year disease-specific survival (DSS) rate
Time frame: From date of surgery to up to 5 years post-surgery
3-year progression-free survival (PFS) rate
Time frame: From date of surgery to up to 3 years post-surgery
5-year progression-free survival (PFS) rate
Time frame: From date of surgery to up to 5 years post-surgery
30-day postoperative mortality
Time frame: From the date of surgery to 30 days post-surgery
30-day postoperative morbidity
Time frame: From the date of surgery to 30 days post-surgery
Unscheduled Second Surgery Rate
Time frame: From the date of surgery to 30 days post-surgery
Unplanned Return to Hospital Rate
Time frame: From the date of surgery to 30 days post-surgery
Rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine
Time frame: From the date of surgery to 7 days post-surgery
Operation time
Time frame: At the time of surgery
Operation method
Time frame: At the time of surgery
R0 resection rate
Time frame: From date of surgery to 7 days post-surgery
Remedial and additional surgery rate
Time frame: From the date of surgery to 30 days post-surgery
Intraoperative Blood Loss
Time frame: At the time of surgery
Postoperative Length of Stay
Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Average Length of Stay
Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Overall Hospitalization Cost
Time frame: From the time of admission to the time of discharge, assessed up to 3 weeks
Gastric Emptying Scintigraphy
Time frame: From 30 days prior to surgery to 5 years post-surgery
Time to First Flatus
Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks
Serum Total Protein
Time frame: From 30 days prior to surgery to 5 years post-surgery
Albumin
Time frame: From 30 days prior to surgery to 5 years post-surgery
Hemoglobin
Time frame: From 30 days prior to surgery to 5 years post-surgery
Prealbumin
Time frame: From 30 days prior to surgery to 5 years post-surgery
Prognostic Nutritional Index (PNI)
Time frame: From 30 days prior to surgery to 5 years post-surgery
Postoperative gastroscopy composite adverse findings
Time frame: From date of surgery to up to 5 years post-surgery
Postoperative CT composite findings
Time frame: From date of surgery to up to 5 years post-surgery
Postoperative histopathological composite findings
Time frame: From date of surgery to up to 5 years post-surgery
EORTC QLQ-C30
Time frame: From 30 days prior to surgery to 5 years post-surgery
EORTC QLQ-STO22
Time frame: From 30 days prior to surgery to 5 years post-surgery
PGSAS-45
Time frame: From 30 days prior to surgery to 5 years post-surgery
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 21 Aug 2026.
- Derived from this study: PubMed 42866832Zheng Z, Wang Z, Jian Y, Xu R, Zhao Y, Liu K, Yin J, Sun X, Zhu S, Chen G, Zhang J, Li P, Zhang Z, Zhang S. Non-exposure omental sealing endoscopic full-thickness resection (NEOS-EFTR) with sentinel node navigation surgery for early gastric cancer: a case series. Transl Gastroenterol Hepatol. 2026 Aug 26;11:109. doi: 10.21037/tgh-2026-0116. eCollection 2026.
- Individual participant dataSharing planned: No
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Gastro Oesophageal Cancer
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?
A study testing Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery and Laparoscopic D2 radical gastrectomy in people with Early Gastric Cancer, run by Beijing Friendship 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 5 inclusion and 5 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 21 Aug 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?
Contact Zheng Zhi, Doctor (+86-010-18311002896, zhengzhi@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival (DFS) rate (time frame: From date of surgery to up to 3 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788548, which also lists 1 linked publication.
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 21 Aug 2026.