Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer（IDEAL Stage 2b） (FLECSS)

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.

Study Overview

• Status: Recruiting
• Conditions: Early Gastric Cancer
• Intervention / Treatment: Procedure: Laparoscopic D2 radical gastrectomy; Procedure: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery

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 Type: Interventional
• Enrollment (Estimated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zheng Zhi, Doctor; Phone Number: +86-010-18311002896; Email: zhengzhi@ccmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Zhi Zheng; Phone Number: 13811132175; Email: 1901055@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: D2 gastrectomy; 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.	Procedure: Laparoscopic D2 radical gastrectomy; 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.
Experimental: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strat; 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.	Procedure: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of surgery to up to 3 years post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Hospitalization Cost		From the time of admission to the time of discharge, assessed up to 3 weeks
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.	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.	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.	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.	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.	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.	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	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.	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.	From date of surgery to up to 5 years post-surgery
30-day postoperative mortality	All-cause mortality occurring within 30 days after surgery.	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	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	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	From the date of surgery to 30 days post-surgery
Rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine		From the date of surgery to 7 days post-surgery
Operation time		At the time of surgery
Operation method		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.	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	From the date of surgery to 30 days post-surgery
Intraoperative Blood Loss	Estimated total volume of blood loss during the surgical procedure	At the time of surgery
Postoperative Length of Stay	Total number of days from the date of surgery to hospital discharge	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	From date of surgery until date of hospital discharge, assessed up to 2 weeks
Gastric Emptying Scintigraphy	It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.	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.	From date of surgery until date of hospital discharge, assessed up to 2 weeks
Serum Total Protein		From 30 days prior to surgery to 5 years post-surgery
Albumin		From 30 days prior to surgery to 5 years post-surgery
Hemoglobin		From 30 days prior to surgery to 5 years post-surgery
Prealbumin		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.	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.	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.	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.	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.	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.	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.	From 30 days prior to surgery to 5 years post-surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: China-Japan Friendship Hospital; Cancer Hospital Chinese Academy of Medical Scienc

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; multicenter; Sentinel Lymph Node; Early Gastric Cancer; Basin Dissection; Safety AND Efficacy; Fluorescence Guided; Laparoscopic-Endoscopic Cooperative Surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: BRWEP2024W162020112 (Other Grant/Funding Number: Beijing Research Ward Excellence Program, BRWEP); 82300646 (Other Grant/Funding Number: National Natural Science Foundation of China); 7232334 (Other Grant/Funding Number: Beijing Natural Science Foundation); D171100006517003 (Other Grant/Funding Number: Beijing Municipal Science & Technology Commission); PX2020001 (Other Grant/Funding Number: Beijing Municipal Administration of Hospitals Incubating Program); PX20240103 (Other Grant/Funding Number: Beijing Municipal Administration of Hospitals Incubating Program); No.2024-2-2028 (Other Grant/Funding Number: Capital's Funds for Health Improvement and Research); Z241100007724004 (Other Grant/Funding Number: Beijing Municipal Science & Technology Commission AI+ Health Collaborative Innovation Cultivation Project); BRWEP2024W162020100 (Other Grant/Funding Number: Beijing Research Ward Excellence Program, BRWEP); YC202401QX0824 (Other Grant/Funding Number: Excellent Plan for Medicine Innovation and Translation project); [ZHKY-2025-1869（B012）] (Other Grant/Funding Number: Beijing Integrated Medical Association Clinical Research Funding Program); No.2024ZD0520600 (Other Grant/Funding Number: Noncommunicable Chronic Diseases-National Science and Technology Major Project Award)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No