Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer

NCT ID: NCT06788548

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2029-12-31

Brief 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. 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.

Conditions

Early Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery

Intervention Type: PROCEDURE

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.

LECS-SNNS adopted a left-sided surgical approach. 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). 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.

Fifteen minutes after ICG injection, the SLBs were examined first under white light and then using fluorescence imaging. Staining status was determined by consensus among surgeons and endoscopists.

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.

Group Type: ACTIVE_COMPARATOR

Laparoscopic D2 radical gastrectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

LECS-SNNS adopted a left-sided surgical approach. 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). 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.

Fifteen minutes after ICG injection, the SLBs were examined first under white light and then using fluorescence imaging. Staining status was determined by consensus among surgeons and endoscopists.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Cancer Hospital Chinese Academy of Medical Scienc

UNKNOWN

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zheng Zhi, Doctor

Role: CONTACT

zhengzhi@ccmu.edu.cn

+86-010-18311002896

Facility Contacts

Zhi Zheng

Role: primary

1901055@ccmu.edu.cn

13811132175

Other Identifiers

7232334

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D171100006517003

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PX2020001

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PX20240103

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No.2024-2-2028

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Z241100007724004

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BRWEP2024W162020100

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BRWEP2024W162020112

Identifier Type: OTHER_GRANT

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YC202401QX0824

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

82300646

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

[ZHKY-2025-1869（B012）]

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

No.2024ZD0520600

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BRWEP2024W162020112

Identifier Type: -

Identifier Source: org_study_id