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NCT Number: NCT06788548

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Zhi Zheng

CONTACT

[email protected]

13811132175

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients without prior gastrointestinal surgery, chemotherapy, or radiotherapy.
  • Patients with normal liver, kidney, heart, lung, and bone marrow function (GPT × 109 /L, PLT>109 /L).
  • Patients capable of understanding and adhering to the research protocol. 6) Patients who can provide written informed consent, either personally or through legal representative.
  • 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.
  • Patients unable to undergo general anesthesia or surgical treatment due to conditions related to other organs, or unwilling to undergo surgery.
  • 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.
  • Pregnant or lactating women. 6) Participants enrolled in other clinical trials. 7) Patients with undeterminable tracer staining range or contraindications to tracer use.
  • Patients who fail to receive or fail ESD therapy. 9) Patients who meet the absolute indication of ESD.

Treatment and study plan

Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery

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. 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 gastrectomy

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.

Primary outcomes

  1. 3 and 5-year disease free survival

    Time frame: From treatment to 3 and 5-years after surgery

Secondary outcomes

  1. 5-year overall survival

    Time frame: From treatment to 5-years after surgery

  2. Mortality (within 30 days after surgery);Unscheduled second surgery (within 30 days after surgery) and Unplanned return to hospital (within 30 days after surgery)

    Time frame: From treatment to 30-days after surgery

  3. rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine;Rates of remedial and additional surgery

    Time frame: From enrollment to 1 week after surgery

  4. Perioperative complication rate (within 30 days after surgery, including bleeding, perforation, lymphatic leakage, respiratory complications, cardiovascular complications, anastomotic fistula

    Time frame: From treatment to 30-days after surgery

    According to the Clavien-Dindo scale, if the postoperative complication grade is higher than grade II, it is considered clinically significant)

  5. Operation time

    Time frame: From treatment to 1 week after surgery

  6. R0 resection rate

    Time frame: From treatment to 1 week after surgery

  7. additional surgical operation rate

    Time frame: From treatment to 5-years after surgery

  8. blood loss

    Time frame: From treatment to 30-days after surgery

  9. postoperative length of stay

    Time frame: From treatment to 30-days after surgery

  10. overall hospitalization cost

    Time frame: From treatment to 5-years after surgery

  11. Gastric emptying scintigraphy result

    Time frame: From treatment to 5-years after surgery

  12. date of gas evacuation

    Time frame: From treatment to 30-days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Zheng Zhi, Doctor

CONTACT

[email protected]

+86-010-18311002896

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • Cancer Hospital Chinese Academy of Medical Scienc
  • China-Japan Friendship Hospital

Registry information

Official study title

Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study

Acronym: FLECSS

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jan 23, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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