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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-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.

Secondary outcomes

  1. 5-year disease-free survival (DFS) rate

    Time frame: From date of surgery to up to 5 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.

  2. 3-year overall survival (OS) rate

    Time frame: From date of surgery to up to 3 years post-surgery

    OS is defined as the time from the date of surgery to death from any cause.

  3. 5-year overall survival (OS) rate

    Time frame: From date of surgery to up to 5 years post-surgery

    OS is defined as the time from the date of surgery to death from any cause.

  4. 3-year recurrence-free survival (RFS) rate

    Time frame: From date of surgery to up to 3 years post-surgery

    RFS is defined as the time from the date of surgery to the first occurrence of disease recurrence.

  5. 5-year recurrence-free survival (RFS) rate

    Time frame: From date of surgery to up to 5 years post-surgery

    RFS is defined as the time from the date of surgery to the first occurrence of disease recurrence.

  6. 3-year disease-specific survival (DSS) rate

    Time frame: From date of surgery to up to 3 years post-surgery

    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.

  7. 5-year disease-specific survival (DSS) rate

    Time frame: From date of surgery to up to 5 years post-surgery

    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

  8. 3-year progression-free survival (PFS) rate

    Time frame: From date of surgery to up to 3 years post-surgery

    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.

  9. 5-year progression-free survival (PFS) rate

    Time frame: From date of surgery to up to 5 years post-surgery

    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.

  10. 30-day postoperative mortality

    Time frame: From the date of surgery to 30 days post-surgery

    All-cause mortality occurring within 30 days after surgery.

  11. 30-day postoperative morbidity

    Time frame: From the date of surgery to 30 days post-surgery

    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

  12. Unscheduled Second Surgery Rate

    Time frame: From the date of surgery to 30 days post-surgery

    Rate of unscheduled reoperation within 30 days after the initial surgery

  13. Unplanned Return to Hospital Rate

    Time frame: From the date of surgery to 30 days post-surgery

    Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery

  14. Rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine

    Time frame: From the date of surgery to 7 days post-surgery

  15. Operation time

    Time frame: At the time of surgery

  16. Operation method

    Time frame: At the time of surgery

  17. R0 resection rate

    Time frame: From date of surgery to 7 days post-surgery

    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.

  18. Remedial and additional surgery rate

    Time frame: From the date of surgery to 30 days post-surgery

    Proportion of patients requiring additional surgical procedures due to intraoperative or postoperative pathological findings

  19. Intraoperative Blood Loss

    Time frame: At the time of surgery

    Estimated total volume of blood loss during the surgical procedure

  20. Postoperative Length of Stay

    Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks

    Total number of days from the date of surgery to hospital discharge

  21. Average Length of Stay

    Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks

    Average number of days from the date of surgery to hospital discharge

  22. Overall Hospitalization Cost

    Time frame: From the time of admission to the time of discharge, assessed up to 3 weeks

  23. Gastric Emptying Scintigraphy

    Time frame: From 30 days prior to surgery to 5 years post-surgery

    It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.

  24. Time to First Flatus

    Time frame: From date of surgery until date of hospital discharge, assessed up to 2 weeks

    Time from the date of surgery to the first passage of flatus, indicating recovery of gastrointestinal motility.

  25. Serum Total Protein

    Time frame: From 30 days prior to surgery to 5 years post-surgery

  26. Albumin

    Time frame: From 30 days prior to surgery to 5 years post-surgery

  27. Hemoglobin

    Time frame: From 30 days prior to surgery to 5 years post-surgery

  28. Prealbumin

    Time frame: From 30 days prior to surgery to 5 years post-surgery

  29. Prognostic Nutritional Index (PNI)

    Time frame: From 30 days prior to surgery to 5 years post-surgery

    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.

  30. Postoperative gastroscopy composite adverse findings

    Time frame: From date of surgery to up to 5 years post-surgery

    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.

  31. Postoperative CT composite findings

    Time frame: From date of surgery to up to 5 years post-surgery

    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.

  32. Postoperative histopathological composite findings

    Time frame: From date of surgery to up to 5 years post-surgery

    Proportion of participants with positive findings for malignancy on histopathological examination of biopsy specimens obtained during scheduled follow-up endoscopy or additional surgery.

  33. EORTC QLQ-C30

    Time frame: From 30 days prior to surgery to 5 years post-surgery

    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.

  34. EORTC QLQ-STO22

    Time frame: From 30 days prior to surgery to 5 years post-surgery

    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.

  35. PGSAS-45

    Time frame: From 30 days prior to surgery to 5 years post-surgery

    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.

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
Aug 21, 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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