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NCT Number: NCT06945718

Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Extended Lymphadenectomy Beyond D2 for Locally Advanced Gastric Cancer (FUGES-30)

Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

Changming Huang, M.D., Ph.D.

CONTACT

[email protected]

+86-133-6591-0253

Changming Huang, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent

Exclusion criteria

Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) History of previous gastric surgery (including ESD/EMR for gastric cancer) Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky lymph nodes in D3 region.

Other malignant disease within the past 5 years History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement for simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1 (forced expiratory volume in one second)<50% of predicted values Diffuse invasive gastric cancer Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum History of an iodine allergy Patients who declined laparoscopic surgery

Treatment and study plan

beyond D2 regional lymph node dissection

Procedure

dissect the lymph nodes outside the extent of D2 LN region.

Primary outcomes

  1. 3-year disease free survival rate

    Time frame: 3 years

    Disease-free survival is calculated from the day of surgery to the day of recurrence or death

Secondary outcomes

  1. Total number of retrieved lymph nodes

    Time frame: 30 days

    Total number of retrieved lymph nodes

  2. Noncompliance rate of lymph node dissection

    Time frame: 30 days

    The LN dissection rate was determined by the number of patients in whom a LN station was harvested divided by the total number of patients who required retrieval at the corresponding LN station. Within the scope of D2 dissection, LN noncompliance was defined as the absence of LNs that should have been resected from > 1 LN station.

  3. Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A

    Time frame: 30 days

    Relationship between the number of fluorescent lymph nodes in group A and total number of lymph nodes in group A

  4. Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)

    Time frame: 30 days

    The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (True positive rate).

  5. Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)

    Time frame: 30 days

    The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate).

  6. Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)

    Time frame: 30 days

    The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group A (True negative rate).

  7. Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)

    Time frame: 30 days

    The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group A (false negative rate).

  8. Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B

    Time frame: 30 days

    Relationship between the number of fluorescent lymph nodes in group B and total number of lymph nodes in group B

  9. Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)

    Time frame: 30 days

    The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group B (True positive rate).

  10. Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)

    Time frame: 30 days

    The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate).

  11. Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)

    Time frame: 30 days

    The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group B (True negative rate).

  12. Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)

    Time frame: 30 days

    The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group B (false negative rate).

  13. Number of metastatic lymph nodes

    Time frame: 30 days

    Number of metastatic lymph nodes

  14. Metastasis rate of lymph nodes

    Time frame: 30 days

    Metastasis rate of lymph nodes

  15. Postoperative complications

    Time frame: 30 days

    Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification.

  16. Mortality rates

    Time frame: 30 days

    Patient died during hospitalization.

  17. 3-year overall survival rate

    Time frame: 3 years

    3-year overall survival rate

  18. 3-year recurrence pattern

    Time frame: 3 years

    3-year recurrence pattern

  19. Postoperative recovery course

    Time frame: 30 days

    Time to first flatus after surgery, time to first ambulation after surgery, time to first liquid diet after surgery, time to first semi-liquid diet after surgery, length of hospital stay after surgery.

  20. The incidence of intraoperative complications

    Time frame: 30 days

    Intraoperative complications were defined as bleeding due to named vessel injury, injury to visceral organs, mechanical factor-related problems, cardiopulmonary dysfunction due to hypercapnia, and other complications

  21. Inflammatory and immune response

    Time frame: 7 days

    the values of hemoglobin, prealbumin, albumin, C-reactive protein, and white blood cell count from peripheral blood before the operation and on postoperative day 1, 3, 5 are recorded.

Study contacts

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

Hua-Long Zheng, phD

CONTACT

[email protected]

18359190587

Mi Lin, phD

CONTACT

[email protected]

13459152658

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

Prospective Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With D2 Extra-regional Lymph Node Dissection for Locally Advanced Gastric Cancer (FUGES-30)

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Apr 25, 2025
Registry last updated
May 8, 2025

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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