Clinical trial NCT06945718: Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Extended Lymphadenectomy Beyond D2 for Locally Advanced Gastric Cancer (FUGES-30)
Official 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Surgery
Keywords: Gastric Cancer
Laparoscopic Gastrectomy
Indocyanine Green Tracer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Total number of retrieved lymph nodes
timeFrame: 30 days
measure: Noncompliance rate of lymph node dissection
timeFrame: 30 days
measure: Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
timeFrame: 30 days
measure: Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)
timeFrame: 30 days
measure: Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)
timeFrame: 30 days
measure: Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)
timeFrame: 30 days
measure: Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)
timeFrame: 30 days
measure: Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B
timeFrame: 30 days
measure: Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)
timeFrame: 30 days
measure: Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)
timeFrame: 30 days
measure: Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)
timeFrame: 30 days
measure: Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)
timeFrame: 30 days
measure: Number of metastatic lymph nodes
timeFrame: 30 days
measure: Metastasis rate of lymph nodes
timeFrame: 30 days
measure: Postoperative complications
timeFrame: 30 days
measure: Mortality rates
timeFrame: 30 days
measure: 3-year overall survival rate
timeFrame: 3 years
measure: 3-year recurrence pattern
timeFrame: 3 years
measure: Postoperative recovery course
timeFrame: 30 days
measure: The incidence of intraoperative complications
timeFrame: 30 days
measure: Inflammatory and immune response
timeFrame: 7 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-Ming Huang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: