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Recruiting NCT06945718

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

— Observational Gastric Cancer Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: beyond D2 regional lymph node dissection.
Who it may be relevant to
Registry conditions: Gastric Cancer, Surgery. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • Procedure beyond D2 regional lymph node dissection
    dissect the lymph nodes outside the extent of D2 LN region.

Primary outcome measures

  • 3-year disease free survival rate [Time frame: 3 years]
Secondary outcome measures (12)
  • Total number of retrieved lymph nodes [Time frame: 30 days]
  • Noncompliance rate of lymph node dissection [Time frame: 30 days]
  • Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A [Time frame: 30 days]
  • Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate) [Time frame: 30 days]
  • Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate) [Time frame: 30 days]
  • Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate) [Time frame: 30 days]
  • Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate) [Time frame: 30 days]
  • Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B [Time frame: 30 days]
  • Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate) [Time frame: 30 days]
  • Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate) [Time frame: 30 days]
  • Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate) [Time frame: 30 days]
  • Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate) [Time frame: 30 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fujian Medical University Union Hospital — Fuzhou

Identifiers

NCT: NCT06945718 · FUGES-30

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗