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Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

Recruiting
18-75 years
All
Phase 2

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Overview

Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.

Description

Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.

Eligibility

Inclusion Criteria:

  1. Age from 18 to 75 years
  2. Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition)
        (4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in
        the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern
        Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to
        III (7) Written informed consent
        Exclusion Criteria:
          1. Women during pregnancy or breast-feeding
          2. Severe mental disorder
          3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy
             and gastrectomy)
          4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
          5. Rejection of laparoscopic resection
          6. History of allergy to iodine agents
          7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
          8. History of other malignant disease within past five years
          9. History of previous neoadjuvant chemotherapy or radiotherapy
         10. History of unstable angina or myocardial infarction within the past six months
         11. History of unstable angina or myocardial infarction within past six months
         12. History of continuous systematic administration of corticosteroids within one month
         13. Requirement of simultaneous surgery for another disease
         14. Emergency surgery due to complications (bleeding, obstruction or perforation) caused
             by gastric cancer
         15. FEV1<50% of the predicted values
         16. Linitis plastica, Widespread

Study details
    Gastric Cancer

NCT05618821

Fujian Medical University

27 January 2024

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