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Recruiting NCT05618821

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

Conditions: Gastric Cancer

Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE2
Enrollment: 68
Sponsor: Fujian Medical University

Location: China

Summary

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.

Eligibility Criteria

Inclusion Criteria:Age from 18 to 75 yearsRemnant 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 consentExclusion Criteria:Women during pregnancy or breast-feedingSevere mental disorderHistory of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)History of previous gastric surgery (including ESD/EMR for gastric cancer)Rejection of laparoscopic resectionHistory of allergy to iodine agentsEnlarged or bulky regional lymph node diameter over 3cm by preoperative imagingHistory of other malignant disease within past five yearsHistory of previous neoadjuvant chemotherapy or radiotherapyHistory of unstable angina or myocardial infarction within the past six monthsHistory of unstable angina or myocardial infarction within past six monthsHistory of continuous systematic administration of corticosteroids within one monthRequirement of simultaneous surgery for another diseaseEmergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancerFEV1<50% of the predicted valuesLinitis plastica, Widespread

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05618821). StuddyBuddy aggregates publicly available trial information.