Effect and Long-Term Outcomes of Indocyanine Green Fluorescence Imaging Method Versus Modified In… (NCT05453721) | Clinical Trial Compass
CompletedNot Applicable
Effect and Long-Term Outcomes of Indocyanine Green Fluorescence Imaging Method Versus Modified Inflation-Deflation Method in Identification of Intersegmental Plane（IMPLANE-0529）
China272 participantsStarted 2022-08-04
Plain-language summary
This study is a multi-center, prospective, randomized controlled clinical trial. The purpose is to compare the difference of indocyanine green fluorescence imaging method and modified inflation-deflation method in identifying intersegmental plane in segmentectomy, and provide high-level evidence for the selection of intersegmental plane identification method in early NSCLC segmental resection.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 18 to 80 years old;
✓. According to the surgical standards of the Eighth edition of People's Medical Publishing House, patients whose blood pressure was under 160/100mmHg and blood glucose was under 5.6-11.2mmol /L with normal functions of major organs such as heart, lung, liver and kidney before surgery are included. The main criteria are as follows:
✓. The center of the lesion is located in the other lobes except the middle lobe, and in the middle and outer third of the lung;
✓. The maximum diameter of the tumor was not more than 2cm on TLC(Thin layer CT) scan and the clinical stage was cT1a-1bN0M0(according to AJCC staging criteria, eighth edition);
✓. Consolidation tumor rate \<1；
✓. ECOG PSscore 0-1;
✓. All relevant examinations should be completed within 28 days before surgery;
✓. Patients who understand the study and have signed informed consent.
Exclusion criteria
✕. Patient with a history of iodine or indocyanine green allergy;
✕. Patient who had received antitumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) prior to surgery;
✕. Patient with a history of other malignancies;
✕. Patient with secondary primary cancer at enrollment;
What they're measuring
1
Success rate of intersegmental plane identification
Timeframe: During the operation
Trial details
NCT IDNCT05453721
SponsorThe First Affiliated Hospital of Nanchang University