Effect and Long-Term Outcomes of Indocyanine Green Fluorescence Imaging Method Versus Modified Inflation-Deflation Method in Identification of Intersegmental Plane（IMPLANE-0529）

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.

Eligibility

Inclusion Criteria:

1. Aged 18 to 80 years old;
2. 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:

   i. Cardiac function examination indicated Goldman index grade 1-2; ii. Pulmonary function examination suggested postoperative predicted FEV1≥40% and DLCO≥40%; iii. Total bilirubin ≤1.5 times the upper limit of normal; iv. Alanine aminotransferase and aspartate aminotransferase ≤2.5 times the upper limit of normal value; v. Creatinine ≤1.25 times the upper limit of normal value and creatinine clearance ≥60ml/min;
3. 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;
4. 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);
5. Consolidation tumor rate \<1；
6. ECOG PSscore 0-1;
7. All relevant examinations should be completed within 28 days before surgery;
8. Patients who understand the study and have signed informed consent.

Exclusion Criteria:

1. Patient with a history of iodine or indocyanine green allergy;
2. Patient who had received antitumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) prior to surgery;
3. Patient with a history of other malignancies;
4. Patient with secondary primary cancer at enrollment;
5. Small cell lung cancer;
6. Prior history of unilateral thoracotomy;
7. Woman in pregnant or breastfeeding period;
8. Patient with interstitial pneumonia, pulmonary fibrosis or severe emphysema;
9. An active bacterial or fungal infection that is difficult to control;
10. Severe mental illness;
11. History of severe heart disease , heart failure , myocardial infarction or angina pectoris within the last 6 months;
12. patient that researcher considers inappropriate to participate in this study.

Conditions4

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