Effect and Long-Term Outcomes of Indocyanine Green Fluorescence Imaging Method Versus Modified Inflation-Deflation Method in Identification of Intersegmental Plane（IMPLANE-0529）
Effect and Long-Term Outcomes of Indocyanine Green Fluorescence Imaging Method Versus Modified Inflation-Deflation Method in Identification of Intersegmental Plane: A Multicenter、Prospective、Randomized Controlled Trial
The First Affiliated Hospital of Nanchang University
272 participants
Aug 4, 2022
INTERVENTIONAL
Conditions
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 Criteria9
- 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:
- 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;
- 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 Criteria12
- 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;
- Small cell lung cancer;
- Prior history of unilateral thoracotomy;
- Woman in pregnant or breastfeeding period;
- Patient with interstitial pneumonia, pulmonary fibrosis or severe emphysema;
- An active bacterial or fungal infection that is difficult to control;
- Severe mental illness;
- History of severe heart disease , heart failure , myocardial infarction or angina pectoris within the last 6 months;
- patient that researcher considers inappropriate to participate in this study.
Interventions
Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
Using modified inflation-deflation method to identify intersegmental plane in segmentectomy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05453721