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

Launched by THE FIRST AFFILIATED HOSPITAL OF NANCHANG UNIVERSITY · Jul 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to help surgeons identify the boundaries of lung tissue during a specific type of surgery called segmentectomy, which is often performed for patients with early-stage non-small cell lung cancer. The two methods being compared are the indocyanine green fluorescence imaging method and the modified inflation-deflation method. The goal is to find out which method is better at helping surgeons make precise cuts, which can lead to better outcomes for patients.

To participate in this study, you need to be between 18 and 80 years old and meet certain health criteria, like having stable blood pressure and organ functions. You should have a specific type of lung tumor that is 2 cm or smaller, located in certain parts of the lung, and have no other major health issues that would prevent you from undergoing surgery. If you join the study, you can expect to receive one of the two imaging methods during your surgery, and you'll be monitored for your recovery and any long-term effects. This research aims to provide valuable information that can help improve surgical techniques for lung cancer patients in the future.

Gender

ALL

Eligibility criteria

• 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.