Non-small Cell Lung Cancer Stage I, Segmentectomy
Conditions
Keywords
Segmentectomy, Intersegmental plane identification, Indocyanine green fluorescence imaging method, Modified inflation-deflation method
Brief 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.
Detailed description
In patients with early-stage lung cancer, segmentectomy has comparable long-term survival results compared with conventional lobectomy, but patients have a higher postoperative quality of life because more lung tissue is preserved. Segmentectomy is based on accurate anatomy, and the identification of intersegmental plane is one of the keys to accurate anatomy of segmentectomy. At present, differential ventilation and differential colorimetry are clinically used to cause the difference between the target segment and the adjacent lung segment to identify intersegmental plane, which both have advantages and disadvantages. Clinical consensus on the best method for intersegmental plane identification has not been formed. This study is a multi-center, prospective, randomized controlled clinical trial. The study plans to enroll 272 patients with peripheral stage I NSCLC with tumor diameter ≤2cm and consolidation tumor rate \<1. Eligible patients will be randomly divided into the experimental group (indocyanine green fluorescence imaging method) or control group (modified inflation-deflation method) at a ratio of 1:1. This study is expected 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 segmentectomy.
Interventions
PROCEDUREIndocyanine green fluorescence imaging method
Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
PROCEDUREModified inflation-deflation method
Using modified inflation-deflation method to identify intersegmental plane in segmentectomy
Sponsors
The First Affiliated Hospital of Nanchang University
Dazhou Central Hospital
Ningde Municipal Hospital of Ningde Normal University
First Affiliated Hospital of Gannan Medical University
Fuzhou Pulmonary Hospital of Fujian
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Ningbo No.2 Hospital
Guangdong Provincial People's Hospital
Zhejiang Provincial People's Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study has two parallel arms, Indocyanine green fluorescence imaging method (treatment arm) and Modified inflation-deflation method (control arm) are included in this study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of intersegmental plane identification | During the operation | Successful intraoperative appearance of the intersegmental plane is considered a success |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intersegment plane identification time | During the surgery | Indocyanine green injection/start of ventilation to the first observed intersegment plane appearance |
| Surgery time | During the surgery | Time from the beginning to the end of the surgery |
| Intraoperatve blood loss | During the surgery | Blood loss during the surgery |
| Postoperative blood loss | Postoperative in-hospital stay up to 30 days | Blood loss after the surgery |
| Postoperative air leakage rate | Postoperative in-hospital stay up to 30 days | Air leakage after the surgery |
| Postoperative air leakage time | Postoperative in-hospital stay up to 30 days | time of air leakage after the surgery |
| Preoperative pulmonary function | 1 week before the surgery | FEV1.0(forced expiratory volume in 1.0 s) |
| Postoperative pulmonary function | 6/12 months after surgery | FEV1.0(forced expiratory volume in 1.0 s) |
| Quality of life（EORTCQLQ-C30) | 6/12 months after surgery | Quality of life Scale |
| Adverse event rate | Through study completion, an average of 2 year | According to CTCAE-V5.0 |
| Adverse event level | Through study completion, an average of 2 year | According to CTCAE-V5.0 |
| Surgical complication | Postoperative in-hospital stay up to 30 days | According to Clavien-Dindo grading system |
| Postoperative 30-day mortality | Within 30 days after surgery | Deaths occurring within 30 days after surgery |
| Postoperative 90-day mortality | Within 90 days after surgery | Deaths occurring within 90 days after surgery |
| Reoperation rate | Within 30 days after surgery | The percentage of patients who need a second operation |
| Number of stapler nail bin used for cutting | During the surgery | Number of stapler nail bin used for cutting |
| R0 resection rate | Within 14 days after surgery | Negative surgical margin under the microscope |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJian Tang, M.D., Ph.D
The First Affiliated Hospital of Nanchang University
Outcome results
None listed