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

Non-small Cell Lung Cancer Stage I Clinical Trial

— IMPLANE-0529  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453721
• Other study ID #: NFTS-1
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: The First Affiliated Hospital of Nanchang University
• Contact: Jian Tang, M.D., Ph.D
• Phone: +8615270901713
• Email: tangjianku[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: December 31, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer Stage I
• Segmentectomy

Intervention

Procedure:
• Indocyanine green fluorescence imaging method
Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
• Modified inflation-deflation method
Using modified inflation-deflation method to identify intersegmental plane in segmentectomy

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (10)

Lead Sponsor

Collaborator

The First Affiliated Hospital of Nanchang University

Dazhou Central Hospital, First Affiliated Hospital of Gannan Medical University, Fuzhou Pulmonary Hospital of Fujian, Guangdong Provincial People's Hospital, Ningbo Huamei Hospital, University of Chinese Academy of Sciences, Ningde Municipal Hospital of Ningde Normal University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Wuhan Union Hospital, China, Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Coincidence rate of intersegmental plane identification	The shortest distance between the nodule and the cutting edge in all directions in postoperative pathological specimens versus distances measured in preoperative 3D reconstruction in same directions	Within 14 days after surgery
Primary	Success rate of intersegmental plane identification	Successful intraoperative appearance of the intersegmental plane is considered a success	During the operation
Secondary	Intersegment plane identification time	Indocyanine green injection/start of ventilation to the first observed intersegment plane appearance	During the surgery
Secondary	Surgery time	Time from the beginning to the end of the surgery	During the surgery
Secondary	Intraoperatve blood loss	Blood loss during the surgery	During the surgery
Secondary	Postoperative blood loss	Blood loss after the surgery	Postoperative in-hospital stay up to 30 days
Secondary	Postoperative air leakage rate	Air leakage after the surgery	Postoperative in-hospital stay up to 30 days
Secondary	Postoperative air leakage time	time of air leakage after the surgery	Postoperative in-hospital stay up to 30 days
Secondary	Preoperative pulmonary function	FEV1.0(forced expiratory volume in 1.0 s)	1 week before the surgery
Secondary	Preoperative pulmonary function	FVC(forced vital capacity)	1 week before the surgery
Secondary	Postoperative pulmonary function	FEV1.0(forced expiratory volume in 1.0 s)	6/12 months after surgery
Secondary	Postoperative pulmonary function	FVC(forced vital capacity)	6/12 months after surgery
Secondary	Quality of life(EORTCQLQ-C30)	Quality of life Scale	6/12 months after surgery
Secondary	Adverse event rate	According to CTCAE-V5.0	Through study completion, an average of 2 year
Secondary	Adverse event level	According to CTCAE-V5.0	Through study completion, an average of 2 year
Secondary	Surgical complication	According to Clavien-Dindo grading system	Postoperative in-hospital stay up to 30 days
Secondary	Postoperative 30-day mortality	Deaths occurring within 30 days after surgery	Within 30 days after surgery
Secondary	Postoperative 90-day mortality	Deaths occurring within 90 days after surgery	Within 90 days after surgery
Secondary	Reoperation rate	The percentage of patients who need a second operation	Within 30 days after surgery
Secondary	Number of stapler nail bin used for cutting	Number of stapler nail bin used for cutting	During the surgery
Secondary	R0 resection rate	Negative surgical margin under the microscope	Within 14 days after surgery