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

Not Applicable

Recruiting

• Conditions: Segmentectomy; Non-small Cell Lung Cancer Stage I
• Interventions: Procedure: Indocyanine green fluorescence imaging method; Procedure: Modified inflation-deflation method

• Registration Number: NCT05453721
• Lead Sponsor: The First Affiliated Hospital of Nanchang University

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.

Study Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-08-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2026-07-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 272

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indocyanine green fluorescence imaging method group	Indocyanine green fluorescence imaging method	Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
Modified inflation-deflation method group	Modified inflation-deflation method	Using modified inflation-deflation method to identify intersegmental plane in segmentectomy

Primary Outcome Measures

Name	Time	Method
Success rate of intersegmental plane identification	During the operation	Successful intraoperative appearance of the intersegmental plane is considered a success

Secondary Outcome Measures

Name	Time	Method
Postoperative air leakage rate	Postoperative in-hospital stay up to 30 days	Air leakage after the surgery
Preoperative pulmonary function	1 week before the surgery	FVC(forced vital capacity)
Postoperative pulmonary function	6/12 months after surgery	FVC(forced vital capacity)
Quality of life（EORTCQLQ-C30)	6/12 months after surgery	Quality of life Scale
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 30-day mortality	Within 30 days after surgery	Deaths occurring within 30 days after surgery
Postoperative air leakage time	Postoperative in-hospital stay up to 30 days	time of air leakage after the surgery
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 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

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China