Clinical trial NCT05453721: Effect and Long-Term Outcomes of Indocyanine Green Fluorescence Imaging Method Versus Modified Inflation-Deflation Method in Identification of Intersegmental Plane（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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Segmentectomy
Non-small Cell Lung Cancer Stage I
Keywords: Segmentectomy
Intersegmental plane identification
Indocyanine green fluorescence imaging method
Modified inflation-deflation method
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
name: Dazhou Central Hospital
name: Ningde Municipal Hospital of Ningde Normal University
name: First Affiliated Hospital of Gannan Medical University
name: Fuzhou Pulmonary Hospital of Fujian
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Ningbo No.2 Hospital
name: Guangdong Provincial People's Hospital
name: Zhejiang Provincial People's Hospital
First posted: 2022-07-12
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Success rate of intersegmental plane identification
timeFrame: During the operation
Secondary outcomes:
measure: Intersegment plane identification time
timeFrame: During the surgery
measure: Surgery time
timeFrame: During the surgery
measure: Intraoperatve blood loss
timeFrame: During the surgery
measure: Postoperative blood loss
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Postoperative air leakage rate
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Postoperative air leakage time
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Preoperative pulmonary function
timeFrame: 1 week before the surgery
measure: Preoperative pulmonary function
timeFrame: 1 week before the surgery
measure: Postoperative pulmonary function
timeFrame: 6/12 months after surgery
measure: Postoperative pulmonary function
timeFrame: 6/12 months after surgery
measure: Quality of life（EORTCQLQ-C30)
timeFrame: 6/12 months after surgery
measure: Adverse event rate
timeFrame: Through study completion, an average of 2 year
measure: Adverse event level
timeFrame: Through study completion, an average of 2 year
measure: Surgical complication
timeFrame: Postoperative in-hospital stay up to 30 days
measure: Postoperative 30-day mortality
timeFrame: Within 30 days after surgery
measure: Postoperative 90-day mortality
timeFrame: Within 90 days after surgery
measure: Reoperation rate
timeFrame: Within 30 days after surgery
measure: Number of stapler nail bin used for cutting
timeFrame: During the surgery
measure: R0 resection rate
timeFrame: Within 14 days after surgery
Other outcomes:
measure: Coincidence rate of intersegmental plane identification
timeFrame: Within 14 days after surgery
Locations:
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: The First Affiliated Hospital of Nanchang University
name: Jian Tang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: