An interventional study of Indocyanine green fluorescence imaging method and Modified inflation-deflation method in Segmentectomy and Non-small Cell Lung Cancer Stage I, sponsored by The First Affiliated Hospital of Nanchang University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by The First Affiliated Hospital of Nanchang University · Not applicable, Interventional, and Treatment
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 272 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →The First Affiliated Hospital of Nanchang University is the lead sponsor of 26 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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;
Exclusion Criteria:
Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
Procedure: Indocyanine green fluorescence imaging method
Using modified inflation-deflation method to identify intersegmental plane in segmentectomy
Procedure: Modified inflation-deflation method
Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
Using modified inflation-deflation method to identify intersegmental plane in segmentectomy
Success rate of intersegmental plane identification
Successful intraoperative appearance of the intersegmental plane is considered a success
Time frame: During the operation
Intersegment plane identification time
Indocyanine green injection/start of ventilation to the first observed intersegment plane appearance
Time frame: During the surgery
Surgery time
Time from the beginning to the end of the surgery
Time frame: During the surgery
Intraoperatve blood loss
Blood loss during the surgery
Time frame: During the surgery
Postoperative blood loss
Blood loss after the surgery
Time frame: Postoperative in-hospital stay up to 30 days
Postoperative air leakage rate
Air leakage after the surgery
Time frame: Postoperative in-hospital stay up to 30 days
Postoperative air leakage time
time of air leakage after the surgery
Time frame: Postoperative in-hospital stay up to 30 days
Preoperative pulmonary function
FEV1.0(forced expiratory volume in 1.0 s)
Time frame: 1 week before the surgery
Preoperative pulmonary function
FVC(forced vital capacity)
Time frame: 1 week before the surgery
Postoperative pulmonary function
FEV1.0(forced expiratory volume in 1.0 s)
Time frame: 6/12 months after surgery
Postoperative pulmonary function
FVC(forced vital capacity)
Time frame: 6/12 months after surgery
Quality of life（EORTCQLQ-C30)
Quality of life Scale
Time frame: 6/12 months after surgery
Adverse event rate
According to CTCAE-V5.0
Time frame: Through study completion, an average of 2 year
Adverse event level
According to CTCAE-V5.0
Time frame: Through study completion, an average of 2 year
Surgical complication
According to Clavien-Dindo grading system
Time frame: Postoperative in-hospital stay up to 30 days
Postoperative 30-day mortality
Deaths occurring within 30 days after surgery
Time frame: Within 30 days after surgery
Postoperative 90-day mortality
Deaths occurring within 90 days after surgery
Time frame: Within 90 days after surgery
Reoperation rate
The percentage of patients who need a second operation
Time frame: Within 30 days after surgery
Number of stapler nail bin used for cutting
Number of stapler nail bin used for cutting
Time frame: During the surgery
R0 resection rate
Negative surgical margin under the microscope
Time frame: Within 14 days after surgery
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
Time frame: Within 14 days after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung→
The First Affiliated Hospital of Nanchang University