SegmentectomyIMPLANE-0529NCT05453721

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

A study testing Indocyanine green fluorescence imaging method and Modified inflation-deflation method in people with Segmentectomy and Non-small Cell Lung Cancer Stage I, run by The First Affiliated Hospital of Nanchang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Segmentectomy, Non-small Cell Lung Cancer Stage I
What is being tested?: Indocyanine green fluorescence imaging method and Modified inflation-deflation method
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 272 participants
Where: 1 siteChina
Study dates: 4 Aug 2022to 20 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18 to 80 years old;
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:
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;
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;
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);
Consolidation tumor rate <1；

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ECOG PSscore 0-1;
All relevant examinations should be completed within 28 days before surgery;
Patients who understand the study and have signed informed consent.

Who cannot join

Patient with a history of iodine or indocyanine green allergy;
Patient who had received antitumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) prior to surgery;
Patient with a history of other malignancies;
Patient with secondary primary cancer at enrollment;
Small cell lung cancer;
Prior history of unilateral thoracotomy;

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Woman in pregnant or breastfeeding period;
Patient with interstitial pneumonia, pulmonary fibrosis or severe emphysema;
An active bacterial or fungal infection that is difficult to control;
Severe mental illness;
History of severe heart disease , heart failure , myocardial infarction or angina pectoris within the last 6 months;
patient that researcher considers inappropriate to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006

Other trials in China

About this study

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

Read the 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.

Conditions: Segmentectomy, Non-small Cell Lung Cancer Stage I
Being tested: Indocyanine green fluorescence imaging method, Modified inflation-deflation method
Keywords: Segmentectomy, Intersegmental plane identification, Indocyanine green fluorescence imaging method, Modified inflation-deflation method
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Indocyanine green fluorescence imaging methodProcedure or surgery
Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
Modified inflation-deflation methodProcedure or surgery
Using modified inflation-deflation method to identify intersegmental plane in segmentectomy

Study groups in NCT05453721
Study group	Role	What they receive
Indocyanine green fluorescence imaging method group	Experimental	Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy Receives: Procedure: Indocyanine green fluorescence imaging method
Modified inflation-deflation method group	Active comparator	Using modified inflation-deflation method to identify intersegmental plane in segmentectomy Receives: Procedure: Modified inflation-deflation method

What is being measured

The primary outcome is the main question the study is designed to answer.

Success rate of intersegmental plane identification
Successful intraoperative appearance of the intersegmental plane is considered a success
Measured: During the operation

Secondary outcomes (19)

Intersegment plane identification time
Indocyanine green injection/start of ventilation to the first observed intersegment plane appearance
Measured: During the surgery
Surgery time
Time from the beginning to the end of the surgery
Measured: During the surgery
Intraoperatve blood loss
Blood loss during the surgery
Measured: During the surgery
Postoperative blood loss
Blood loss after the surgery
Measured: Postoperative in-hospital stay up to 30 days
Postoperative air leakage rate
Air leakage after the surgery
Measured: Postoperative in-hospital stay up to 30 days
Postoperative air leakage time
time of air leakage after the surgery
Measured: Postoperative in-hospital stay up to 30 days
Preoperative pulmonary function
FEV1.0(forced expiratory volume in 1.0 s)
Measured: 1 week before the surgery
Preoperative pulmonary function
FVC(forced vital capacity)
Measured: 1 week before the surgery
Postoperative pulmonary function
FEV1.0(forced expiratory volume in 1.0 s)
Measured: 6/12 months after surgery
Postoperative pulmonary function
FVC(forced vital capacity)
Measured: 6/12 months after surgery
Quality of life（EORTCQLQ-C30)
Quality of life Scale
Measured: 6/12 months after surgery
Adverse event rate
According to CTCAE-V5.0
Measured: Through study completion, an average of 2 year
Adverse event level
According to CTCAE-V5.0
Measured: Through study completion, an average of 2 year
Surgical complication
According to Clavien-Dindo grading system
Measured: Postoperative in-hospital stay up to 30 days
Postoperative 30-day mortality
Deaths occurring within 30 days after surgery
Measured: Within 30 days after surgery
Postoperative 90-day mortality
Deaths occurring within 90 days after surgery
Measured: Within 90 days after surgery
Reoperation rate
The percentage of patients who need a second operation
Measured: Within 30 days after surgery
Number of stapler nail bin used for cutting
Number of stapler nail bin used for cutting
Measured: During the surgery
R0 resection rate
Negative surgical margin under the microscope
Measured: Within 14 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202220 Dec 2025

First posted12 Jul 2022
Study start4 Aug 2022
Primary completion19 Nov 2024
Study completion20 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SegmentectomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05453721
Sponsor's protocol ID: NFTS-1
Acronym: IMPLANE-0529
Status last verified: May 2026
First submitted: 24 Jun 2022
Last updated: 7 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Segmentectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05453721
Acronym / sponsor ID: IMPLANE-0529 / NFTS-1
Conditions: Segmentectomy, Non-small Cell Lung Cancer Stage I
Keywords: Segmentectomy, Intersegmental plane identification, Indocyanine green fluorescence imaging method, Modified inflation-deflation method
Study type: Interventional
Recruitment status: Completed
Enrolment: 272 participants (actual)
Lead sponsor: The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
Collaborators: 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 start: 4 Aug 2022 (actual)
Primary completion: 19 Nov 2024 (actual)
Study completion: 20 Dec 2025 (actual)
First posted: 12 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Segmentectomy is based on accurate anatomy, and the identification of intersegmental plane is one of the keys to accurate anatomy of segmentectomy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Indocyanine green fluorescence imaging method group	Experimental	Procedure: Indocyanine green fluorescence imaging methodUsing indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
Modified inflation-deflation method group	Active comparator	Procedure: Modified inflation-deflation methodUsing modified inflation-deflation method to identify intersegmental plane in segmentectomy

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Aged 18 to 80 years old;
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:
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;
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);
Consolidation tumor rate <1；

Key exclusion criteria (12 listed)

Patient with a history of iodine or indocyanine green allergy;
Patient who had received antitumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) prior to surgery;
Patient with a history of other malignancies;
Patient with secondary primary cancer at enrollment;
Small cell lung cancer;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Indocyanine green fluorescence imaging methodUsing indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy	Procedure or surgery	Indocyanine green fluorescence imaging method group
Modified inflation-deflation methodUsing modified inflation-deflation method to identify intersegmental plane in segmentectomy	Procedure or surgery	Modified inflation-deflation method group

Primary outcome

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

19 secondary outcomes

Intersegment plane identification time
Time frame: During the surgery
Surgery time
Time frame: During the surgery
Intraoperatve blood loss
Time frame: During the surgery
Postoperative blood loss
Time frame: Postoperative in-hospital stay up to 30 days
Postoperative air leakage rate
Time frame: Postoperative in-hospital stay up to 30 days
Postoperative air leakage time
Time frame: Postoperative in-hospital stay up to 30 days
Preoperative pulmonary function
Time frame: 1 week before the surgery
Preoperative pulmonary function
Time frame: 1 week before the surgery
Postoperative pulmonary function
Time frame: 6/12 months after surgery
Postoperative pulmonary function
Time frame: 6/12 months after surgery
Quality of life（EORTCQLQ-C30)
Time frame: 6/12 months after surgery
Adverse event rate
Time frame: Through study completion, an average of 2 year
Adverse event level
Time frame: Through study completion, an average of 2 year
Surgical complication
Time frame: Postoperative in-hospital stay up to 30 days
Postoperative 30-day mortality
Time frame: Within 30 days after surgery
Postoperative 90-day mortality
Time frame: Within 90 days after surgery
Reoperation rate
Time frame: Within 30 days after surgery
Number of stapler nail bin used for cutting
Time frame: During the surgery
R0 resection rate
Time frame: Within 14 days after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jian Tang, M.D., Ph.D principal investigator

The First Affiliated Hospital of Nanchang University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of intersegmental plane identification (time frame: During the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05453721.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.