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Dye vs. air: which better guides lung cancer surgery?

NCT ID NCT05453721

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two ways for surgeons to see the borders between lung segments during surgery for early-stage non-small cell lung cancer. One method uses a green dye and a special camera, the other uses a modified inflation-deflation technique. The trial involved 272 patients across multiple centers and measured how often each method successfully showed the segment border, as well as surgery time and blood loss. The goal is to provide evidence to help surgeons choose the best approach for precise lung-sparing surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indocyanine green dye
What this could lead to
If successful, this could help surgeons choose the best method to identify lung segment boundaries, potentially improving surgery accuracy and recovery for early-stage lung cancer patients.
What could go wrong
This is a completed trial comparing two techniques, not testing a new treatment. The results may not change practice if one method is not clearly better, and findings may not apply to all patients or hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

272 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

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