NCT05453721Completed
Effect and Long-Term Outcomes of Indocyanine Green Fluorescence Imaging Method Versus Modified Inflation-Deflation Method in Identification of Intersegmental Plane(IMPLANE-0529)
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
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 272 (actual)
- First submitted
- 24 Jun 2022
- Start date
- 4 Aug 2022
- Primary completion date
- 19 Nov 2024
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Diseases
- Lung cancer
- NCT number
- NCT05453721
What you commit to
- Study type: Interventional
- Participants enrolled: 272
- From 4 Aug 2022 to the primary completion date, 19 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who had received antitumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) prior to surgery;
- Prior history of unilateral thoracotomy;
Other illness
- Patient with a history of iodine or indocyanine green allergy;
- Patient with a history of other malignancies;
- Patient with secondary primary cancer at enrollment;
- Small cell lung cancer;
- 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;
Other
- Woman in pregnant or breastfeeding period;
- Patient with interstitial pneumonia, pulmonary fibrosis or severe emphysema;
- patient that researcher considers inappropriate to participate in this study.
Who the study is looking for
- 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;
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.