RecruitingNot ApplicableNCT05453721

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


Sponsor

The First Affiliated Hospital of Nanchang University

Enrollment

272 participants

Start Date

Aug 4, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two techniques surgeons use during lung surgery to identify the boundary between different segments of the lung that need to be removed. One method uses a glowing dye (indocyanine green) viewed under special light; the other uses air inflation and deflation to visualize the boundary. The goal is to determine which method is more accurate and safer. **You may be eligible if...** - You are between 18 and 80 years old - You have a small lung tumor (up to 2 cm) in the middle or outer part of a lung lobe (not the middle lobe) - Your tumor is at an early clinical stage (cT1a-1bN0M0) - Your heart, lungs, liver, and kidneys are functioning adequately - Your ECOG performance status is 0 or 1 **You may NOT be eligible if...** - Your tumor is larger than 2 cm or in the middle lobe - You have poor lung function (predicted post-surgery FEV1 below 40% or DLCO below 40%) - You have significant heart, liver, or kidney disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIndocyanine green fluorescence imaging method

Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy

PROCEDUREModified inflation-deflation method

Using modified inflation-deflation method to identify intersegmental plane in segmentectomy


Locations(1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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NCT05453721


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