NCT05453721

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: The First Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Indocyanine green fluorescence imaging method	Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
PROCEDURE	Modified inflation-deflation method	Using modified inflation-deflation method to identify intersegmental plane in segmentectomy

Timeline

• Start date: 2022-08-04
• Primary completion: 2026-07-01
• Completion: 2027-12-31
• First posted: 2022-07-12
• Last updated: 2023-09-13

Locations

1 site across 1 country: China