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

NCT05453721 | Completed

• 1 other identifier: NFTS-1
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Segmentectomy; Non-small Cell Lung Cancer Stage I

Keywords

Segmentectomy; Intersegmental plane identification; Indocyanine green fluorescence imaging method; Modified inflation-deflation method

Outcome Measures

Primary Outcomes (1)

• Success rate of intersegmental plane identification

  Successful intraoperative appearance of the intersegmental plane is considered a success

  During the operation

Secondary Outcomes (19)

• Intersegment plane identification time

  During the surgery

• Surgery time

  During the surgery

• Intraoperatve blood loss

  During the surgery

• Postoperative blood loss

  Postoperative in-hospital stay up to 30 days

• Postoperative air leakage rate

  Postoperative in-hospital stay up to 30 days

Other Outcomes (1)

• Coincidence rate of intersegmental plane identification

  Within 14 days after surgery

Study Arms (2)

Indocyanine green fluorescence imaging method group

EXPERIMENTAL

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

Procedure: Indocyanine green fluorescence imaging method

Modified inflation-deflation method group

ACTIVE COMPARATOR

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

Procedure: Modified inflation-deflation method

Interventions

Modified inflation-deflation method PROCEDURE

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

Modified inflation-deflation method group

Indocyanine green fluorescence imaging method PROCEDURE

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

Indocyanine green fluorescence imaging method group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Dazhou Central Hospital: collaborator
• Ningde Municipal Hospital of Ningde Normal University: collaborator
• First Affiliated Hospital of Gannan Medical University: collaborator
• Fuzhou Pulmonary Hospital of Fujian: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Ningbo No.2 Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jian Tang, M.D., Ph.D

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D, Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 12, 2022
• Study Start: August 4, 2022
• Primary Completion: November 19, 2024
• Study Completion: December 20, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)