Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Segmentectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green fluorescence imaging method | Procedure | — | UNRESOLVED |
| Modified inflation-deflation method | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Indocyanine green fluorescence imaging method group
- description
- Using indocyanine green fluorescence imaging method to identify intersegmental plane in segmentectomy
- interventionNames
- Procedure: Indocyanine green fluorescence imaging method
- type
- ACTIVE_COMPARATOR
- label
- Modified inflation-deflation method group
- description
- Using modified inflation-deflation method to identify intersegmental plane in segmentectomy
- interventionNames
- Procedure: Modified inflation-deflation method
Primary outcomes (1)
- measure
- Success rate of intersegmental plane identification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available