Comparing two methods for identifying lung segment boundaries in cancer surgery

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

This study is testing two different ways to find the boundaries of lung segments during surgery for early-stage lung cancer to see which method works better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 272 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Nanchang University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT05453721 on ClinicalTrials.gov

What this trial studies

This multi-center, prospective, randomized controlled clinical trial aims to compare the effectiveness of the indocyanine green fluorescence imaging method versus the modified inflation-deflation method for identifying intersegmental planes during segmentectomy in patients with early-stage non-small cell lung cancer (NSCLC). The study will enroll 272 patients with peripheral stage I NSCLC, randomly assigning them to either the experimental or control group. By evaluating the outcomes of both methods, the trial seeks to provide high-level evidence to guide the selection of the best technique for segmental resection in lung cancer surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with peripheral stage I NSCLC tumors measuring 2cm or less.

Not a fit: Patients with tumors located in the middle lobe or those with significant comorbidities affecting surgical eligibility may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and quality of life for patients undergoing segmentectomy for early-stage lung cancer.

How similar studies have performed: While there is ongoing debate regarding the best method for intersegmental plane identification, this study's approach is novel and aims to fill a gap in the current clinical consensus.

Eligibility criteria

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.

Where this trial is running

Nanchang, Jiangxi

• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Principal investigator: Jian Tang, M.D., Ph.D — The First Affiliated Hospital of Nanchang University
• Study coordinator: Jian Tang, M.D., Ph.D

Conditions Segmentectomy; Non-small Cell Lung Cancer Stage I; Intersegmental plane identification; Indocyanine green fluorescence imaging method; Modified inflation-deflation method