Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen.

After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide.

During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. Improved inflation-deflation method is currently the most widely used method in clinical practice. After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

100% oxygen

During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

Carbon dioxide

With the increasing acceptance of routine computed tomography (CT) screenings, early-stage lung cancer detection is becoming more frequent. For ground glass opacity predominant early-stage lung cancer, segmentectomy can get the same oncological benefits as lobectomy. In addition, lung nodules that are highly suspected to be metastases can also be performed by segmentectomy to preserve more lung function. During the surgery, the rapid and precise identification of the intersegmental plane is one of the challenges. The improved inflation-deflation method is currently the most widely used method in clinical practice. According to the dispersion coefficient of the gas, the rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. The purpose of this study was to investigate the feasibility and safety of carbon dioxide on the appearance time of satisfactory and ideal planes during segmentectomy.

This study was approved by the ethics committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. This randomized parallel group trial enrolled patients scheduled to receive thoracoscopic anatomic segmentectomy at Tongji Hospital. General anesthesia with double lumen endotracheal tube was administered to the patients. With the guidance of preoperative three-dimensional computed tomography bronchography and angiography, the targeted segment structures could be precisely dissected, and then intersegmental demarcation was confirmed by the modified inflation-deflation method in this study. In group A (100% oxygen), after dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. In group B (Carbon dioxide), after the targeted segment structures were successfully dissected, the collapsed operative lung was completely re-expanded with carbon dioxide. The purpose of this study was to investigate the feasibility and safety of carbon dioxide on the appearance time of satisfactory and ideal planes during segmentectomy. The starting time point of the intersegmental plane was when the whole lungs had completely re-expanded. The end point was when the preserved segment was fully deflated, and a boundary had formed between the targeted segment and the reserved lung.

Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy

Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy: A Randomized Controlled Study

Duration of hospitalization after surgery.

Measured using the Quality of Recovery 40 (QoR-40) Score and asking patients to complete the questions 24 hours before operation, 48 hours after operation and 1 week after operation.

The starting time point of the intersegmental plane was when the whole lungs had completely re-expanded. The end point was when the preserved segment was fully deflated, and a boundary had formed between the targeted segment and the reserved lung.

Tongji Hospital

Professor

After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen.

100% oxygen: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. Improved inflation-deflation method is currently the most widely used method in clinical practice. After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

Group A: 100% Oxygen

After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide.

Carbon dioxide: During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

Group B: Carbon Dioxide

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

China

Region of Enrollment

body mass index (BMI)

Dr. Wei Ping

The Intersegmental Border Appearance Time During the Surgery.

The Arterial Blood Gas Results During Perioperative Period.

The Incidence of Postoperative Complications.

The Length of Hospital Stays.

Quality of Recovery.

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Hyperspectral Imaging Intersegmental plane identification:

Defined as distance between intersegmental plane identification with Hyperspectral Imaging compared to near-infrared indocyanine green fluorescence.

Identification of the intersegmental plane

Hyperspectral Imaging

David B Ellebrecht, MD

The purpose of this study is the identification of the intersegmental plane and navigation during sublobar pulmonary resections in lung cancer using Hyperspectral Imaging, the comparison with ICG fluorescence intersegmental plane identification, and the establishment of automatic intersegmental plane navigation using machine learning strategies for intraoperative navigation.

Lung cancer is the leading cause of cancer-related death worldwide. Due to the generalization of screening strategies, especially for risk populations, an increasing number of lung cancer cases are detected in an early stage. In this regard, lung cancer is also increasingly diagnosed in patients with impaired pulmonary function. For preserving lung function and reducing complication incidence, pulmonary segmentectomies are currently evaluated in this cohort. Thus, the latest version of the German guideline for the prevention, diagnosis, treatment and follow-up of lung cancer recommends segmentectomy for patients with impaired pulmonary function in tumor stage I/II. However, the identification of the intersegmental plane - the key step of segmentectomy - remains challenging. Inaccurate recognition of the intersegmental plane may lead to dysfunction of the remaining lung tissue, mismatching of ventilation or blood flow, or long-term air leakage after surgery, which even requires unplanned secondary surgery. Indocyanine green (ICG) is one the latest evaluated identification methods and is considered as gold standard. Hyperspectral Imaging (HSI) - a newly established intraoperative imaging technique - enables a non-invasive evaluation of tissue perfusion and the discrimination of pulmonary tissue with different tissue perfusion during segmentectomies.

The purpose of this prospective, single-center, non-inferiority IDEAL Stage 2b study is the identification of the intersegmental plane and navigation during sublobar pulmonary resections in lung cancer using Hyperspectral Imaging, the comparison with ICG fluorescence intersegmental plane identification, and the establishment of automatic intersegmental plane navigation using machine learning strategies for intraoperative navigation.

To address this, the intersegmental plane will be detected by both HSI and ICG-fluorescence during pulmonary segmentectomies and the correspondence of the two identification methods will be compared with one another. Using machine learning strategies, the detection of perfused and non-perfused pulmonary tissue and intersegmental plane will be analyzed. Finally, the investigators will study motion tracking for the improvement of future HSI illustrations during surgery.

The hypothesis of this study is that HSI could improve the intraoperative navigation during pulmonary segmentectomies providing as reliable intersegmental plane identification as the gold standard of indocyanine green fluorescence. In this case, an intravenous application of fluorescent dye would not be required anymore for the intersegmental plane identification.

In the case of complex segment resection, a large amount or repeated use of ICG is necessary due to its short pulmonary circulation time. Multiple use of ICG may result in ICG entering the target lung tissue through the bronchial circulation and increases the risk of adverse drug reactions of ICG. In contrast, the advantages of HSI would be a faster and repetitive measurement during surgery. There will be a potential for reducing the total measurement time during intersegmental plane dissection (10 seconds vs. 3 minutes / measurement) and consequently patient's burden. In this context, several studies of HSI-based perfusion measurement during esophageal or colorectal surgery showed already an improved patients' outcome. Furthermore, HSI can be used for surgery on patients with hyperthyroidism or impaired renal or hepatic function.

In order to support this hypothesis, a prospective non-inferiority trial design will be used in this study. To ensure the quality of data acquisition and reporting, the study will be conducted in accordance with the IDEAL reporting guidelines. During pulmonary segmentectomies, the intersegmental plane will be identified by both HSI and ICG fluorescence. The determined HSI intersegmental margin will be benchmarked against the ground truth ICG fluorescence and the feasibility and reproducibility of HSI and ICG mapping will be studied.

Machine learning methods have greatly improved the interpretation of subtle patterns in medical image data. Convolutional neural networks (CNNs) can be considered state-of-the-art for classification and segmentation of medical images. The investigators will extend CNN-based methods for HSI classification and particularly study patch-based differentiation between perfused and non-perfused tissue using ICG and HSI data acquired at the same position. A further challenge is the relatively slow acquisition of HSI (10 seconds/measurement), which makes it prone to motion artifacts, e.g., due to pulsatile motion. To address this, the investigators will study motion tracking, which is also relevant for the future illustration of the segment boundary during surgery.

Machine learning approaches and particularly CNNs allow to directly optimize classifiers based on actual clinical data and the spectral dimension can be handled in a straightforward fashion. Moreover, as a versatile method for image processing, CNNs can also be used for localization and motion compensation during intraoperative imaging, e.g., they can be trained to detect image features and their motion in red/green/blue image streams. This is interesting for the proposed HSI data acquisition, which is based on a sequence of measurements which are sensitive to tissue motion.

HSI for Intersegmental Plane Identification During Sublobar Pulmonary Resections

Hyperspectral Imaging for Intersegmental Plane Identification During Sublobar Pulmonary Resections in Lung Cancer Patients

Intersegmental plane identification with machine learning strategies. To predicted intersegmental plane by the machine learning algorithm developed in this project. The machine learning algorithm is trained on thoracoscopic HSI image and specimen data to predict if the intersegmental plane is displayed correctly during surgery.

Safety will be evaluated by measuring the rates of adverse reactions to HSI and ICG dye, intraoperative complications, and perioperative complications using the Ottawa Thoracic Morbidity and Mortality Classification

Distance between intersegmental plane identification with Hyperspectral Imaging compared to near-infrared indocyanine green fluorescence

Shortest distance between tumor and HSI and ICG-fluorescence predicted intersegmental plane

Evaluation of feasibility of HSI and ICG-fluorescence intersegmental plane identification using a 7-item binary rating scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy	NCT05350137	Lung Cancer Pulmonary Nodul... Segmentectomy Pulmonary Nodul...	100% oxygen Carbon dioxide	18 Years - 80 Years	Tongji Hospital
HSI for Intersegmental Plane Identification During Sublobar Pulmonary Resections	NCT05676788	Lung Neoplasm Pulmonary Metas...	Hyperspectral I...	18 Years -	LungenClinic Grosshansdorf

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