Clinical trial NCT04211051: Safety and Feasibility of Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules
Official title: Safety and Feasibility of a Novel Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Keywords: lung neoplasm
localization of lung nodules
ground glass opacity
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Futuo Zhida Medical Technology Co., Ltd
First posted: 2019-12-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. The result of our early animal experiments show that the pulmonary surgery marker system can deliver the intraoperative localization safely and precisely under anesthesia, and the average distance between the localization and the simulated lesion is less than 5mm during surgery. Therefore, the safety and feasibility of the system require further evaluation in patients

Detailed description: This is a prospective, single-center clinical trial initiated by the investigator. LungBrella marker can be accurately implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery. The study is expected to enroll 10 patients. Finally, the effectiveness and safety of the method will be evaluated. This method not only can complete pulmonary nodule localization in the operating room without occupying the resources of radiology department, but also can let patients receive pulmonary nodule location after anesthesia. Thereby the risks during transportation are avoided and the suffering of patients is reduced.

Eligibility criteria: Inclusion Criteria:

Subjects should meet all of the following criteria

* diagnosis of pulmonary nodule, single nodule operation to be performed and nodule to be located by the decision of chief surgeon.
* commit to follow the research procedures and cooperate with the implementation of the whole process research
* 1 / 3 of pulmonary nodules are located in the periphery of the lung
* signed informed consent with date

Exclusion Criteria:

* the target lesion is close to the hilar or large blood vessels
* subjects with FEV1 less than 1.2 in lung function
* subjects with cardiac function III and cardiac function IV (NYHA, New York)
* subjects with uncontrollable acute pleura infection
* patients with previous history of thoracic surgery (thoracotomy), plural infection, and plural thickening and adhesion on the affected side
* Other factors that investigators disagree enrollment.

Primary outcomes:
measure: Positioning success rate
timeFrame: Immediately after resection
Secondary outcomes:
measure: Procedure time
timeFrame: Duration of procedure
measure: Complications
timeFrame: One month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RuijinhospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine
name: Hecheng Li, MD&PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Hecheng Li, MD&PHD
role: STUDY_CHAIR
References:
citation: Li C, Zheng Y, Yuan Y, Li H. Augmented reality navigation-guided pulmonary nodule localization in a canine model. Transl Lung Cancer Res. 2021 Nov;10(11):4152-4160. doi: 10.21037/tlcr-21-618.