Clinical trial NCT06548451: Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial
Official title: Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: augmented reality
localization
sublobectomy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 80 years inclusive;
2. No distant metastasis in preoperative clinical assessment;
3. The attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection;
4. Target lung nodule diameter is no more than 2 cm;
5. The inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein;
6. Non-pleural surface nodules;
7. Preoperative ECOG performance status score of 0/1;
8. Voluntarily participating in this study and signing an informed consent form.

Exclusion Criteria:

1. More than two lung nodules need to be removed at the same time.
2. The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
3. Patients with chronic pain issues or those who have been taking pain medications for an extended period.
4. Patients have uncontrollable mental illness and cannot make subjective assessment.

Primary outcomes:
measure: Effectiveness of sublobar resection
timeFrame: 120 minutes
Secondary outcomes:
measure: Operation duration
timeFrame: 30 minutes
measure: Interval time from localization to surgery
timeFrame: 60 minutes
measure: Complications related to nodule localization
timeFrame: 60 minutes
measure: Radiation exposure dose
timeFrame: 30 minutes
measure: Dislodgement rate of the hookwire
timeFrame: 120 minutes
measure: Accuracy of nodule localization
timeFrame: 30 minutes
measure: Post-localization pain assessment
timeFrame: 40 days
measure: Post-localization trauma stress disorder assessment
timeFrame: 40 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Hefei
country: China
facility: the people's second hospital Hefei
city: Jiangyin
country: China
facility: Jiangyin Hospital of Traditional Chinese Medicine
city: Jining
country: China
facility: Jining No. 1 People's Hospital.
city: Lianyungang
country: China
facility: Donghai County People's Hospital
city: Shijia Zhuang
country: China
facility: the First Hospital of Hebei Medical University
city: Zhangjiagang
country: China
facility: Zhangjiagang Hospital of Traditional Chinese Medicine,
Study officials:
References: