Clinical trial NCT05715996: Application of Mixed Reality Technique for Percutaneous Lung Nodule Localization: A Prospective, Randomized, Controlled Trial
Official title: Application of Mixed Reality Technique for Percutaneous Lung Nodule Localization: A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: mixed reality
Localization
sublobectomy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 74
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: DIAGNOSTIC

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. Male or female ≥ 18years of age;
2. There was no distant metastasis in preoperative clinical evaluation;
3. The attending physician evaluated and confirmed the need for lung nodule localization and sub-lobectomy;
4. Target lung nodule diameter ≤ 2cm
5. The inner edge of the target node is at least 2 cm from the pulmonary artery or pulmonary vein
6. preoperative ECOG physical state score 0/1;
7. Volunteer to participate in the study and sign the 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. The patient has uncontrollable mental illness and cannot make subjective assessment.
4. After being selected, severe complications (unable to tolerate surgery or anesthesia) occurred before operation are not suitable or the treatment plan of the study cannot be implemented as planned;
5. After being selected, the patient's condition changes and needs to be changed from elective surgery to emergency surgery after being confirmed by the competent doctor;
6. At any stage after entering the study, the patient voluntarily requests to withdraw or discontinue treatment due to personal reasons.

Primary outcomes:
measure: Accuracy of nodule localization
timeFrame: 30 minutes
Secondary outcomes:
measure: Operation duration
timeFrame: 30 minutes
measure: Incidence of complications
timeFrame: 7 days
measure: Radiation exposure dose
timeFrame: 30 minutes
measure: Postoperative puncture pain assessment
timeFrame: 7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zuodong Song
state: Shanghai
Study officials:
References: