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临床试验/NCT06548451
NCT06548451已完成不适用

Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial

Shanghai Chest Hospital8 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
270
试验地点
8
主要终点
Effectiveness of sublobar resection

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •More than two lung nodules need to be removed at the same time.
  • •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.
  • •Patients with chronic pain issues or those who have been taking pain medications for an extended period.
  • •Patients have uncontrollable mental illness and cannot make subjective assessment.

研究组 & 干预措施

AR-guided group

Experimental

Application of augmented reality technique for percutaneous lung nodule localization.

干预措施: Augmented reality guided localization (Device)

CT-guided group

No Intervention

Computerized tomography (CT) guided percutaneous lung nodule localization.

结局指标

主要结局

Effectiveness of sublobar resection

时间窗: 120 minutes

The surgeon assesses whether effective lung sublobar resection has been achieved intraoperatively. Effective lung sublobar resection is defined as: (1) Completing planned sublobar resection in one session without the need for supplementary segmental or lobar resections; (2) Having a margin distance from the nodule of over 2 cm or at least 1 times the diameter of the nodule. If effective resection is not achieved, the proportion of supplementary segmental or lobar resections will be recorded.

次要结局

  • Complications related to nodule localization(60 minutes)
  • Operation duration(30 minutes)
  • Accuracy of nodule localization(30 minutes)
  • Post-localization trauma stress disorder assessment(40 days)
  • Interval time from localization to surgery(60 minutes)
  • Radiation exposure dose(30 minutes)
  • Dislodgement rate of the hookwire(120 minutes)
  • Post-localization pain assessment(40 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinghua Cheng

MD

Shanghai Chest Hospital

研究点 (8)

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