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临床试验/NCT06516471
NCT06516471尚未招募不适用

The Evolution of Safety and Efficacy of Neuroendoscopy Guided by Head-mounted Mixed Reality Technique Navigation System for Tumor Resection in Pineal Region and Brainstem: A Prospective, Randomized, Parallel-controlled Clinical Study

Shanghai Zhongshan Hospital0 个研究点目标入组 40 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Surgical time

研究概览

简要总结

The pineal region and brainstem tumors are located at the central position of the cranial cavity, surrounded by important neural structures and venous systems, leading to challenges in preoperative diagnosis, adding uncertainty and complexity to treatment. For a long time, surgical treatment of pineal region and brainstem tumors has been one of the most challenging areas in neurosurgery.

With the development of neuroendoscopy and virtual endoscopy technologies, how to convert complex three-dimensional bone, vascular, and neural images into virtual endoscopic images and how to combine virtual endoscopy with neuro-navigation for endoscopic skull base surgery to provide high-quality guidance images for surgery has become an urgent new research issue.

The project team plans to develop a neuroendoscopy combined with a wearable mixed reality glasses navigation system, integrating the advantages of wearable glasses and existing surgical navigation systems.

This study aims to evaluate the role of mixed reality navigation systems in improving total resection and reducing major complications in patients with pineal region and brainstem tumors, as well as shortening surgical times.

详细描述

The pineal region and brainstem tumors are located at the central position of the cranial cavity, surrounded by important neural structures and venous systems. They contain many crucial neural functional nuclei, making surgical exposure and resection difficult. Furthermore, the tumors in this region exhibit complex and diverse pathological types, including mixed tumors, leading to challenges in preoperative diagnosis, adding uncertainty and complexity to treatment. Pineal region tumors commonly cause obstructive hydrocephalus, resulting in severe preoperative intracranial hypertension symptoms, further complicating surgical management. For a long time, surgical treatment of pineal region and brainstem tumors has been one of the most challenging areas in neurosurgery.

With the development of neuroendoscopy and virtual endoscopy technologies, how to convert complex three-dimensional bone, vascular, and neural images into virtual endoscopic images and how to combine virtual endoscopy with neuro-navigation for endoscopic skull base surgery to provide high-quality guidance images for surgery has become an urgent new research issue.

The project team plans to develop a neuroendoscopy combined with a wearable mixed reality glasses navigation system, integrating the advantages of wearable glasses and existing surgical navigation systems. While ensuring the accuracy of the navigation system, the team aims to fundamentally change the output method of the system, enabling the surgical navigation system to go beyond mere validation of effects and truly play a role of "intuitive visual navigation." By holographically observing and tracking the relevant blood vessels and nerves in the patient's area, the team has achieved high-precision integration of virtual and real microanatomy structures, allowing for better and safer handling of deep-seated tumors under the endoscope. This study aims to evaluate the role of mixed reality navigation systems in improving total resection and reducing major complications in patients with pineal region and brainstem tumors, as well as shortening surgical times.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Preoperative suspicion of pineal region and brainstem tumors;
  • Age range from 18 to 70 years old;
  • Preoperative neurological function was good, with KPS>70 points;
  • Informed consent of patients and their families;

排除标准

  • Recurrent pineal region and brainstem tumors, previously received radiation therapy;
  • Combined with serious cardiovascular disease, other systemic malignancies, and other diseases;
  • Participants who participate in clinical trials of other drugs or devices but fail to achieve the main research endpoint;
  • The subjects are unable or unwilling to participate in this experiment
  • Preoperative discussion considers that patients are unable to undergo neurosurgical endoscopic surgery and require the use of microscopy or other techniques to assist in tumor resection;

结局指标

主要结局

Surgical time

时间窗: immedately after surgery

From openning the dura mater to close it

次要结局

  • The incidence of complications(within 1 month after surgery)
  • Gross total resection rate(within 72 hours after surgery)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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