The Evolution of Neuroendoscopy Guided by Head-mounted Mixed Reality Technique Navigation System in Neurosurgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Pineal Tumor; Brainstem Tumor
• Intervention / Treatment: Device: Conventinal Navigation System Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeyang Li, M.D.; Email: cqlizeyang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Recurrent pineal region and brainstem tumors, previously received radiation therapy;
2. Combined with serious cardiovascular disease, other systemic malignancies, and other diseases;
3. Participants who participate in clinical trials of other drugs or devices but fail to achieve the main research endpoint;
4. The subjects are unable or unwilling to participate in this experiment
5. 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mixed Reality Navigation System Group; Patients will receive receive surgery guided by mixed reality technique navigation system.	Device: Conventinal Navigation System Group; The preoperative planned model is projected onto the endoscopic display area in 3D using a mixed reality headset, accurately matching the actual anatomical structure and tissue displayed under the patient's endoscope to guide surgical resection of tumors.
Active Comparator: Conventinal Navigation System Group; Patients will receive receive surgery guided by traditional navigation system.	Device: Conventinal Navigation System Group; The preoperative planned model is projected onto the endoscopic display area in 3D using a mixed reality headset, accurately matching the actual anatomical structure and tissue displayed under the patient's endoscope to guide surgical resection of tumors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical time	From openning the dura mater to close it	immedately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross total resection rate	Gross total was defined as 100% of tumor resection	within 72 hours after surgery
The incidence of complications	new cranial nerve dysfunction, secondary surgery	within 1 month after surgery

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Infratentorial Neoplasms; Neoplasms; Brain Stem Neoplasms; Pinealoma
• Other Study ID Numbers: B2024-192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol ，CRF
• IPD Sharing Time Frame: When final results reported
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No