A Registry-Based Cohort Study on the Clinical Outcomes of Spinal Cord Glioma Resection Via the Dorsolateral Sulcus Approach

NCT ID: NCT07066475

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-12-31

Brief Summary

Spinal cord gliomas are the most common type of primary intramedullary malignant tumors, with a low incidence and a peak onset age of approximately 35 years. They are slightly more prevalent in males than females. Clinical manifestations vary depending on tumor characteristics and location, typically presenting with axial pain and displaying a tendency for unilateral, infiltrative growth. Prognosis is generally poor, and effective treatment options are limited aside from surgical resection. Common surgical approaches for intramedullary tumor removal include the posterior median sulcus approach, the dorsolateral sulcus approach, and surface entry techniques.

Preliminary clinical observations suggest that the dorsolateral sulcus approach may offer superior preservation of neurological function and quality of life. However, due to limited research evaluating the safety and efficacy of different surgical routes, the traditional posterior median sulcus approach remains widely used.

This single-center, registry-based cohort study aims to compare the outcomes of spinal cord glioma resection via the dorsolateral sulcus approach versus the posterior median sulcus approach. Patients with laterally located tumors undergoing surgical treatment, classified according to the 2021 WHO criteria, will be included. Neurological function scores and quality-of-life assessments will be used to evaluate prognosis and survival, in order to determine the optimal surgical approach for spinal cord glioma resection.

Detailed Description

Spinal cord gliomas are rare primary intramedullary tumors characterized by lateralized infiltrative growth and limited treatment options beyond surgical resection. Due to the anatomical complexity and functional sensitivity of the spinal cord, the choice of surgical approach significantly impacts postoperative neurological outcomes.

The traditional posterior median sulcus (PMS) approach provides direct midline access for tumor removal but carries a considerable risk of damage to central neural tracts. The dorsolateral sulcus (DLS) approach offers an alternative route for laterally located tumors, potentially sparing critical midline structures and improving functional outcomes.

This single-center, registry-based cohort study aims to evaluate and compare the clinical outcomes of spinal cord glioma resections performed via the DLS and PMS approaches. Patients will be enrolled based on eligibility criteria including lateralized tumor growth confirmed by imaging and histopathology, in accordance with the 2021 WHO classification of CNS tumors.

Primary and secondary outcomes will be assessed using validated clinical scales, including:

Visual Analog Scale (VAS) for pain assessment McCormick Functional Grading Scale Japanese Orthopaedic Association (JOA) Score for spinal cord function SF-36 Health Survey for quality of life evaluation Functional assessment of posterior column integrity Outcome assessments will be performed at five scheduled time points: preoperatively, and postoperatively at 1 month, 3 months, 6 months, and at the last follow-up visit. The study will evaluate neurological recovery, extent of resection, tumor recurrence, postoperative complications, and overall survival. This research aims to identify the optimal surgical approach that maximizes tumor resection while preserving neurological function in patients with spinal cord gliomas.

Conditions

Spinal Cord Cancer; Spinal Cord Neoplasm; Spinal Cord Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

DLS Group

Patients who underwent tumor resection through the dorsolateral sulcus approach

No interventions assigned to this group

PMS Group

Patients who underwent tumor resection through the posterior median sulcus approach

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age between 3 and 75 years

2. Undergoing surgical resection of spinal cord tumor

3. Histopathological diagnosis of spinal cord glioma based on routine pathological examination

4. Availability of complete clinical data and willingness to participate in follow-up

5. Informed consent obtained from the patient and/or legal guardians or immediate family members

Exclusion Criteria

1. Age under 3 years or over 75 years

2. Receipt of radiotherapy, chemotherapy, or anti-tumor biological therapy within 1 month prior to enrollment

3. Receipt of immunotherapy within 3 months prior to enrollment

4. Participation in other clinical trials within 3 months prior to enrollment

5. History of severe allergic reactions or known allergy-prone constitution

6. Pregnant or breastfeeding women, or individuals of childbearing potential not using adequate contraception

7. Presence of other severe medical conditions or uncontrolled infections

8. History of drug abuse, substance misuse, chronic alcoholism, or HIV infection

9. Uncontrolled epileptic seizures or psychiatric disorders resulting in loss of self-control

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Yongzhi Wang, MD

Role: CONTACT

yongzhiwang_bni@163.com

+86 13466391736

Other Identifiers

KY2025-143-02

Identifier Type: -

Identifier Source: org_study_id