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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Extent of resection [Срок оценки: Preoperative MRI and MRI re-examinations conducted within 3 days after the surgery]
• Number of Participants with Preserved Dorsal Column Function (Assessed by clinical neurological examination and intraoperative electrophysiological monitoring ) [Срок оценки: Preoperative, 1 month, 6 months]
• Pain Level (VAS Score) [Срок оценки: Preoperative, 1 month postoperative, 6 months postoperative, and 12 months postoperative]
• Neurological Functional Status (McCormick Grade) [Срок оценки: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, and 12 months postoperative]

Вторичные конечные точки (3)

• SF-36 quality of life metrics [Срок оценки: 6 months and 12 months postoperative]
• Progression-Free Survival (PFS) [Срок оценки: From date of surgery until tumor progression or death, assessed up to 24 months]
• Overall Survival (OS) [Срок оценки: From date of surgery to death from any cause, assessed up to 36 months]

Критерии участия

Критерии включения

• Age between 3 and 75 years
• Undergoing surgical resection of spinal cord tumor
• Histopathological diagnosis of spinal cord glioma based on routine pathological examination
• Availability of complete clinical data and willingness to participate in follow-up
• Informed consent obtained from the patient and/or legal guardians or immediate family members

Критерии исключения

• Age under 3 years or over 75 years
• Receipt of radiotherapy, chemotherapy, or anti-tumor biological therapy within 1 month prior to enrollment
• Receipt of immunotherapy within 3 months prior to enrollment
• Participation in other clinical trials within 3 months prior to enrollment
• History of severe allergic reactions or known allergy-prone constitution
• Pregnant or breastfeeding women, or individuals of childbearing potential not using adequate contraception
• Presence of other severe medical conditions or uncontrolled infections
• History of drug abuse, substance misuse, chronic alcoholism, or HIV infection
• Uncontrolled epileptic seizures or psychiatric disorders resulting in loss of self-control

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07066475 · KY2025-143-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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