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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-75
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

This is a single-center registry study including patients aged 3-75 years who were diagnosed with spinal cord glioma by histopathology and underwent surgical resection. All participants provided informed consent and were able to complete follow-up assessments.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: DLS Group
Group B: PMS Group

Trial outcomes

Primary outcomes

1

Extent of resection

The extent of tumor resection was evaluated by comparing the preoperative and postoperative magnetic resonance images, and the criterion for judgment was that the tumor volume decreased by more than 50%.

Time frame
Preoperative MRI and MRI re-examinations conducted within 3 days after the surgery
2

Number of Participants with Preserved Dorsal Column Function (Assessed by clinical neurological examination and intraoperative electrophysiological monitoring )

Dorsal column function will be assessed through standardized clinical neurological examination, including evaluation of proprioception (joint position sense), vibration sense, and gait. Dysfunction is defined as the presence of generalized numbness or painful dysesthesias below the surgical level, accompanied by proprioceptive loss and/or gait disturbance. \* This definition is based on previously published clinical criteria for dorsal column dysfunction in patients with intramedullary spinal cord tumors, as described by Manzano et al.

Time frame
Preoperative, 1 month, 6 months
3

Pain Level (VAS Score)

Assessment of pain severity using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 100 (worst possible pain).

Time frame
Preoperative, 1 month postoperative, 6 months postoperative, and 12 months postoperative
4

Neurological Functional Status (McCormick Grade)

Evaluation of neurological status using the McCormick Functional Grading Scale to compare surgical approaches. The scale ranges from Grade I (normal gait and function) to Grade IV (severe disability or paraplegia).

Time frame
Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, and 12 months postoperative

Secondary outcomes

1

SF-36 quality of life metrics

Quality of life will be assessed using the 36-Item Short Form Survey (SF-36), a validated questionnaire that evaluates multiple health domains including physical functioning, bodily pain, general health, vitality, social functioning, emotional role, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.

Time frame
6 months and 12 months postoperative
2

Progression-Free Survival (PFS)

Progression-free survival is defined as the time from surgery to the first documented tumor progression or death from any cause. Progression is determined by imaging and/or neurological deterioration.

Time frame
From date of surgery until tumor progression or death, assessed up to 24 months
3

Overall Survival (OS)

Overall survival is defined as the time from surgery to death from any cause. Survival status will be monitored through clinic visits or follow-up contact.

Time frame
From date of surgery to death from any cause, assessed up to 36 months

Other outcomes

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