Microsurgical Resection of Intramedullary Spinal Cord Metastases
Study Details
Study Description
Brief Summary
The aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients.
The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively.
Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients.
The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment.
Primary endpoint (analysed in surgically treated ISCM patients):
Functional outcome at 90 days after treatment initiation, measured by the modified Japanese Orthopaedic Association (mJOA) scale. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy.
Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment):
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Functional outcome (mJOA) at 6 and 12 months
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Ambulatory status and continence at 90 days, 6 & 12 months (determined by mJOA subscores)
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Neurological outcome, measured by American Spinal Cord Injury Association (ASIA) Impairment Scale at 90 days, 6 and 12 months
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Rate & type of complications at 90 days after treatment according to The Novel Therapy Disability-Neurology Grade (TDN grade)16
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Overall survival (in days)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| iscm_resection -Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by resection of the ISCM with or without adjuvant radiotherapy |
Procedure: Microsurgical resection of ISCM
Microsurgical resection of ISCM defines the surgical removal of cancerous tumors that have spread to the spinal cord, using advanced microsurgical techniques and equipment like ultrasound, neuromonitoring, ultrasonic aspirator to prevent damage to the spinal cord.
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| iscm_radiotherapy -Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by radiotherapy without resection of the ISCM |
Outcome Measures
Primary Outcome Measures
- Functional outcome at 90 days after treatment initiation [at 90 days after treatment initiation]
measured by the modified Japanese Orthopaedic Association (mJOA) scale. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy
Secondary Outcome Measures
- Functional outcome [at 6 and 12 months after treatment initiation]
modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy
- Neurological outcome [at 6 and 12 months after treatment initiation]
measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A: Complete. No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing B: Sensory Incomplete. Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body C: Motor Incomplete. Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2) D: Motor Incomplete. Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3 E: Normal. If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits
- Rate & type of complications [within 90 days after treatment initiation]
Therapy-Disability-Neurology Grade (TDN Grade) Range: Grade 1-5 The Therapy-Disability-Neurology (TDN) grading system is a novel multidimensional classification of complications severity. higher Grades indicate higher severity of complication
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients admitted to one of the participating centres and treated for ISCM
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Available documentation of admission and postoperative status
Exclusion Criteria:
- Patients under the age of 18
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cantonal Hospital St. Gallen, Neurosurgery | Saint Gallen | Switzerland | 9000 |
Sponsors and Collaborators
- Cantonal Hospital of St. Gallen
- University Hospital, Zürich
- Insel Gruppe AG, University Hospital Bern
- University Hospital, Geneva
- Kantonsspital Aarau
- Kantonsspital Winterthur KSW
- Luzerner Kantonsspital
- Klinikum rechts der Isar Technische Universität München
- University Hospital Muenster
- University of Toronto
- Stanford University
Investigators
- Principal Investigator: Martin N. Stienen, PD, MD, Cantonal Hospital St. Gallen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-00292