Microsurgical Resection of Intramedullary Spinal Cord Metastases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCantonal Hospital of St. Gallen

About this trial

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 McCormick Scale. This is a score for grading of neurological function in spinal cord conditions.

The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment):

* Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months. 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. * Ambulatory status and continence at 90 days, 6 \& 12 months (determined by mJOA subscores) * Neurological outcome, measured by American Spinal Cord Injury Association (ASIA) * Impairment Scale at 90 days, 6 and 12 months * Rate \& type of complications at 90 days after treatment according to The Novel Therapy * Disability-Neurology Grade (TDN grade)16 * Overall survival (in days)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients admitted to one of the participating centres and treated for ISCM

Available documentation of admission and postoperative status

Disqualifiers

None

Trial population

The study population consists of patients who have undergone treatment for ISCM at one of the participating hospitals in the period from 2017 to 2023. The study period is chosen, as electronic documentation is available at all hospitals in this time-period. Patients will be identified by generated lists from neurosurgery (microsurgical procedures for ISCM) and radiooncology (radiotherapy for ISCM).

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Microsurgical resection of ISCM

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: iscm_resection1 intervention
Group B: iscm_radiotherapy0 interventions

Trial outcomes

Primary outcomes

1

Functional outcome at 90 days after treatment initiation

measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

Time frame
at 90 days after treatment initiation

Secondary outcomes

1

Functional outcome

modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy

Time frame
at 3, 6 and 12 months after treatment initiation
2

Neurological outcome

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

Time frame
at 6 and 12 months after treatment initiation
3

Rate & type of complications

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

Time frame
within 90 days after treatment initiation
4

Functional outcome

measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

Time frame
at 6 and 12 months after treatment initiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cantonal Hospital of St. Gallen

Lead sponsor

University Hospital, Zürich

Collaborator

Insel Gruppe AG, University Hospital Bern

Collaborator

University Hospital, Geneva

Collaborator

Kantonsspital Aarau

Collaborator

Kantonsspital Winterthur KSW

Collaborator

Luzerner Kantonsspital

Collaborator

Klinikum rechts der Isar Technische Universität München

Collaborator

University Hospital Muenster

Collaborator

University of Toronto

Collaborator

Stanford University

Collaborator