Microsurgical Resection of Intramedullary Spinal Cord Metastases

NCT06042946 | Recruiting

• 1 other identifier: 2023-00292
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Spinal Cord Metastasis; Spinal Cord Tumor Malignant Intramedullary; Functional Outcome; Radiotherapy; Complications; Spinal Cord Neoplasms

Keywords

Spinal cord metastasis

Outcome Measures

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.

  at 90 days after treatment initiation

Secondary Outcomes (4)

• Functional outcome

  at 3, 6 and 12 months after treatment initiation

• Neurological outcome

  at 6 and 12 months after treatment initiation

• Rate & type of complications

  within 90 days after treatment initiation

• Functional outcome

  at 6 and 12 months after treatment initiation

Study Arms (2)

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

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

Interventions

Microsurgical resection of ISCM PROCEDURE

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.

iscm_resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• Adult patients admitted to one of the participating centres and treated for ISCM
• Available documentation of admission and postoperative status

You may not qualify if:

• \- Patients under the age of 18

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead
• 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

Study Sites (1)

Cantonal Hospital St. Gallen, Neurosurgery

Sankt Gallen, 9000, Switzerland

RECRUITING

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Martin N. Stienen, PD, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin N. Stienen, PD, MD

CONTACT

+41 71 494 2183; martin.stienen@kssg.ch

Felix C. Stengel, MD

CONTACT

+41 71 494 2184; felix.stengel@kssg.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Attending Neurosurgeon

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: September 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CH (1)