Microsurgical Resection of Intramedullary Spinal Cord Metastases

Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study

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)

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Neoplasms; Radiotherapy; Complications; Functional Outcome; Spinal Cord Metastasis; Spinal Cord Tumor Malignant Intramedullary
• Intervention / Treatment: Procedure: Microsurgical resection of ISCM

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Martin N. Stienen, PD, MD; Phone Number: +41 71 494 2183; Email: martin.stienen@kssg.ch
• Study Contact Backup: Name: Felix C. Stengel, MD; Phone Number: +41 71 494 2184; Email: felix.stengel@kssg.ch

Study Locations

• Switzerland
  • Saint Gallen, Switzerland, 9000
    • Recruiting
    • Cantonal Hospital St. Gallen, Neurosurgery
    • Contact: Martin N. Stienen, PD, MD; Phone Number: +41714942183; Email: martin.stienen@kssg.ch
    • Contact: Felix C. Stengel, MD; Phone Number: +41714942184; Email: felix.stengel@kssg.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Patients under the age of 18

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 6 and 12 months after treatment initiation
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	within 90 days after treatment initiation
Functional outcome	modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy	at 3, 6 and 12 months after treatment initiation
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.	at 6 and 12 months after treatment initiation

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Collaborators: University Hospital, Geneva; University Hospital Muenster; Stanford University; University of Toronto; Kantonsspital Aarau; Luzerner Kantonsspital; University Hospital, Zürich; Kantonsspital Winterthur KSW; Klinikum rechts der Isar Technische Universität München; Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Martin N. Stienen, PD, MD, Cantonal Hospital St. Gallen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Spinal cord metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Spinal Cord Neoplasms
• Other Study ID Numbers: 2023-00292

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No