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Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate

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ClinicalTrials.gov Identifier: NCT02934594
Recruitment Status : Unknown
Verified October 2016 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
Patients with metastatic spinal cord compression (MSCC) are treated with different options according to the life expectancy. Survival and surgical outcome can be influenced by surgical timing in MSCC patients treated with palliative decompression.

Condition or disease Intervention/treatment
Neoplasm Metastasis Spinal Cord Compression Other: Palliative Decompression

Detailed Description:
MSCC patients who underwent palliative decompression after January 2012 in National Taiwan University Hospital (NTUH) were divided into the preoperative motor function intact group (Group A) and motor deficit group (Group B). The motor deficit group was subdivided into operation within 48 hours (Group B1), and after 48 hours (Group B2). All patients underwent palliative decompression and posterior stabilization. Investigators did wide laminectomy for tumor invading the vertebral body, and debulking surgery for tumor destructing the posterior column of the spine. Investigators retrospectively reviewed all patient records, including patient demographics, prognostic factors for survival (Kaplan-Meier survival analysis), neurological outcome (Frankel grade), primary tumor, complications, and relevance of Tomita and Tokuhashi scores.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Target Follow-Up Duration: 2 Years
Official Title: Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate
Study Start Date : October 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group A
Motor function intact group: received palliative decompression
 Other: Palliative Decompression
palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)
Group B1
motor deficit group: received palliative decompression within 48 hours after symptoms occured
 Other: Palliative Decompression
palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)
Group B2
motor deficit group: received palliative decompression 48 hours after symptoms occured
 Other: Palliative Decompression
palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)


Outcome Measures
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Primary Outcome Measures :
  1. survival rate [ Time Frame: 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression.
Criteria

Inclusion Criteria:

  • Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression in National Taiwan University Hospital after January 1st, 2012.

Exclusion Criteria:

  • Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression before December 31st, 2011, or those who were not treated in National Taiwan University Hospital.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934594


Contacts
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Contact: Shu-Hua Yang, M.D., Ph.D. 886-2-23123456 ext 63981 005964@ntuh.gov.tw

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Shu-Hua Yang, M.D., Ph.D. National Taiwan University Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02934594    
Other Study ID Numbers: 201608007RIND
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Spinal Cord Compression
Neoplastic Processes
Neoplasms
Pathologic Processes
 Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries