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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02934594
Other study ID # 201608007RIND
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 11, 2016
Last updated October 13, 2016
Start date October 2016
Est. completion date August 2020

Study information

Verified date October 2016
Source National Taiwan University Hospital
Contact Shu-Hua Yang, M.D., Ph.D.
Phone 886-2-23123456
Email 005964@ntuh.gov.tw
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 99 Years
Eligibility 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.

Study Design

Observational Model: Case-Only


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

References & Publications (2)

Tokuhashi Y, Matsuzaki H, Oda H, Oshima M, Ryu J. A revised scoring system for preoperative evaluation of metastatic spine tumor prognosis. Spine (Phila Pa 1976). 2005 Oct 1;30(19):2186-91. — View Citation

Tomita K, Kawahara N, Kobayashi T, Yoshida A, Murakami H, Akamaru T. Surgical strategy for spinal metastases. Spine (Phila Pa 1976). 2001 Feb 1;26(3):298-306. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary survival rate 5 years No
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