Clinical trial NCT06117475: Posterior Corpectomy in Thoracolumbar Spinal Metastatsis
Official title: Short-term Outcomes of Posterior Corpectomy in Thoracolumbar Spinal Metastatsis in Assiut University Hospitals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spine Metastases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient diagnosed as a spinal metastatsis

Brief summary: To analyze the short-term outcomes of posterior corpectomy of patients with thoracolumbar spinal metastasis in spine unit in Assiut University hospital regarding the pain control , neurological status , complication and ambulatory status as well as mortality rate.

Detailed description: The metastasis is the spread of cancer from one part of the body to another. Two-thirds of patients with cancer will develop bone metastases. Breast, prostate and lung cancer are responsible for more than 80% of cases of metastatic bone disease. A spinal metastasis may cause pain, instability and neurological injuries.

* The spine is the most common site of bone metastasis . It is estimated that over the 10% of patients with cancer will develop a symptomatic spinal metastasis . Algra et al. suggest that the initial anatomic location of metastases within vertebrae is in the posterior portion of the body.
* Spinal metastases are the most common tumors of the spine, comprising approximately 90% of masses encountered with spinal imaging. Within the spinal column, metastasis is more commonly found in the thoracic region, followed by the lumbar region, while the cervical region is the least likely place professionals find metastasis .
* Spinal metastases most commonly affect the vertebral bodies of the spinal column, and spinal cord compression is an indication for surgery. Commonly, an open posterior approach is employed to perform a transpedicular, costotransversectomy or lateral extracavitary corpectomy. Because of the short life expectancies in patients with metastatic spinal disease, decreasing the morbidity of surgical treatment and recovery time is critical.
* At present, both surgical and nonsurgical treatments are used for the treatment of spinal tumors, however, treatment outcome is dependent on various factors, such as patient age, overall health of the patient .
* When treating patients with vertebral metastases, surgical strategy is mainly based on life expectancy, primary site of tumor, and staging. This helps determine which patients will benefit from surgery and the type of procedure. Tokuhashi developed a score to determine life expectancy in order to facilitate the treatment modality decision .
* Vertebral corpectomy refers to the removal of one or more vertebral bodies from the spine, as well as the intervertebral discs above and below the surgical level.

Corpectomies may be accomplished through a multitude of approaches. Posterior approaches have been associated with less intraop- erative blood loss, complications, shorter operative time, and better pul- monary function post-operation compared to anterior approaches .

Eligibility criteria: Inclusion Criteria:

Patients \> 18 years old Patient diagnosed as cancer Intractable pain Progressive neurologic comprise Radioresistant tumors

* Failure of radiotherapy
* Failure of chemotherapy
* Fit for surgery

Exclusion Criteria:

Patient younger 18 years old spinal 1ry tumor

Primary outcomes:
measure: Quality of patient life postoperatively
timeFrame: 5Q-ED score through complete the study about 1to 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohammed Gamal, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Essam Elmorshidy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Algra PR, Heimans JJ, Valk J, Nauta JJ, Lachniet M, Van Kooten B. Do metastases in vertebrae begin in the body or the pedicles? Imaging study in 45 patients. AJR Am J Roentgenol. 1992 Jun;158(6):1275-9. doi: 10.2214/ajr.158.6.1590123.
citation: Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002 Aug;2(8):584-93. doi: 10.1038/nrc867.
citation: Lau D, Chou D. Posterior thoracic corpectomy with cage reconstruction for metastatic spinal tumors: comparing the mini-open approach to the open approach. J Neurosurg Spine. 2015 Aug;23(2):217-27. doi: 10.3171/2014.12.SPINE14543. Epub 2015 May 1.
citation: Bilsky MH, Lis E, Raizer J, Lee H, Boland P. The diagnosis and treatment of metastatic spinal tumor. Oncologist. 1999;4(6):459-69.
citation: Gruenberg M, Mereles ME, Willhuber GOC, Valacco M, Petracchi MG, Sola CA. Usefulness of Tokuhashi Score in Survival Prediction of Patients Operated for Vertebral Metastatic Disease. Global Spine J. 2017 May;7(3):260-265. doi: 10.1177/2192568217699186. Epub 2017 Apr 11.
citation: Lin B, Chen ZW, Guo ZM, Liu H, Yi ZK. Anterior Approach Versus Posterior Approach With Subtotal Corpectomy, Decompression, and Reconstruction of Spine in the Treatment of Thoracolumbar Burst Fractures: A Prospective Randomized Controlled Study. J Spinal Disord Tech. 2012 Aug;25(6):309-317. doi: 10.1097/BSD.0b013e3182204c53.