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Not yet recruitingNCT06117475Updated Nov 7, 2023

Posterior Corpectomy in Thoracolumbar Spinal Metastatsis

An observational study in Spine Metastases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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 .

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Conditions studied

  • Spine Metastases

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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 30 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patient diagnosed as a spinal metastatsis

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

Exclusion Criteria:

Patient younger 18 years old spinal 1ry tumor

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • ProcedurePosterior corpectomy

    Removal of posterior portion of vertebrae by posterior approach

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What researchers measure

Primary outcomes

  1. Quality of patient life postoperatively

    Measure quality of life postoperatively by mobility, self care , usual activity ( e.g work, study, housework ) , pain /discomfort and anxiety and depression by 5Q-ED score ( EUROQOL EUROQOL 5 Dimension 5 levels ). EQ-5D-5L profile data can be summarised in the same way. 11111 again means no problem on any of the five dimensions of health and the worst health state is 55555. 1 means no problem , 5 means unable to do

    Time frame: 5Q-ED score through complete the study about 1to 1.5 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Maccauro G, Spinelli MS, Mauro S, Perisano C, Graci C, Rosa MA. Physiopathology of spine metastasis. Int J Surg Oncol. 2011;2011:107969. doi: 10.1155/2011/107969. Epub 2011 Aug 10. PubMed 22312491 ↗
  • 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. PubMed 1590123 ↗
  • Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002 Aug;2(8):584-93. doi: 10.1038/nrc867. PubMed 12154351 ↗
  • 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. PubMed 25932599 ↗
  • Bilsky MH, Lis E, Raizer J, Lee H, Boland P. The diagnosis and treatment of metastatic spinal tumor. Oncologist. 1999;4(6):459-69. PubMed 10631690 ↗
  • 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. PubMed 28660109 ↗
  • 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. PubMed 21637134 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06117475
Lead sponsor
Assiut University
Responsible party
Rehab Mahmoud Ahmed Mohammed (Assiut lecturer, Assiut University) — Principal investigator
First posted
Nov 7, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Nov 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Nov 7, 2023

Study contacts

Rehab Ma Ahmed, Resident
Contact
rehabmahmoud@med.aun.edu.eg
01025345048
Mohammed Ga Hassan, Professor
Contact
m.gamal@aun.edu.eg
01001843084
Mohammed Gamal, Professor
principal investigator · Assiut University
Essam Elmorshidy, MD
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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