Surgical Treatment of Intra-spinal Canal Tumors Via Trans-Quadrant Channel — STRICT-TAQ  

Spinal Neoplasms Clinical Trial

Official title: The Prospcetive Randomized Controlled Trial of the Surgical Treatment of Intra-spinal Canal Tumors Using Microsurgical Technique Through Trans-Quadrant Channel Pathway

Status Recruiting

Clinical Trial Summary

Intra-spinal canal tumors are the general term of primary tumors from spinal cord or various tissues in the spinal canal and adjacent to the spinal cord, while the metastatic tumors are those from other sites other than spinal canal. Intra-spinal canal tumor is one of the most common diseases in neurosurgery, and surgery is the most effective treatment. Conventional open surgery is required to remove the posterior structures of the spine, which would lead to fracture of the posterior tension band, soft tissue injury, spine instability, and even spine deformity. So it is very important to protect and rebuild the posterior tension band for the stability of the spine. The team of Dr. John P. Kostuik from the Department of Orthopedics and Neurosurgery, the Johns Hopkins University, firstly introduced minimally invasive surgery for cervical and lumbar degenerative disease. However it has not been applied to the treatment of intra-spinal canal tumors. To date, the microsurgery of intra-spinal tumor through the trans-Quadrant channel pathway has not been widely performed in clinical practice. The investigators performed the microsurgery of intra-spinal canal tumor through the trans-Quadrant pathway in some patients previously and succeeded in the surgical treatments. The investigators analyzed the clinical data retrospectively, including surgical incision length, the volume of bleeding during operation, post-operative drainage volume, post-operative out-of-bed time point, post-operative length of stay in hospital, and post-operative visual analog pain (VAP) score. The group of patients using microsurgical technique through trans-Quadrant channel pathway showed better outcome compared with the group of patients using conventional open surgery. This innovation of microsurgery showed fewer traumas and bleeding, more rapid recovery, better prognosis and more safety in practice. Since there are some limitations to the retrospective study, it is necessary to design a prospective randomized controlled trial of the treatment of intra-spinal canal tumors using microsurgical technique through trans-Quadrant channel pathway.

Clinical Trial Description

This study is the prospective randomized controlled clinical trial.

1. Patient Recruitment: Patients who meets the diagnostic criteria of intra-spinal canal tumor and has surgical indications from May 2016 to June 2018 in the department of neurosurgery of our hospital could be recruited.

2. Screening: Demographic characteristics, such as gender, age, history of diseases (including but not limited in diabetes, heart disease, smoking history, and operation history, etc.), related laboratory tests (blood routing test, liver and kidney functions, electrolytes, blood coagulation function, and ECG, etc.) before entering either group.

3. Grouping: Patients who meets the diagnostic criteria and does not meet the exclusion criteria would be assigned into the experimental group and control group randomly. The informed consent forms should be signed before grouping.

4. Surgery: Patients in the experimental group will receive operation using microsurgical techniques through trans-Quadrant channel pathway. Patients in the control group will receive conventional open surgery.

5. Post-operative Observation and Follow-up: Clinical data will be collected after surgery and during follow-up. The time points include the 1st day, 7th day, 30th day, 90th day, and 180th day after surgery.

6. Statistical Analysis: Statisticians are blinded to the clinical data and grouping. The software SPSS (V. 16.0) will be used in statistics. ;

Related Conditions & MeSH terms

• Spinal Neoplasms

• NCT number: NCT02777398
• Study type: Interventional
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Gang Bao, MD
• Phone: 0086-13700222132
• Email: baogang1973@aliyun.com
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Completion date: September 2018