Clinical trial NCT02777398: Surgical Treatment of Intra-spinal Canal Tumors Via Trans-Quadrant Channel
Official title: The Prospcetive Randomized Controlled Trial of the Surgical Treatment of Intra-spinal Canal Tumors Using Microsurgical Technique Through Trans-Quadrant Channel Pathway
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Neoplasms
Keywords: Intra-spinal Canal
Tumor
Minimal Invasive Surgery
Clinical Trial
Quadrant Channel
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* The patient should meet the diagnostic criteria of intra-spinal canal tumors and the indications for surgery. Meanwhile, the length of tumor should no more than 5 cm, and the cross-sectional area should be less than 2/3 of the respective area of the spinal canal.
* The patient was never be treated with any spinal surgery.
* There was no cognitive impairment before onset of diseases or other diseases which can cause cognitive dysfunction.
* The patient should sign the informed consent forms.

Exclusion Criteria:

* The patient is diagnozed as non intra-spinal canal tumors, spinal degenerative diseases, or other spinal diseases.
* The patient received spinal surgery previously.
* The patient suffered from serious heart, lung, liver, or kidney insufficiency.
* The patient has other spinal and spinal cord diseases rather than intra-spinal canal tumor, such as disc herniation, vertebral fractures.
* The patient has severe diabetes, coronary heart disease, coagulation disorders, difficult to correct before operation, or cannot tolerate surgery.
* The patient has other surgical contraindications.
* The patient is pregnant or breast-feeding.
* The patient is unable to sign the informed consent voluntarily.

Primary outcomes:
measure: Postoperational Length of Stay in Hospital
timeFrame: From the day after operation to up to 4 weeks after operation.
Secondary outcomes:
measure: Operaion duration
timeFrame: On the day of operation.
measure: Operative incision length
timeFrame: On the day of operation.
measure: Blood loss in operation
timeFrame: On the day of the surgery.
measure: Cost of the surgery
timeFrame: On the day of the surgery.
measure: Post-operative drainage volume
timeFrame: On the 1st day after operation.
measure: Post-operative VAS
timeFrame: On the 7th day and 30th day after operation.
measure: The improvement rate of Japanese Orthopaedic Association Scores (JOAS)
timeFrame: On the 1st day after operation.
measure: The improvement rate of JOAS
timeFrame: On the 7th day after operation.
measure: The improvement rate of JOAS
timeFrame: On the 30th day after operation.
measure: The improvement rate of JOAS
timeFrame: On the 90th day after operation.
measure: The improvement rate of JOAS
timeFrame: On the 180th day after operation.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian JiaotongUniversity
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Gang Bao, MD
role: PRINCIPAL_INVESTIGATOR
References: