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

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.

Conditions

• Spinal Neoplasms

Interventions

PROCEDURE

Trans-Quadrant Channel Surgery

Patients in the experimental group will be general anaesthetized and placed in the prone position. Intra-operational electrophysiological monitoring will be used. Kirschner wire will be used to identify the position of the Quadrant channel with X-ray. After disinfection and draping, an incision of 3cm long and 2-3cm lateral to midline on the tumor side will be made. Soft tissues will be separated. Graded dilators will be used to establish Quadrant channel. Kerrison clamps will be used to expose the very local posterior spinal structures. Vertebral plate will be windowed with power drill to expose dural mater, and tumors will be removed with microsurgical techniques. Hemostasis will be performed after resection. Dural mater will be closed by titanium clips, and close incision by layers.

PROCEDURE

Conventional Open Surgery

Patients in the control group will be general anaesthetized during operation and placed in the prone position. Intra-operational electrophysiological monitoring will be used. Surgeons will locate the lesion by X-ray. After disinfection and draping, the midline incision of 7-10 cm and centered by the lesion segment will be made. Soft tissues will be cut and separated to expose posterior structure of spine. The root of spinal process and half of the vertebral plate on tumor side of certain segments will be removed. The dural mater will be opened. Then surgeons will remove tumor with microsurgical techniques. Hemostasis will be precisely performed after resection, and dural mater will be closed by suturing. Incision will be closed by layers. Drainage would be placed if necessary.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University

  lead OTHER

Principal Investigators

• Gang Bao, MD · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2018-09-30

Completion

2018-09-30

Countries

• China

Study Locations