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

NCT02777398 | Unknown

• 1 other identifier: XJTU1AF-CRF-2015-020
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Neoplasms

Keywords

Intra-spinal Canal; Tumor; Minimal Invasive Surgery; Clinical Trial; Quadrant Channel

Outcome Measures

Primary Outcomes (1)

• Postoperational Length of Stay in Hospital

  The duration of hospital stay from the day after operation to the day of discharge.

  From the day after operation to up to 4 weeks after operation.

Secondary Outcomes (11)

• Operaion duration

  On the day of operation.

• Operative incision length

  On the day of operation.

• Blood loss in operation

  On the day of the surgery.

• Cost of the surgery

  On the day of the surgery.

• Post-operative drainage volume

  On the 1st day after operation.

Study Arms (2)

Trans-Quadrant Channel Surgery

EXPERIMENTAL

Patients in the experimental arm (experimental group, i.e. microsurgery through trans-Quadrant channel pathway) will be operated using Quadrant channel system. All the tumor resection will be operated through the Quadrant channel with assistance of microsurgical techniques.

Procedure: Trans-Quadrant Channel Surgery

Conventional Open Surgery

ACTIVE COMPARATOR

Patients in the active comparator arm (control group, i.e. conventional open surgery) will be operated using the conventional open surgery. All the tumor resection will be operated directly with conventional procedures. More posterior structures of spine will be removed.

Procedure: Conventional Open Surgery

Interventions

Trans-Quadrant Channel Surgery PROCEDURE

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.

Trans-Quadrant Channel Surgery

Conventional Open Surgery PROCEDURE

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.

Conventional Open Surgery

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Spinal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Bone Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Study Officials

• Gang Bao, MD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Bao, MD

CONTACT

0086-13700222132; baogang1973@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: May 19, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)