Spinal NeoplasmsSTRICT-TAQNCT02777398
Surgical Treatment of Intra-spinal Canal Tumors Via Trans-Quadrant Channel
A study testing Trans-Quadrant Channel Surgery and Conventional Open Surgery in people with Spinal Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Spinal Neoplasms
- What is being tested?
- Trans-Quadrant Channel Surgery and Conventional Open Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
Gang Bao, M.D., 0086-13700222132, baogang1973@aliyun.com
About this study
Official title: The Prospcetive Randomized Controlled Trial of the Surgical Treatment of Intra-spinal Canal Tumors Using Microsurgical Technique Through Trans-Quadrant Channel Pathway
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.
Read the detailed description
This study is the prospective randomized controlled clinical trial.
- 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.
- 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.
- 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.
- 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.
- 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.
- Statistical Analysis: Statisticians are blinded to the clinical data and grouping. The software SPSS (V. 16.0) will be used in statistics.
- Conditions
- Spinal Neoplasms
- Being tested
- Trans-Quadrant Channel Surgery, Conventional Open Surgery
- Keywords
- Intra-spinal Canal, Tumor, Minimal Invasive Surgery, Clinical Trial, Quadrant Channel
- Medical subject headings
- Spinal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-Quadrant Channel SurgeryProcedure or 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.
Conventional Open SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Open Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperational Length of Stay in Hospital
The duration of hospital stay from the day after operation to the day of discharge.
Measured: From the day after operation to up to 4 weeks after operation.
Secondary outcomes (11)
Operaion duration
The time duration of operation.
Measured: On the day of operation.
Operative incision length
The skin incision length of operation.
Measured: On the day of operation.
Blood loss in operation
The blood lost during operatioin.
Measured: On the day of the surgery.
Cost of the surgery
The cost of the surgery, including operation cost, blood cost, anesthetic cost, and material cost, etc.
Measured: On the day of the surgery.
Post-operative drainage volume
The drainage volume of surgery site from postoperation to the 1st day morning after operation.
Measured: On the 1st day after operation.
Post-operative VAS
The VAS scores on the 7th and 30th days after operation.
Measured: On the 7th day and 30th day after operation.
The improvement rate of Japanese Orthopaedic Association Scores (JOAS)
Collect the pre-operational JOAS score and the JOAS score on the 1st day after operation.
Measured: On the 1st day after operation.
The improvement rate of JOAS
Collect the pre-operational JOAS score and the JOAS score on the 7th day after operation.
Measured: On the 7th day after operation.
The improvement rate of JOAS
Collect the pre-operational JOAS score and the JOAS score on the 30th day after operation.
Measured: On the 30th day after operation.
The improvement rate of JOAS
Collect the pre-operational JOAS score and the JOAS score on the 90th day after operation.
Measured: On the 90th day after operation.
The improvement rate of JOAS
Collect the pre-operational JOAS score and the JOAS score on the 180th day after operation.
Measured: On the 180th day after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Bao, MD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777398
- Sponsor's protocol ID
- XJTU1AF-CRF-2015-020
- Acronym
- STRICT-TAQ
- Status last verified
- Mar 2018
- First submitted
- 8 May 2016
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospcetive Randomized Controlled Trial of the Surgical Treatment of Intra-spinal Canal Tumors Using Microsurgical Technique Through Trans-Quadrant Channel Pathway
- ClinicalTrials.gov ID
- NCT02777398
- Acronym / sponsor ID
- STRICT-TAQ / XJTU1AF-CRF-2015-020
- Conditions
- Spinal Neoplasms
- Keywords
- Intra-spinal Canal, Tumor, Minimal Invasive Surgery, Clinical Trial, Quadrant Channel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Statistical Analysis: Statisticians are blinded to the clinical data and grouping. The software SPSS (V. 16.0) will be used in statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-Quadrant Channel Surgery | Experimental | Procedure: Trans-Quadrant Channel SurgeryPatients 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. |
| Conventional Open Surgery | Active comparator | Procedure: Conventional Open SurgeryPatients 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-Quadrant Channel SurgeryPatients 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 or surgery | Trans-Quadrant Channel Surgery |
| Conventional Open SurgeryPatients 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. | Procedure or surgery | Conventional Open Surgery |
Primary outcome
Postoperational Length of Stay in Hospital
Time frame: From the day after operation to up to 4 weeks after operation.
The duration of hospital stay from the day after operation to the day of discharge.
11 secondary outcomes
Operaion duration
Time frame: On the day of operation.
Operative incision length
Time frame: On the day of operation.
Blood loss in operation
Time frame: On the day of the surgery.
Cost of the surgery
Time frame: On the day of the surgery.
Post-operative drainage volume
Time frame: On the 1st day after operation.
Post-operative VAS
Time frame: On the 7th day and 30th day after operation.
The improvement rate of Japanese Orthopaedic Association Scores (JOAS)
Time frame: On the 1st day after operation.
The improvement rate of JOAS
Time frame: On the 7th day after operation.
The improvement rate of JOAS
Time frame: On the 30th day after operation.
The improvement rate of JOAS
Time frame: On the 90th day after operation.
The improvement rate of JOAS
Time frame: On the 180th day after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Bao, MD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-Quadrant Channel Surgery and Conventional Open Surgery in people with Spinal Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Bao, MD (0086-13700222132, baogang1973@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperational Length of Stay in Hospital (time frame: From the day after operation to up to 4 weeks after operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.