PRELIMINARY REPORT e-ISSN 1643-3750 © Med Sci Monit, 2014; 20: 556-563 DOI: 10.12659/MSM.889742
A preliminary study of the safety and efficacy of radiofrequency ablation with percutaneous kyphoplasty for thoracolumbar vertebral metastatic tumor treatment
Received: 2013.09.02 Accepted: 2013.10.25 Published: 2014.04.04
Authors’ Contribution: Study Design A Data Collection B Analysis C Statistical Data Interpretation D Manuscript Preparation E Literature Search F Collection G Funds
E 1 B 1 D 1 E 1 E 1 E 2,3 A 1,2
Corresponding Author: Source of support:
Background:
Material/Methods:
Results:
Conclusions:
MeSH Keywords:
Full-text PDF:
Longpo Zheng* Zhengqi Chen* Mengxiong Sun Hui Zeng Dongqing Zuo Yingqi Hua Zhengdong Cai
1 Department of Orthopedics, Shanghai 10th People’s Hospital, Tongji University School of Medicine, Shanghai, China 2 Musculoskeletal Oncology Center, Shanghai 10th People’s Hospital, Tongji University School of Medicine, Shanghai, China 3 Advanced Institute of Translational Medicine, Tongji University, Shanghai, China
* These two authors contributed equally to this work Zhengdong Cai, e-mail: [email protected] and Yingqi Hua, e-mail: [email protected] Departmental sources
Thoracolumbar vertebral metastasis (TVM) affects a large number of cancer patients. However, safe and effective palliative care remains controversial. The aim of the present study was to investigate the safety and efficacy of minimally invasive image-guided radiofrequency ablation (RFA) with percutaneous kyphoplasty (PKP) for TVM treatment. A retrospective study of 26 patients (mean age: 59.31±11.62 years) was conducted, including 38 vertebral metastases at T11, T12, L1, L2, L3, L4, L5, and S1 with abundant blood vessels. Patients underwent RFA with PKP (4–6 min, 95±5°C, 150 W, effective electrode area of 1.5–2.0 cm) under general anesthesia from February 2005 to January 2009. Electrodes were inserted into the lesions and pre- and post-operative visual analog scale (VAS) scores and X-rays were collected on day 3, week 1, and months 1, 3, and 6. Tumor recurrence and pain level were also evaluated. Safety assessment was conducted based on complications and adverse events. The mean follow-up time was 8.4±2.1 months. A mean of 2.69±0.93 ablation was performed per patient. The ablation procedure required a mean of 15.08±4.64 min, while the injection of bone cement required a mean of 6.73±0.83 min, for a mean total operating time of 47.77±7.13 min. Postoperative VAS scores were significantly lower on day 3, week 1, and months 1, 3, and 6 (P65 years additionally completed heart and lung function assessments. Tumor location, size, and proximity to adjacent tissues/organs were examined, and anatomical examination of the pedicle was conducted. Appropriate electrode type, puncture site, and needle insertion angle were selected using these parameters, as previously described [20], and based on the operator’s judgment. In case of abnormal, large, multiple, or irregularly shaped bone metastases, multiple needle punctures were required to reach the ablation range sufficient to achieve an effective 2-puncture radius overlap of 30-50%, as previously described [21]. Preoperative digital subtraction angiography (DSA) and local vascular gel foam embolization were performed when necessary. Tumor biopsy Tumor biopsy was performed in all patients. Patients were placed in the prone position under general anesthesia. The skin around the incision was disinfected with Anerdian (Shanghai Likang Disinfectant Hi-tech Co., Shanghai, China). Unilateral or bilateral transpedicular needle insertion was conducted using CT or C-arm X-ray equipment for visualization (operative field diameter=30 cm). Using this path, a bone biopsy needle (Cook Medical, Bloomington, IN, USA) was inserted. Lesion biopsy specimens were sampled and pathologically examined using routine methods. Surgical intervention Intravenous steroids were administered to all patients before surgery to prevent anaphylactic reactions to bone cement. Immediately following biopsy, an appropriately sized ablation electrode was inserted along the same path as the biopsy needle. The size of the electrode was selected according to the desired effect diameter (2.0, 2.5, or 4.0 cm). The cathode plate was affixed to the posterolateral lower limb and fully opened. Ablation was conducted continuously for 4-6 minutes at 95±5°C and 150 W, generating an effective diameter of 1.5–2.0 cm. The ablation electrode was inserted into the lesion center or adjusted for multiple ablation. The electrode was
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License
then slowly removed, and thermocoagulation was performed on the percutaneous puncture to prevent bleeding. The procedure was repeated, if necessary, based on lesion scope and size. When possible, ablation was extended 0.5–1.0 cm outside the tumor boundary, avoiding nerves, blood vessels, and vital organs (Figure 1A, 1B). A unilateral or bilateral balloon was implanted and inflated with a dedicated balloon pressurizer (Medtronic, Fridley, MN, USA) (Figure 1C). Excessive dilation was avoided to prevent vertebral re-fracture and balloon rupture. A 3–5 ml (~1.5 ml inside tube) volume of bone cement (Tianjin Synthetic Material research Institute, Tianjin, China) was slowly pushed into the vertebral cavity, filling it completely while avoiding leakage (Figure 1D, 1E). Then, the injector and cannula were removed, avoiding cement tail formation. The incision in the percutaneous puncture site was sutured using 1 to 2 Ethicon sutures (Johnson & Johnson, New Brunswick, NJ, USA). Postsurgical care Immediately after surgery, antibiotic treatments (cefradine IV, 2 g/12 h for 3 days) were administered for 3 days to prevent infection, and glucocorticoids (dexamethasone IV, 10 mg/day for 3 days, 5 mg/day on the fourth day) were administered as needed to prevent swelling. Local pain was treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotics, including indomethacin (100 mg) suppository and bucinnazine (100 mg) intramuscular injection. Six h after disappearance of the anesthetic effect, a bolus dose of non-steroidal anti-inflammatory drug (celecoxib 200 mg or fenbid 300 mg) was administered to ease pain at the puncture site. Follow-up Patients were followed up for a minimum of 3 months, and up to 18 months. Clinical assessments were conducted postoperatively at day 3, week 1, and months 1, 3, and 6. At each examination, visual analogue scales (VAS) scores were selfreported and recorded on a 0–10 point scale to indicate pain. Outcomes of tumor recurrence and pain levels were examined at each follow-up visit.
558
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Zheng L. et al.: Radiofrequency ablation with percutaneous kyphoplasty © Med Sci Monit, 2014; 20: 556-563
PRELIMINARY REPORT
Table 1. Patient general information and preoperative and postoperative VAS score.
Patient
Age
Gender
Primary cancer
FollowLesion Preoperative up Location no. VAS (months)
Postoperative VAS
Analgesic
3d
1w
1m
3m
6m
1
62
M
Prostate
18
3
L2, L4
6
5
2
2
2
3
U
2
54
M
Liver
6
2
T11, T12
7
6
3
3
2
3
U
3
43
F
Lymphoma
3
2
L1
9
7
4
4
3
2
N
4
41
F
Mesenchymal malignant tumor
4
2
L1
6
6
2
3
2
3
N
5
70
M
Prostate
9
2
L2
9
8
4
3
3
2
U
6
37
M
Sacrum
8
2
L4, S1
7
7
2
2
2
3
N
7
75
M
Sacrum
7
2
L5, s1
8
8
3
3
2
2
U
8
32
F
Breast
6
2
L4, L5
7
8
2
2
2
3
U
9
64
F
Breast
8
2
T11, L1
7
7
5
4
3
2
U
10
62
F
Lung
7
1
T12, L2
8
6
5
3
4
3
N
11
57
M
Prostate
5
1
L2
8
8
4
5
3
4
U
12
68
F
Thyroid
14
2
T11
8
7
5
3
3
4
N
13
69
M
Prostate
13
1
L4
7
5
5
3
2
2
U
14
46
F
Breast
12
1
L3
8
6
7
4
4
3
N
15
58
F
Breast
10
1
T12
6
5
4
3
2
2
U
16
59
F
Esophagus
8
2
L2, L3
6
7
6
5
3
4
U
17
63
M
Adenocarcinoma
13
2
L4
7
6
6
5
2
2
U
18
58
M
Kidney
7
1
S1
8
7
5
4
4
4
N
19
65
F
Kidney
5
2
L1, L2
8
8
6
3
4
3
U
20
64
F
Breast
7
2
T12
9
5
6
3
2
2
N
21
55
F
Lymphoma
4
2
L4
7
6
5
5
3
3
N
22
80
M
Prostate
9
1
T12
8
7
6
4
4
2
N
23
57
M
Liver
5
2
L2, T12
10
8
5
5
2
3
N
24
69
M
Lung
6
1
L4
8
6
6
4
3
5
N
25
70
F
Lung
6
2
T11, L2
8
7
6
4
2
3
U
26
64
F
Breast
16
1
T12, L1
10
6
7
5
4
5
N
8.31 ±3.87
1.68 ±0.56
Total
59.31± 12:14* 11.62
7.69± 1.12
6.62± 4.65± 3.62± 2.77± 2.96± 1.02 1.55 0.98 0.82 0.92
12:14*
D – day; w – week; m – month; N – not used; U – used. * M: F or U: N.
Efficacy assessments
Safety assessments
Stability outcomes were assessed by postsurgical X-ray to measure vertebral height.
Complications and adverse events (AEs) at each follow-up visit were used to assess safety.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License
559
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Zheng L. et al.: Radiofrequency ablation with percutaneous kyphoplasty © Med Sci Monit, 2014; 20: 556-563
PRELIMINARY REPORT
A
B
C
D
E
Figure 2. T11 and L1 metastasis from breast cancer before and after RFA+PKP treatment. (A) ECT scan; (B) sagittal MRI; (C) T11 axial MRI; (D) L1 axial MRI; (E) X-ray showing the vertebrae after RFA+PKP, more precisely the bone cement in the inferior articular process of the vertebra.
Figure 3. Imaging of thoracolumbar metastatic tumors representing changes in vertebral height before and after treatment.
Statistical analysis SPSS 11.0 (SPSS, Inc., Chicago, IL, USA) was used for all data analysis. Pre- and postoperative VAS scores were compared using paired t-tests. P-values
A preliminary study of the safety and efficacy of radiofrequency ablation with percutaneous kyphoplasty for thoracolumbar vertebral metastatic tumor treatment
Received: 2013.09.02 Accepted: 2013.10.25 Published: 2014.04.04
Authors’ Contribution: Study Design A Data Collection B Analysis C Statistical Data Interpretation D Manuscript Preparation E Literature Search F Collection G Funds
E 1 B 1 D 1 E 1 E 1 E 2,3 A 1,2
Corresponding Author: Source of support:
Background:
Material/Methods:
Results:
Conclusions:
MeSH Keywords:
Full-text PDF:
Longpo Zheng* Zhengqi Chen* Mengxiong Sun Hui Zeng Dongqing Zuo Yingqi Hua Zhengdong Cai
1 Department of Orthopedics, Shanghai 10th People’s Hospital, Tongji University School of Medicine, Shanghai, China 2 Musculoskeletal Oncology Center, Shanghai 10th People’s Hospital, Tongji University School of Medicine, Shanghai, China 3 Advanced Institute of Translational Medicine, Tongji University, Shanghai, China
* These two authors contributed equally to this work Zhengdong Cai, e-mail: [email protected] and Yingqi Hua, e-mail: [email protected] Departmental sources
Thoracolumbar vertebral metastasis (TVM) affects a large number of cancer patients. However, safe and effective palliative care remains controversial. The aim of the present study was to investigate the safety and efficacy of minimally invasive image-guided radiofrequency ablation (RFA) with percutaneous kyphoplasty (PKP) for TVM treatment. A retrospective study of 26 patients (mean age: 59.31±11.62 years) was conducted, including 38 vertebral metastases at T11, T12, L1, L2, L3, L4, L5, and S1 with abundant blood vessels. Patients underwent RFA with PKP (4–6 min, 95±5°C, 150 W, effective electrode area of 1.5–2.0 cm) under general anesthesia from February 2005 to January 2009. Electrodes were inserted into the lesions and pre- and post-operative visual analog scale (VAS) scores and X-rays were collected on day 3, week 1, and months 1, 3, and 6. Tumor recurrence and pain level were also evaluated. Safety assessment was conducted based on complications and adverse events. The mean follow-up time was 8.4±2.1 months. A mean of 2.69±0.93 ablation was performed per patient. The ablation procedure required a mean of 15.08±4.64 min, while the injection of bone cement required a mean of 6.73±0.83 min, for a mean total operating time of 47.77±7.13 min. Postoperative VAS scores were significantly lower on day 3, week 1, and months 1, 3, and 6 (P65 years additionally completed heart and lung function assessments. Tumor location, size, and proximity to adjacent tissues/organs were examined, and anatomical examination of the pedicle was conducted. Appropriate electrode type, puncture site, and needle insertion angle were selected using these parameters, as previously described [20], and based on the operator’s judgment. In case of abnormal, large, multiple, or irregularly shaped bone metastases, multiple needle punctures were required to reach the ablation range sufficient to achieve an effective 2-puncture radius overlap of 30-50%, as previously described [21]. Preoperative digital subtraction angiography (DSA) and local vascular gel foam embolization were performed when necessary. Tumor biopsy Tumor biopsy was performed in all patients. Patients were placed in the prone position under general anesthesia. The skin around the incision was disinfected with Anerdian (Shanghai Likang Disinfectant Hi-tech Co., Shanghai, China). Unilateral or bilateral transpedicular needle insertion was conducted using CT or C-arm X-ray equipment for visualization (operative field diameter=30 cm). Using this path, a bone biopsy needle (Cook Medical, Bloomington, IN, USA) was inserted. Lesion biopsy specimens were sampled and pathologically examined using routine methods. Surgical intervention Intravenous steroids were administered to all patients before surgery to prevent anaphylactic reactions to bone cement. Immediately following biopsy, an appropriately sized ablation electrode was inserted along the same path as the biopsy needle. The size of the electrode was selected according to the desired effect diameter (2.0, 2.5, or 4.0 cm). The cathode plate was affixed to the posterolateral lower limb and fully opened. Ablation was conducted continuously for 4-6 minutes at 95±5°C and 150 W, generating an effective diameter of 1.5–2.0 cm. The ablation electrode was inserted into the lesion center or adjusted for multiple ablation. The electrode was
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License
then slowly removed, and thermocoagulation was performed on the percutaneous puncture to prevent bleeding. The procedure was repeated, if necessary, based on lesion scope and size. When possible, ablation was extended 0.5–1.0 cm outside the tumor boundary, avoiding nerves, blood vessels, and vital organs (Figure 1A, 1B). A unilateral or bilateral balloon was implanted and inflated with a dedicated balloon pressurizer (Medtronic, Fridley, MN, USA) (Figure 1C). Excessive dilation was avoided to prevent vertebral re-fracture and balloon rupture. A 3–5 ml (~1.5 ml inside tube) volume of bone cement (Tianjin Synthetic Material research Institute, Tianjin, China) was slowly pushed into the vertebral cavity, filling it completely while avoiding leakage (Figure 1D, 1E). Then, the injector and cannula were removed, avoiding cement tail formation. The incision in the percutaneous puncture site was sutured using 1 to 2 Ethicon sutures (Johnson & Johnson, New Brunswick, NJ, USA). Postsurgical care Immediately after surgery, antibiotic treatments (cefradine IV, 2 g/12 h for 3 days) were administered for 3 days to prevent infection, and glucocorticoids (dexamethasone IV, 10 mg/day for 3 days, 5 mg/day on the fourth day) were administered as needed to prevent swelling. Local pain was treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotics, including indomethacin (100 mg) suppository and bucinnazine (100 mg) intramuscular injection. Six h after disappearance of the anesthetic effect, a bolus dose of non-steroidal anti-inflammatory drug (celecoxib 200 mg or fenbid 300 mg) was administered to ease pain at the puncture site. Follow-up Patients were followed up for a minimum of 3 months, and up to 18 months. Clinical assessments were conducted postoperatively at day 3, week 1, and months 1, 3, and 6. At each examination, visual analogue scales (VAS) scores were selfreported and recorded on a 0–10 point scale to indicate pain. Outcomes of tumor recurrence and pain levels were examined at each follow-up visit.
558
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Zheng L. et al.: Radiofrequency ablation with percutaneous kyphoplasty © Med Sci Monit, 2014; 20: 556-563
PRELIMINARY REPORT
Table 1. Patient general information and preoperative and postoperative VAS score.
Patient
Age
Gender
Primary cancer
FollowLesion Preoperative up Location no. VAS (months)
Postoperative VAS
Analgesic
3d
1w
1m
3m
6m
1
62
M
Prostate
18
3
L2, L4
6
5
2
2
2
3
U
2
54
M
Liver
6
2
T11, T12
7
6
3
3
2
3
U
3
43
F
Lymphoma
3
2
L1
9
7
4
4
3
2
N
4
41
F
Mesenchymal malignant tumor
4
2
L1
6
6
2
3
2
3
N
5
70
M
Prostate
9
2
L2
9
8
4
3
3
2
U
6
37
M
Sacrum
8
2
L4, S1
7
7
2
2
2
3
N
7
75
M
Sacrum
7
2
L5, s1
8
8
3
3
2
2
U
8
32
F
Breast
6
2
L4, L5
7
8
2
2
2
3
U
9
64
F
Breast
8
2
T11, L1
7
7
5
4
3
2
U
10
62
F
Lung
7
1
T12, L2
8
6
5
3
4
3
N
11
57
M
Prostate
5
1
L2
8
8
4
5
3
4
U
12
68
F
Thyroid
14
2
T11
8
7
5
3
3
4
N
13
69
M
Prostate
13
1
L4
7
5
5
3
2
2
U
14
46
F
Breast
12
1
L3
8
6
7
4
4
3
N
15
58
F
Breast
10
1
T12
6
5
4
3
2
2
U
16
59
F
Esophagus
8
2
L2, L3
6
7
6
5
3
4
U
17
63
M
Adenocarcinoma
13
2
L4
7
6
6
5
2
2
U
18
58
M
Kidney
7
1
S1
8
7
5
4
4
4
N
19
65
F
Kidney
5
2
L1, L2
8
8
6
3
4
3
U
20
64
F
Breast
7
2
T12
9
5
6
3
2
2
N
21
55
F
Lymphoma
4
2
L4
7
6
5
5
3
3
N
22
80
M
Prostate
9
1
T12
8
7
6
4
4
2
N
23
57
M
Liver
5
2
L2, T12
10
8
5
5
2
3
N
24
69
M
Lung
6
1
L4
8
6
6
4
3
5
N
25
70
F
Lung
6
2
T11, L2
8
7
6
4
2
3
U
26
64
F
Breast
16
1
T12, L1
10
6
7
5
4
5
N
8.31 ±3.87
1.68 ±0.56
Total
59.31± 12:14* 11.62
7.69± 1.12
6.62± 4.65± 3.62± 2.77± 2.96± 1.02 1.55 0.98 0.82 0.92
12:14*
D – day; w – week; m – month; N – not used; U – used. * M: F or U: N.
Efficacy assessments
Safety assessments
Stability outcomes were assessed by postsurgical X-ray to measure vertebral height.
Complications and adverse events (AEs) at each follow-up visit were used to assess safety.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License
559
Indexed in: [Current Contents/Clinical Medicine] [SCI Expanded] [ISI Alerting System] [ISI Journals Master List] [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] [Chemical Abstracts/CAS] [Index Copernicus]
Zheng L. et al.: Radiofrequency ablation with percutaneous kyphoplasty © Med Sci Monit, 2014; 20: 556-563
PRELIMINARY REPORT
A
B
C
D
E
Figure 2. T11 and L1 metastasis from breast cancer before and after RFA+PKP treatment. (A) ECT scan; (B) sagittal MRI; (C) T11 axial MRI; (D) L1 axial MRI; (E) X-ray showing the vertebrae after RFA+PKP, more precisely the bone cement in the inferior articular process of the vertebra.
Figure 3. Imaging of thoracolumbar metastatic tumors representing changes in vertebral height before and after treatment.
Statistical analysis SPSS 11.0 (SPSS, Inc., Chicago, IL, USA) was used for all data analysis. Pre- and postoperative VAS scores were compared using paired t-tests. P-values
