Clinical guidelines for microwave ablation of spinal metastases
Tao Yang1, Jin Ke1, Shi Cheng1, Yue He1, Wenhan Huang1, Mengyu Yao1, Jielong Zhou1, Guoqing Zhong1, Yongcheng Hu2, Yu Zhang1
1 Department of Orthopaedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangdong, China
2 Department of Bone Tumor, Tianjin Hospital, Tianjin, China
Correspondence Address:
Yongcheng Hu
Department of Bone Tumor, Tianjin Hospital, No. 406, Jiefang Southern Road, Hexi District, Tianjin - 300211
China
Yu Zhang
Department of Orthopaedics, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Number 106, 2nd Zhongshan Road, Yuexiu District, Guangzhou 510080, Guangdong
China
Source of Support: None, Conflict of Interest: None
CheckDOI: 10.4103/jcrt.jcrt_655_22
Spinal metastases are the most common source of morbidity in patients with cancer. Recently, microwave ablation has produced satisfactory results in the management of spinal metastases. However, there is still controversy in terms of clinical treatment, such as indication, power, time, and temperature. To standardize the application of microwave ablation technology and reduce the risk of surgical-related complications in spinal metastases, in this report, we aimed to summarize the current evidence and clinical experience of microwave ablation and developed a clinical guideline, initiated by the Musculoskeletal Tumor Group of the Committee for Minimally Invasive Therapy in Oncology of the Chinese Anti-Cancer Association. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used in to rate the quality of evidence and the strength of recommendations, and the Reporting Items for Practice Guidelines in Healthcare (RIGHT) checklist was strictly followed to report the guideline. Finally, 15 evidence-based recommendations were formulated based on the 15 most concerned clinical questions among orthopedic surgeons, oncologists, and interventional radiologists in China. This guideline aims to promote the science-based normalization of microwave ablation for the treatment of spinal metastases.
Keywords: Guideline, metastasis, microwave ablation, musculoskeletal tumor, thermotherapy
Microwave ablation is used for tumor treatment. It can promote the friction of polar molecules and generate heat in the tissue, leading to necrosis of tumor tissues.[1],[2] It has been widely applied to several kinds of tumors, such as liver, lung, kidney, prostate, and bone cancer.[3],[4],[5],[6],[7],[8],[9] Microwave ablation can not only inactivate tumors,[1] induce apoptosis,[10],[11] destroy tumor blood vessels,[12] and improve antitumor immunity,[13] but can also increase tumor sensitivity to chemotherapy.[14] At present, the effectiveness and safety of this technology have been recognized by most oncologist.[15],[16],[17],[18]
Microwave ablation has been used for the treatment of bone tumors for nearly 40 years. Lu et al.[19] first achieved good results with microwave ablation on bone tumors from 1980 to 1994. Since then, its application has expanded, not only in the different modes available, including irradiation and insertion,[19],[20],[21] open and percutaneous,[17],[22],[23] etc. The application scope includes primary malignant tumors,[8],[9],[20] metastatic malignant tumors,[7],[24],[25] and borderline tumors.[26],[27] The spine is the most common site of bone metastases. Currently, there is great controversy about microwave ablation of spinal metastases[28]; because of lack of knowledge and/or experience and limited clinical research evidence.
To standardize the application of microwave ablation to spinal metastases, experts from the Musculoskeletal Tumor Group of the Committee for Minimally Invasive Therapy in Oncology of the Chinese Anti-Cancer Association, and methodological experts discussed and formulated this clinical guideline informed by evidence-based medicine. This guideline describes percutaneous and open microwave ablation application to spinal metastases, involving indications, contraindications, operating techniques, and related complications. Recommendations 1–9 are related to percutaneous microwave ablation; recommendations 10–14 are related to open microwave ablation, and the last recommendation is related to microwave ablation equipment.
> Clinical Questions and RecommendationsIndications and contraindications of percutaneous microwave ablation for spinal metastases
Clinical question 1: Is percutaneous microwave ablation suitable for intractable pain caused by spinal metastases (without nerve compression or axial instability)?
Recommendation 1: Percutaneous microwave ablation is suitable for intractable pain caused by spinal metastases (without nerve compression or axial instability) (strong recommendation; evidence Level: D).
Conventional treatments include oral nonsteroidal antiinflammatory drugs, oral or subcutaneous or intravenous opioid pain killers, and radiation therapy. Pain that cannot be controlled by the above conventional analgesic strategies is defined as refractory pain, also known as intractable pain.[29]
To evaluate the clinical effect of percutaneous microwave ablation for intractable pain caused by spinal metastases, the authors searched PubMed, Web of Science, Embase, CNKI, and Wanfang database. We found 12 articles in total[30],[31],[32],[33],[34],[35],[36],[37],[38],[39],[40],[41] that describe the treatment of cancer pain due to spinal metastases. Percutaneous microwave ablation was used for 289 spinal metastases in nine articles,[30],[31],[32],[33],[34],[35],[36],[37],[38] and postoperative pain relief was satisfactory. The other three articles are comprehensive reports on the treatment of bone metastases by microwave ablation[39],[40],[41]; however, the clinical results were not separately scored and followed up on the pain of spinal metastases. Pusceddu et al.[39] used percutaneous microwave ablation for three spinal segmental lesions. The pain was significantly relieved in the first week after intervention, and the pain did not recur during the 3-month follow-up. Ke et al.[40] treated 24 patients with percutaneous microwave ablation, whose visual analog scale (VAS) score was >4 and had a life expectancy >3 months. The pain relief was satisfactory. Zhang et al.[41] did percutaneous microwave ablation in 161-diseased vertebrae of patients with intractable pain, a VAS score ≥4 and life expectancy ≥3 months. Although no specific analysis of pain scores for spinal metastases was performed in the study, the VAS score decreased from (6.4 ± 2.3) before the intervention to (1.8 ± 1.6) at 3 months thereafter. Therefore, percutaneous microwave ablation is suitable for intractable pain caused by spinal metastases (without nerve compression and axial instability).
Clinical question 2: Do lesions with different pathologic properties affect the efficacy of percutaneous microwave ablation?
Recommendation 2: Percutaneous microwave ablation can provide better pain relief for both osteolytic and osteogenic lesions (strong recommendation; evidence Level: D).
Lesions of different pathologic properties may all cause different pain intensities, spinal instability, pathological fractures, and other complications.[42] By searching the above databases, a total of 20 articles[15],[23],[30],[31],[32],[34],[35],[36],[37],[38],[39],[40],[41],[43],[44],[45],[46],[47],[48],[49] described the use of percutaneous microwave ablation for the treatment of spinal metastases. Five articles clearly distinguished the property of the lesions.[23],[34],[39],[40],[49] Lin et al.[49] studied the treatment of 27 patients (37 sites) with osteolytic bone metastases by percutaneous microwave ablation combined with cementoplasty. The pain numerical rating scale was significantly better than that before intervention. Only 18.9% (7/37) of the patients had minor complications (bone cement leakage). Ke et al.[40] used percutaneous microwave ablation for osteolytic and mixed lesions; the VAS of all patients on the 7th day, 1 month, and 3 months after surgery was significantly lower than before surgery. Percutaneous microwave ablation of osteogenic lesions can also relieve cancer pain.[34] This effect can also be achieved when the intervention is supplemented with bone cement filling.[39] Moreover, the treatment can maintain the stability of the patient's spine and improve their motor function.[23] Therefore, both osteoblastic and osteolytic spinal metastases can be treated with percutaneous microwave ablation, supplemented with bone cement filling to improve or reconstruct spinal stability.
Clinical question 3: Is percutaneous microwave ablation suitable for multi-segment spinal metastases?
Recommendation 3: Compared with single-segment ablation of spinal metastases, both two-segment and multi-segment ablation of spinal metastases can achieve the same therapeutic effect without increasing the surgery risk (strong recommendation; evidence Level: D).
To evaluate the efficacy and safety of microwave ablation for multi-segment spinal metastases, a total of 20 articles were included.[15],[23],[30],[31],[32],[34],[35],[36],[37],[38],[39],[40],[41],[43],[44],[45],[46],[47],[48],[49] Hu et al.[36] performed percutaneous microwave ablation combined with percutaneous vertebroplasty (PVP) on 42 lesions in 35 patients. All operations were successfully completed in both single-segment and double-segment cases. Jiao et al.[45] performed microwave ablation on 42 osteolytic lesions (including extremities) in 30 patients with either single-segment or double-segment lesions. In all cases, the operational procedure could be successfully completed. Khan et al.[35] performed microwave ablation combined with PVP on 102 spinal metastases in 69 patients. Of those, 94% (65/69) had immediate pain relief, and 96.7% had no local lesions progression in the 20–24 weeks follow-up. In addition, the study found no significant difference in the efficacy of percutaneous microwave ablation for single versus multiple spinal metastases. Therefore, microwave ablation for multi-segment spinal metastases is effective, safe, and feasible.
Clinical question 4: Can spinal metastases with nerve compression be treated with percutaneous microwave ablation?
Recommendation 4: For lesions adjacent to the spinal cord or nerve, percutaneous microwave ablation is a relative contraindication as increasing the operational risk (weak recommendation; evidence Level: D).
To evaluate the efficacy of percutaneous microwave ablation in the treatment of spinal metastases with spinal cord or nerve compression, a total of 20 articles were included by searching the above databases.[15],[23],[30],[31],[32],[34],[35],[36],[37],[38],[39],[40],[41],[43],[44],[45],[46],[47],[48],[49] Half of the studies (10/20) clearly indicated that nerve compression should be a contraindication to percutaneous microwave ablation. Only two studies took spinal metastases with spinal cord or nerve as inclusion criteria.[37],[38] Yang et al.[38] explored the efficacy of microwave ablation combined with PVP in the treatment of vertebral metastases. Forty cases were treated with microwave ablation combined with PVP and 40 cases with PVP alone. In this study, microwave ablation combined with PVP treatment led to better pain control and better quality of life six months after the intervention, but the neurological function was not assessed. In conclusion, percutaneous microwave ablation for lesions adjacent to the spinal cord or nerve may increase the operational risk, which is a relative contraindication.
Percutaneous microwave ablation-related surgical techniques
Clinical question 5: Does percutaneous microwave ablation of spinal metastases need to be performed under imaging (X-ray or CT) guidance?
Recommendation 5: Percutaneous microwave ablation of spinal metastases should be performed under the guidance of imaging (X-ray or CT) (strong recommendation; evidence Level: D).
To increase the accuracy of puncture and antenna arrangement, current percutaneous microwave ablation for spinal metastases is performed under image guidance (X-ray or CT). By searching the above databases, a total of 20 articles were included,[15],[23],[30],[31],[32],[34],[35],[36],[37],[38],[39],[40],[41],[43],[44],[45],[46],[47],[48],[49] corresponding to 477 cases. Among them, 277 cases were ablated under CT guidance, 121 cases under X-ray guidance, and unclear guidance method in the remaining 79 cases. West et al.[46] reported a case of T7 vertebral metastases of breast cancer treated with X-ray-guided microwave ablation combined with PVP. Postoperative spinal cord injury occurred, probably caused by bone cement leakage. Kastler et al.[32] performed CT-guided microwave ablation in 16 patients, but L3 and S1 nerve root injury occurred respectively in two patients after surgery. The main advantage of CT is clearly displaying the cross-section image, accurately locating the target lesion, and providing an image basis for protecting the vertebral foramen and intervertebral foramen, especially when the lesion is adjacent to the posterior cortex of the vertebral body.[16]
Clinical question 6: Can nerve electrophysiological monitoring be used to detect nerve damage in a real-time manner during percutaneous ablation?
Recommendation 6: Neurophysiological monitoring can be used during percutaneous microwave ablation, which may be helpful in preventing thermal injury (weak recommendation; evidence level: GPS).
Spinal cord injury is the most common and serious complication of all spinal surgeries. It can lead to permanent impairment of the patient's motor, sensory, and nerve reflex functions. The need for electrophysiological monitoring during percutaneous microwave ablation was evaluated by searching the above databases, and only one article was found out temporally. In this study treating 65 patients with spinal metastases with percutaneous microwave ablation combined with PVP, Deib et al.[17] used motor and somatosensory evoked potential monitoring for lesions very close to important nerve tissues. There was no nerve injury and good clinical results were achieved. At present, electrophysiological monitoring, which can detect in real-time nerve damage caused by stretching, ischemia, thermal coagulation, etc., is widely used in percutaneous radiofrequency ablation and cryoablation.[50],[51],[52] This guideline suggest that electrophysiological monitoring can be used during percutaneous microwave ablation, and may be helpful in preventing thermal injury.
Clinical question 7: How to effectively protect surrounding normal tissue during percutaneous microwave ablation?
Recommendation 7: Using a thermometer to measure temperature and low-temperature liquid isolation technology during percutaneous microwave ablation can timely detect and avoid to a certain extent high-temperature damage to the spinal cord, nerves, blood vessels, skin, and other soft tissues (strong recommendation; Evidence Level: D).
Microwave ablation may cause thermal damage to surrounding tissues, including the spinal cord and nerves. Generally, a temperature >44°C will cause irreversible damage to live tissues.[53],[54] Physicians have tried to measure the temperature at different points with a thermometer and use liquid isolation technology. Liquid isolation technology includes active and passive protection strategies.[55] By searching the above databases, a total of seven articles were included.[23],[32],[33],[34],[35],[37],[40] Among them, 72 cases used a thermometer. Thermometers were placed in the tumor center and the base of the pedicle near the posterior edge of the vertebral body in 48 cases. One case included liquid isolation, another took the skin ice pack to cool down for protection as the distance between the lesion and the skin was <3 cm. In cases where a thermometer was used, when the temperature is >42°C during microwave ablation, the alation was stopped immediately to avoid further damage. Khan et al.[35] treated metastases adjacent to the S1 nerve root choosing fluid isolation during ablation, but still had symptoms of nerve injury after surgery. Zhang et al.[41] reported two cases of skin infection complications, and Westbroek et al.[46] reported a case of spinal cord injury. Altogether, the use of a thermometer for temperature measurement and liquid isolation in percutaneous microwave ablation can early detect and avoid secondary injuries, which has clinical importance.
Clinical Question 8: How to choose ablation power and time in percutaneous microwave ablation for spinal metastases?
Recommendation 8: The recommended ablation power of percutaneous microwave ablation for spinal metastases is 20–80 W, and the time is 1–15 min (strong recommendation; evidence Level: D).
Selecting appropriate ablation power and time can improve the treatment result and reduce the accompanying complications to ablation. In the above databases, a total of 17 studies[15],[29],[31],[34],[35],[36],[37],[38],[39],[40],[41],[43],[44],[45],[46],[48],[49] specifically introduced the power and/or time of microwave ablation. Ke et al.[40] retrospectively summarized the data of 24 cases of percutaneous microwave ablation for spinal metastases. The ablation power was 66.40 ± 12.08 (range 40–80 W), and the ablation time was 3.99 ± 2.48 min. Postoperative pain was significantly relieved, and nerve function was normal. Kastler et al.[34] reported percutaneous microwave ablation of spinal metastases in 17 patients with a total of 20 lesions. The ablation power ranged between 30 and 70 W (average 60 W); the ablation time was 4.4 ± 2.7 min and each lesion was ablated with an average of 3.8 cycles. Pain was significantly relieved except for one patient. The effect lasted >6 months, and no serious complications occurred in any cases. Pusceddu et al.[39] used microwave ablation to treat spinal metastases and used a single needle in tumors with a maximum diameter <3.5 cm. The ablation time was 7 ± 5 min, and the power 50 ± 20 W. After complete metastases ablation, treatment results were good. In summary, the power and time selection during percutaneous microwave ablation should refer to the specific working parameters of the equipment to be used, and comprehensively evaluate factors such as the size, scope, the nature of the metastases, and real-time temperature monitoring of the surrounding spinal cord and nerves.
Clinical question 9: What are the complications of percutaneous microwave ablation for spinal metastases and how to avoid them?
Recommendation 9: Postoperative complications of percutaneous microwave ablation for spinal metastases include spinal cord, nerve root, skin, and soft tissue injuries. The application of microwave ablation in the treatment of spinal metastases needs to strictly follow the indications. It is recommended to use short-term, multi-cycle ablation under temperature monitoring to reduce the risk of complications (weak recommendation; evidence Level: D).
To find out the characteristics, risks, and solutions of postoperative complications of percutaneous microwave ablation in spinal metastases, a total of 20 articles were selected.[15],[23],[30],[31],[32],[34],[35],[36],[37],[38],[39],[40],[41],[43],[44],[45],[46],[47],[48],[49] Postoperative complications occurred in six cases in 395 patients, including two nerve root injuries, one skin burn, two skin infections, and one spinal cord injury. The complication rate was 1.52% (6/395). In conclusion, percutaneous microwave ablation is a relatively safe method for the treatment of spinal metastases.
Solutions for the complications reported in the literature include: (1) shortening the duration of each microwave ablation, or a short-term, multi-cycle ablation strategy. Controlling the ablation range, avoiding excessive damage to important tissues[16],[32],[33],[34],[39],[56]; (2) controlling microwave ablation power[15],[23],[30],[32],[33],[34],[36],[37],[39],[40],[41],[42],[43],[44],[45],[46],[47],[48],[57]; (3) strict patient screening. This method is not suitable for patients with destruction of the posterior wall of the vertebral body, or when the tumor is too close to the nerve root or spinal cord.[15],[23],[30],[32],[33],[34],[36],[37],[39],[40],[41],[42],[43],[44],[45],[46],[47],[48],[57] Therefore, strictly following the indications, percutaneous microwave ablation is recommended for the treatment of spinal metastases.
Surgical indications and contraindications for open microwave ablation
Clinical question 10: Can open decompression combined with microwave ablation be used in spinal metastases with spinal cord compression or spinal axial instability?
Recommendation 10: Open decompression combined with microwave ablation can treat spinal metastases with spinal cord compression or spinal axial instability, and effectively improve pain relief, reduce bleeding, and tumor cell dissemination (strong recommendation; Evidence Level: D).
Patients with spinal metastases and spinal cord compression or axial instability are usually treated with open decompression combined with internal fixation. A total of 11 articles were included by searching the above databases.[7],[58],[59],[60],[61],[62],[63],[64],[65],[66] Liu et al.[58] retrospectively analyzed 23 patients with single-segment thoracic metastases from breast cancer with a preoperative Tokuhashi score >8 points. All patients were treated with open decompression and internal fixation combined with microwave ablation. Of those, 78.3% (18/23) had improved Karnofsky functional status score and all patients had improved Frankel grade after the intervention; only four patients had postoperative complications. Liu et al.[61] retrospectively analyzed 30 patients with lumbar spine metastases and compared the efficacy of posterior small incision microwave ablation, bone cementation, screw placement through the multifidus muscle space, and traditional open surgery. The results showed that the first method had the least intraoperative and postoperative blood loss and the lowest postoperative VAS scores.
To sum up, microwave ablation has the following effects in open decompression surgery: (1) providing a good hemostatic effect, (2) effective pain relief,[7],[58],[59],[60],[61],[63],[64],[65],[66],[67] (3) reducing the spread of tumor cells.[59],[64],[65],[66],[67] Therefore, open surgery with microwave ablation is recommended for patients with spinal metastases and spinal cord compression or spinal axial instability.
Clinical Question 11: What are the contraindications of open microwave ablation in spinal metastases?
Recommendation 11: Surgical contraindications of open microwave ablation in spinal metastases include: (1) Tokuhashi score <7 points before surgery, and estimated survival time <3 months; (2) acute or active infectious lesions in any part of the body without effective control; (3) comorbidity with severe liver, kidney, and other organ insufficiencies; (4) unable to tolerate surgery. If any one of the above is met, open microwave ablation is not recommended (strong recommendation; evidence Level: D).
The surgical trauma of open microwave ablation in spinal metastases is greater than with minimally invasive ablation. To clarify the contraindications of surgery, a total of seven articles were retrieved by searching the above databases.[7],[57],[59],[61],[62],[63],[64] These studies clarified the exclusion criteria for open microwave ablation of spinal metastases. In addition, patients without confirmed symptoms of nerve or spinal cord compression by imaging examination and those who received PVP in the past were also excluded.[7],[63] Therefore, compression severity and the general condition of patients with spinal metastases should be comprehensively evaluated before surgery. The indications and contraindications of the operation should be strictly controlled.
Surgical techniques related to open microwave ablation
Clinical question 12: How to choose ablation power and time during open microwave ablation in spinal metastases?
Recommendation 12: The recommended power of open microwave ablation in spinal metastases is 20–80 W, and the time is 5–30 min (strong recommendation; evidence Level: D).
The principle of microwave ablation is inducing coagulative necrosis of the target tissue by using the electromagnetic field of microwaves. The energy level is positively correlated with microwave ablation power and time. To standardize the power and time selection for open microwave ablation of spinal metastases, a total of 11 articles were included by searching the above databases.[7],[57],[58],[59],[60],[61],[62],[63],[64],[65],[66] Cheng et al.[63] reported 20 patients who underwent percutaneous internal fixation with open decompression combined with microwave ablation for spinal metastases. Microwave power was set at 40–60 W; ablation time was 3–10 min in a total of 26 lesions. Nerve function and pain scores were significantly improved, and no microwave ablation related complications occurred. Li et al.[66] reported 20 patients who received microwave ablation combined with laminar decompression and internal fixation in the treatment of spinal metastases. The microwave power was set to 50 W, the ablation time was >10 min. The temperature around the spinal canal was monitored and controlled <42°C, and the frontal body temperature <50°C. Liu et al.[60] reported 23 cases of breast cancer with thoracic metastases who received a small incision combined with open microwave ablation. The microwave ablation power was 40–45 W, and the time 15–30 min. Good postoperative results were obtained in this case. Some articles[57],[61],[62] did not refer to ablation power and time, only monitored the temperature around the spinal cord, and set 42°C as the critical condition for ablation. In conclusion, the range of ablation power and time during open microwave ablation in spinal metastases should range between 20–80 W and 5–30 min. The real-time temperature around the spinal cord should be monitored and controlled within 42°C.
Clinical question 13: How to protect surrounding normal tissues during open ablation of spinal metastases effectively?
Recommendation 13: During open ablation of spinal metastases, reasonable monitoring of microwave antenna arrangement, thermometer needle application, and adequate cooling can reduce the damage to surrounding tissues (strong recommendation; evidence Level: D).
During open ablation of spinal metastases, protecting surrounding normal tissues is crucial to reduce postoperative complications. A total of 11 articles were included.[7],[57],[58],[59],[60],[61],[62],[63],[64],[65],[66] Ten of the studies[7],[57][58],[59],[61],[62],[63],[64],[65],[66] reported the application of thermometer needles and ice-salt water to cool down during ablation. Only one study used thermometer needles alone.[60] The arrangement of thermometer needles aims to protect the spinal cord and nerve tissue to the greatest extent. The thermometer needle was placed at the posterior border of the vertebral body (anterior to the spinal canal) in 326 patients, in the center of the vertebral body or tumor center in 111 patients, and adjacent to the pleura in 14 patients. A total of 314 patients were treated with iced saline to reduce spinal cord temperature during ablation; no spinal cord or nerve injury occurred in all cases. In conclusion, using iced saline for cooling and temperature monitoring with a thermometer during open ablation can effectively protect surrounding normal tissues.
Complications related to open microwave ablation
Clinical question 14: What are the postoperative complications of open microwave ablation in spinal metastases and how to treat the complications?
Recommendation 14: Postoperative complications of open microwave ablation for spinal metastases include thermal injury of nerve tissue, cerebrospinal fluid leakage, and delayed wound healing. It is recommended to perform strict temperature detection and effective ice water cooling around the lesion during intervention, reduce microwave duration, perform daily postoperative wound care, and perform vertebroplasty with or without combined internal fixation according to bone quality (strong recommendation; evidence Grade: D).
A total of 11 articles about the complications of open microwave ablation in spinal metastases were included by searching the above databases.[7],[57],[58],[59],[60],[61],[62],[63],[64],[65],[66] Ji et al.[7] reported lower limb muscle weakness and transient neuralgia after open ablation, which might be caused by excessive nerve tension during the intervention. Liu et al.[58] reported postoperative cerebrospinal fluid leakage in some patients. Chen et al.[64] reported delayed wound healing. Most articles (7/11) suggest strict temperature detection and effective ice water cooling should around the lesion. The most effective methods for delayed wound healing are reducing the duration of microwave ablation and postoperative wound care. For postoperative cerebrospinal fluid leakage, head-down position, and local compression can improve the symptoms. Li et al.[68],[69] believed that PVP combined with internal fixation could be feasible if the bone defect occurred after microwave ablation.
Microwave-related equipment
Clinical question 15: What kind of microwave antenna (microwave thermocoagulation ablation needles) is used for microwave ablation of spinal metastases?
Recommendation 15: The frequency of microwave instruments used in the medical field should be 2450 MHz. For percutaneous treatment, the puncture path is long, and a microwave needle with a diameter between 1.2–2.2 mm and a length of 180–210 mm is recommended. For open ablation, the operative field is wide, and a microwave needle with a diameter of 2.0–3.2 mm and a length of 150–210 mm can be selected (strong recommendation; evidence Level: D).
A total of 15 articles were included by searching the above databases.[7],[30], [31,[33],[34],[35],[36],[39],[40],[41],[44],[45],[46],[48],[49] Microwave instruments had a frequency of 2450 MHz in all articles. Microwave needles with a diameter between 1.2–2.2 mm and a length between 180–210 mm were used in 411 patients who received percutaneous microwave ablation, and needles with a diameter of 2.0–3.2 mm and a length of 150–210 mm were used in 38 patients who received open ablation.
> Formulation of GuidelinesFormulating methods
This guideline was developed in accordance with the concept and process framework of the American Institution of Medicine, the Appraisal of Guidelines Research and Evaluation II (AGREEII), and the WHO guideline development manual. The reporting process of guidelines follows the Reporting Item for Practice Guidelines in Healthcare (RIGHT).
Guide users and target audiences
Guideline users: orthopedic oncologists, interventional physicians, pain physicians, nurses, etc., Target audiences: Patients with spinal metastases and painful symptoms.
Statement of conflict of Interest
All members involved in the development of the guideline have declared any interest in this guideline and have completed a form of declaration of interest.
Clinical problem reconstruction and evidence retrieval
The included clinical questions were reconstructed according to the population, intervention, control, outcome indicators, study type principles. Evidence retrieval based on reconstructed clinical questions: (1) retrieval databases included: PubMed, Web of Science, Embase, CNKI, and Wanfang database; (2) research type: Priority search for published systematic reviews, meta-analyses, and randomized controlled trials within five years. For insufficient new evidence or low level of evidence, we searched for systematic reviews, meta-analyses, randomized controlled trials, cohort studies, case-control studies, etc., published for >5 years; (3) the retrieval time included from database establishment to June 1, 2021; (4) further search for recently published evidence before drafting of the guideline, until June 20, 2021.
Evidence quality evaluation and development of recommendations
The Assessing Methodological Quality of Systematic Reviews (AMSTAR) was used for methodological quality evaluation in systematic reviews and meta-analyses.[70] The Cochrane Risk of Bias Assessment Tool[71] was used for randomized controlled trials evaluation. The Newcastle– Ottawa Scale was used for observational studies.[72] This guideline adopts the Grading of Recommendations Assessment, Development and Evaluation (GRADE) for the evaluation of grading the quality of evidence and recommendation strength.[73] The meanings of the GRADE quality of evidence and strength of recommendation classifications are shown in [Table 1] and [Table 2], respectively. The guideline recommendations are simplified and displayed in the form of a table [Table 3] to facilitate the communication and application of the guideline. This guideline has been registered on the International Practice Guideline Registration Platform (IP-GRP-2021CN335). It started on April 4, 2020 and finalized on December 26, 2021.
Table 1: Grades and definitions of quality of evidence covered in this guidelineTable 2: Recommended intensity classifications and definitions covered in this guidelineTable 3: List of recommendations for clinical questions of microwave ablation in spinal metastasesAcknowledgments
The authors express gratitude to the experts who participated in the guideline development. The experts including Bingyao Chen (Aerospace Center Hospital), Guofen Chen (Southern Medical University Southern Hospital), Yantao Chen (Sun Yat-sen Memorial Hospital), Bin Fang (The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine), Hongbo He (Central South University Xiangya Hospital), Duan Hong (West China Hospital), Jun Hu (The First Affiliated Hospital of Shantou University School of Medicine), Zusheng He (Hong Kong University Shenzhen Hospital), Junmei Jia (The First Affiliated Hospital of Shanxi Medical University), Renbing Jiang (Xinjiang Medical University Cancer Hospital), Hucheng Liu (The First Affiliated Hospital of Nanchang University), Haomiao Li (The Third Affiliated Hospital of Southern Medical University), Lijun Lin (Southern Medical University Zhujiang Hospital), Tielong Liu (Shanghai Changzheng Hospital), Xiangdong Li (Xijing Hospital), Jianmin Song (Gansu Provincial People's Hospital), Guanning Shang (Shengjing Hospital Affiliated to China Medical University), Zhiqiang Tao (Nan Chang Hong Du TCM Hospital), Dong Wang (Cancer Hospital Affiliated to Guizhou Medical University), Jin Wang (Cancer Hospital Affiliated to Sun Yat-Sen University), Jin Xiao (Guangdong Provincial People's Hospital), Xing Wei (Aerospace Center Hospital), Yanbin Xiao (Yunnan Cancer Hospital), Junqiang Yin (The First Affiliated Hospital of Sun Yat-sen University), Xiuchun Yu (The 960th Hospital of the Joint Logistics Support Force of the PLA), Weitao Yao (Zhengzhou University Affiliated Cancer Hospital), Baorang Zhu (The Fifth Medical Center of the PLA General Hospital), Chunlin Zhang (Shanghai 10th People's Hospital), Guochuan Zhang (The Third Hospital of Hebei Medical University), Shiquan Zhang (The First Affiliated Hospital of Shenzhen University), Qing Zhang (Beijing Jishuitan Hospital), and Yong Zhou (Tangdu Hospital), had face-to-face discussions and determined the 15 recommendations. The experts including Xuequan Huang (Southwest Hospital), Xiaodong Tang (Peking University People's Hospital), Shaonian Xu (Liaoning Provincial
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