Committee of Minimally Invasive Therapy in Oncology, Chinese Anti-Cancer Association; Chinese College of Interventionalist; Expert Committee on Interventional Therapy, Chinese Society of Clinical Oncology (CSCO); Chinese Society of Radiology, Interventional Group; GAO Song1, ZHU Xu1*, ZOU Yinghua2*
(1. Department of Interventional Therapy, Peking University Cancer Hospital and Institute, Key Laboratory of Carcinogenesis and Translational Research [Ministry of Education], Beijing 100142, China;
2. Department of Interventional Vascular Surgery, Peking University First Hospital, Beijing 100034, China)
[Abstract] With the development of modern medical technology, the treatments of tumor are becoming more and more diverse. Cryoablation has been widely accepted because of its exact curative effect, less complications, less surgical trauma and rapid recovery. The multi-modal cold and hot combinated ablation (co-ablation) treatment with multi-modal is the first to put forward the multi-modal treatment mode of deep hypothermia and high-intensity heating broken the long-term monopoly situation of imported products and is unanimously affirmed by clinical experts. The interventional radiologist, physician and surgeon experts who were engaged in treatment of malignant tumor ablation had discussed the treatment standard of co-ablation for malignant tumor of lung fully and deeply, and reached the consensus of expert.
[Keywords] lung neoplasms; multi-modal ablation; clinical practice; expert consensus
DOI: 10.13929/j.issn.1672-8475.2020.12.001
[CLC No.] | R734.2; R815 | [Document code] | A | [Article No.] | 1672-8475(2020)12-0705-06 |
[Fund Program] National Key R&D Program (2017YFC0114004) and Beijing Municipal Science & Technology Commission Key R&D Program (Z181100010118001).
[Written by] Gao Song (1976-), male, from Dezhou, Shandong Province, doctor, chief physician. Research direction: imaging medicine and nuclear medicine (interventional therapy). E-mail: drgaosong@163.com
[Corresponding author] Zhu Xu, Department of Interventional Therapy, Peking University Cancer Hospital and Institute, Key Laboratory of Carcinogenesis and Translational Research [Ministry of Education], 100142.
E-mail: drzhuxu@163.com
Zou Yinghua, Department of Interventional Vascular Surgery, Peking University First Hospital, 100034. E-mail: 13801105222@139.com
[Received on] November 21, 2020
[Revised on] November 26, 2020
The report “2018 Global Cancer Statistics” [1] shows that lung cancer has become the first cancer-related cause of death. The imaging-guided ablation for treatment of lung cancer and metastatic lung cancer has been recommended by many international and domestic clinical guidelines and consensus, and cryoablation is effective and safe in the treatment of pulmonary malignant tumor [2-6]. The recommended update of the National Comprehensive Cancer Network (NCCN) Guidelines for Non-small Cell Lung Cancer [7] and Colorectal Cancer [8-9] in 2020 promoted the further promotion and application of ablation treatment in clinical practice. Compared with radiofrequency and microwave ablation technologies, cryoablation not only has the advantages of real-time observation of tumor ablation boundary, pain relief and good multi-needle conformity, but also can stimulate anti-tumor immune response and further strengthen anti-tumor effect [10-11].
The co-ablation system has China’s independent intellectual property, which integrates deep cryoablation and high-intensity thermal ablation, and its core performance parameters have obvious advantages compared with similar international products [12-14]. Compared with the argon-helium cryoablation, the system has the following advantages: ① It uses liquid nitrogen as the refrigerant, which has low cost and is easy to obtain, so that the system is promoted in grassroots hospitals; ② it can reach a lower cooling temperature (-196°C) and has a higher efficiency in tumor ablation and necrosis; ③ it uses anhydrous ethanol as the heat medium and can be heated to 80°C after freezing, killing tumors more thoroughly. It can also ablate the puncture needle passage, prevent bleeding, and prevent tumor needle passage implantation and metastasis. In order to promote the standardization and normalization of co-ablation technology in the treatment of pulmonary malignant tumor, this expert consensus is formulated for reference with the participation of multidisciplinary experts organized by many hospitals and in combination with the actual clinical application.
The co-ablation system is the fourth generation of tumor low-temperature ablation device developed by Tsinghua University and Institute of Physical and Chemical Technology of Chinese Academy of Sciences, and it is also a brand-new generation of high-low temperature compound tumor ablation device with complete independent intellectual property.
The mechanism of tumor cell destruction by co-ablation system includes the following [15]: ① direct damage to cells, low temperature leading to the formation of ice crystals inside and outside cells, dehydration of cells due to osmotic pressure difference, and mechanical damage of cell membranes and organelles by ice crystals; freezing changes the properties of protein-affinity in tissues and cells, increases the thermal sensitivity, and increases the temperature rapidly in the subsequent heating process, completely destroying the tumor; in this process, the small thermal stress leads to the change of microstructure, and the large thermal stress further increases the mechanical damage during heating; ② seriously destroying tumor microvessels [16], damaging vascular endothelial cells at low temperature, causing microthrombosis and causing tumor ischemia and hypoxia; alternation of cold and heat leads to reperfusion injury, which increases vascular permeability, and aggravates endothelial injury and tumor ischemia and necrosis; ③ inducing immune response, producing cytokines and releasing tumor antigen after freezing, which is helpful to start immune response; hyperthermia can induce the release of a large number of heat shock protein 70 (HSP70), induce myeloid-derived suppressor cells (MDSC) to differentiate into mature dendritic cells, increase immune presentation and enhance the activation of effector T cells (CD4+T and CD8+T) [17]; the combination of cold and heat increases the infiltration of cytotoxic T lymphocyte (CTL) and induces immune cells to enter tumor fragments [18]; ④ inducing apoptosis; in the process of alternating cold and hot, the frozen edge causes sublethal damage to cells, which leads to apoptosis [17].
As a local tumor ablation technology, co-ablation treatment should follow the following principles: ① Before the treatment of pulmonary tumor, comprehensively evaluate the tumor and the patient’s condition, including the patient’s physical condition and tumor biological behavior characteristics; ② determine the specific treatment scheme, define the treatment purpose, properly select the treatment opportunity, determine the ablation path, and make the puncture plan and needle arrangement scheme; ③ in the process of ablation, guide and monitor with appropriate imaging methods, fix the treatment position, implement the treatment according to the plan, closely monitor the disease changes during treatment, and adjust the treatment parameters and treatment plan in time); ④ closely monitor the changes in patients’ condition after operation, and prevent and cure possible surgical complications and comorbidities in time; ⑤ implement comprehensive and individualized treatment and scientific follow-up according to the overall treatment scheme.
3.1 Indications: According to the specific situation of patients and the purpose of treatment, ablation methods are determined, which mainly include radical ablation and palliative ablation [19]. Indications include: ① primary lung cancer: peripheral lung lesions, the number of lesions ≤ 2, the maximum diameter of tumor ≤ 3 cm, and no metastasis in other parts; ② in the case of the diameter of pulmonary tumor lesion > 5 cm or the number of unilateral lung lesion ≥ 3, multi-needle combination and fractional ablation treatment can be selected, or as a part of comprehensive treatment; ③ single recurrent lesion after other local treatment; ④ oligometastasis of primary lung cancer after surgery or radiotherapy; ⑤ primary or metastatic lung cancer in one lung (absence of one lung due to various reasons); ⑥ metastatic lung cancer: when the primary lesion has been effectively treated or controlled, local ablation can be performed on the lung metastatic lesion; ⑦ palliative ablation is also feasible if the mass of central lung cancer is large and there is a good puncture path; ⑧ the score of physical condition from Eastern Cooperative Oncology Group (ECOG) is 0-2; ⑨ patients cannot tolerate surgical resection or refuse surgical resection; ⑩ expected survival time > 3 months.
3.2 Contraindications [20]: ① tumor complicated with infectious or radioactive inflammation and ipsilateral massive pleural effusion; ② severe pulmonary fibrosis and emphysema; ③ uncorrectable coagulation dysfunction; ④ severe dysfunction or cachexia of liver, kidney, heart, lung and brain; ⑤ patients with consciousness disturbance or inability to cooperate with treatment; ⑥ extensive extrapulmonary metastasis, and expected survival time < 3 months.
Usually, iodophor is used to disinfect the skin, and four sterile square towels are used to cover the disinfection area, and sterile drapes are covered to expose the operation site. Implement local layer-by-layer infiltration anesthesia with 1%-2% lidocaine, or general anesthesia, intravenous anesthesia, etc. according to the specific situation of the patient.
Preoperative preparations includes: ① improving a series of routine examinations, and performing cardiopulmonary function assessment if necessary; ② thoracic imaging examination, including chest enhanced CT scan, and PET/CT examination if necessary; patients with basic diseases should be supplemented with relevant examinations to evaluate the feasibility of ablation; ③ for primary lung cancer, percutaneous biopsy or fiberoptic bronchoscopy should be performed before ablation treatment to confirm the pathological diagnosis; for atypical metastases, biopsy is recommended before ablation treatment; for early lung cancer with ground glass opacity (GGO), it can be ablated before biopsy with the informed consent of patients and their families to avoid massive bleeding. ④ informing patients and their families about the operation process, operation risks, preventive measures, possible prognosis and alternative treatment schemes before operation, and signing an informed consent form; ⑤ for patients receiving anticoagulant therapy, anticoagulant drugs should be stopped in advance according to the requirements of corresponding drugs to reduce the risk of bleeding; ⑥ fasting and drinking 6 hours before operation, patients with hypertension can continue to take antihypertensive drugs; patients with obvious cough should be given oral antitussive drugs 1-2 h before operation; ⑦ establishing venous access and carrying out necessary breathing training and psychological counseling.
6.1 Selection and fixation of treatment position: Based on the stability of the position and patient tolerance, the treatment position can be determined by combining imaging data and patient condition, and can be in a supine, prone, or lateral position. It is recommended to use a vacuum negative pressure pad to help fix the position.
6.2 Operation positioning and needle arrangement scheme: ① Grating positioning can be used, and the grating can be pasted on the body surface. After scanning, the size and shape of the tumor and its relationship with adjacent organs can be evaluated by real-time CT images, and the puncture position, inserting depth and angle and number of ablation probes can be determined, and the corresponding puncture points can be marked; ② the liquid nitrogen is used as the refrigerant in co-ablation treatment, and the lowest temperature can reach -196°C, so the cooling capacity is large. According to the practical experience, after a single ablation probe with a diameter of 2.6 mm is used to puncture the center of lung lesions, the lesions with a diameter less than 3 cm can be completely ablated by freezing for 2 cycles, and a larger range of ice ball can be produced for 3 cycles [21-22]. Multi-needle implantation can be selected according to the size of the tumor during operation. In principle, the distance between 2 ablation probes is less than 2 cm, which can produce good synergy.
6.3 Coverage with routine ablation drape: A head rest can be used to support and fix the head, avoiding covering the mouth and nose and affecting breathing.
6.4 Ablation probe and device test: Under in vitro sterile conditions, the ablation probe treatment area is placed into a container filled with normal saline, and 3 cm above the probe tip is immersed in normal saline, and then the system’s low-temperature output function is performed. The recommended test time is 3 min. During the period, attention is paid to observing whether there is a trend of ice ball formation, whether there are continuous bubbles near the probe, and whether the ablation device is operating properly. In case of any problems, the ablation probe should be replaced or the ablation device should be adjusted in a timely manner.
6.5 Anesthesia: During local anesthesia, local infiltration anesthesia with 1% -2% lidocaine is applied to the marked puncture points layer by layer; systematic anesthesia is performed by an anesthesiologist. After anesthesia is satisfactory, the syringe needle can be left in the body surface position of the puncture point for CT scan, and it can be used as a marker for preliminary observation to simulate the inserting position and angle of ablation puncture needle.
6.6 Puncture and positioning: Single needle, double needle, or multiple needles can be selected based on the treatment purpose and ablation zone. According to the planning scheme, the ablation probe should be percutaneously punctured to the location of the lesion. When passing through the pleura, it should pass quickly and enter the visceral pleura for at least 3 cm. In the complete response plan, the tip of ablation probe should exceed the edge of the lesion by about 5 mm, and the cryoablation treatment should be started after being confirmed by CT or ultrasound examination.
6.7 Implementation of ablation treatment: The minimum temperature for cryoablation is -196°C, and the duration is generally 5-15 min; after each freezing, rewarming can be carried out using natural rewarming or heating, with a maximum temperature of 80°C and a general duration of 3-8 min. One freezing-thawing cycle includes one freezing and one rewarming, and generally, one to three freezing-thawing cycle(s) is (are) applied according to the lesion.
6.8 Intraoperative imaging monitoring: In the case of complete response, in principle, the ablation zone should strive to exceed the edge of the lesion by more than 5 mm. During ablation, CT scan or ultrasound examination is performed at intervals of 5-10 min according to the distance between the lesion boundary and adjacent organs to monitor the scope of cryotherapy and its relationship with adjacent tissues and organs, and the treatment parameters are adjusted in time if necessary. For large lesions, the imaging findings of the ice ball covering boundary and peripheral tissue exudation should be observed, while for small lesions, the peripheral tissue exudation and GGO range should be focused.
6.9 Withdrawal and removal of ablation probe: In the rewarming mode, the maximum temperature for co-ablation treatment can reach 80°C, and the probe can be gradually withdrawn or withdrawn step by step according to the conditions, and the puncture needle passage can be ablated as appropriate.
6.10 Bandaging puncture point: After treatment, the puncture point is disinfected and the sterile dressing is applied.
6.11 Immediate CT scan after treatment: Check for complications such as bleeding and pneumothorax, and treat them according to the situation.
6.12 Returning to the ward: After completing the above procedures, the medical staff accompany the patient back to the ward and provide post-treatment monitoring and other measures.
7.1 ECG monitoring: The multifunctional ECG monitor is used to monitor blood pressure, blood oxygen saturation, heart rate and electrocardiogram in real time, and closely monitor the changes of vital signs. Generally, they need monitoring for more than 12 h.
7.2 Observation of changes in patients’ condition: Pay attention to whether there is fever, hemoptysis, chest pain, difficulty breathing, pneumothorax, etc., and treat symptomatically according to the situation.
7.3 For high-risk patients, antibiotics can be given as appropriate to fight infection; if the patient has a severe cough, antitussive drugs can be used as appropriate.
7.4 Prevention and treatment of complications: Common complications are pneumothorax, bleeding and pleural effusion, while other complications are relatively rare.
7.4.1 Pneumothorax: It is a common complication after chest puncture [12], which can occur during or after operation. For patients with combined emphysema and pulmonary bulla, the number of punctures should be reduced as much as possible to reduce the risk of pneumothorax. When the lung tissue compression is less than 20%, pneumothorax can be completely absorbed after conservative treatment; patients with obvious symptoms are given oxygen inhalation, and closed thoracic drainage and anti-infection are performed when necessary. On day 1 after operation, patients are reexamined by chest X-ray to observe whether there is delayed pneumothorax.
7.4.2 Bleeding: In case of hemoptysis or blood in sputum during or immediately after operation, where appropriate, symptomatic hemostasis treatment and intervention measures may be taken according to the Expert Consensus on Perioperative Bleeding Prevention and Treatment in Thoracic Surgery [23].
7.4.3 Pleural effusion: Symptoms often include a small amount of hemothorax or reactive pleural effusion. A small amount of effusion can be absorbed by itself within 1 month. For moderate or large amounts of effusion, puncture and aspiration treatment is required.
7.4.4 Subcutaneous emphysema: It is more common in patients with emphysema and pulmonary bulla, and it can also be seen in those with emaciation complicated with subcutaneous connective tissue looseness. Generally, it can be absorbed by itself. Pneumothorax with subcutaneous emphysema should be treated according to the principle of pneumothorax treatment.
7.4.5 Pleural fistula: It is a rare complication that can occur in patients with large tumors, adjacent to the pleura, and difficulty in healing the pleura after multi-needle and multi-point puncture; it is often accompanied by hydropneumothorax, and if necessary, closed thoracic drainage should be performed.
7.4.6 Others: Clinical manifestations such as fever, chest pain, asthma, vomiting, transient hypertension, increased heart rate, hiccup caused by diaphragmatic spasm, hypothermia reaction (decreased blood pressure and increased heart rate) and cold shock (multiple systemic organ failure, severe coagulation abnormality and disseminated intravascular coagulation) can be treated symptomatically [24].
1 month after treatment, patients are reexamined by chest enhanced CT to evaluate the local treatment effect of ablation [25]. Evaluation criteria: ① complete response (CR): CT findings of arterial phase lesions without enhancement indicate complete tumor necrosis; ② incomplete response (ICR): CT findings of local enhancement within the arterial phase lesion indicate residual tumor, and further ablation treatment is feasible, followed by re-evaluation of the ablation effect; ③ local tumor progression: CT shows a new lesion appearing at the edge of the ablation lesion and connected to the ablation lesion; ④ new lesions: New lesions appear in other parts of the lung.
9.1 Follow-up contents ① pulmonary tumor: Lung enhanced CT and other examinations are performed to judge the blood supply of tumor in arterial phase; it is recommended to choose whether to carry out PET/CT examination at 3 months after operation according to the specific situation; ② general conditions: judge other tissues and organs through systematic examination, which usually includes imaging examination such as PET/CT, chest CT, brain MRI, isotope bone imaging and ultrasound, and serological detection such as tumor markers; ③ general conditions and organ functions of patients: evaluate the general conditions, including physical condition score (ECOG score or KPS score), quality of life score, pain score, etc. of patients; organ function related examinations include liver and kidney function, bleeding and coagulation function, etc.
9.2 Follow-up schedule: ① After radical ablation treatment, it is recommended that patients with primary lung cancer should be reexamined 1 month after operation and every 3 months within 2 years after operation to observe pulmonary tumors, tumor markers, patients’ general conditions and main organ functions; after 2 years, patients should be reexamined every 3-6 months to observe the pulmonary tumors, tumor markers, patients’ general conditions and main organ functions; after that, patients should be reexamined at an appropriate frequency according to the related symptoms and reexamination results. For patients with metastatic tumors, it is recommended to follow up regularly and systematically according to the guidelines for diagnosis and treatment of primary tumor, and follow up pulmonary tumors according to the follow-up scheme of primary lung cancer. ② After palliative ablation treatment, it is recommended to follow up the pulmonary tumors, tumor markers, patients’ general conditions and main organ functions 1 month after operation, and make a general examination if necessary; after that, regular follow-up is carried out according to the comprehensive treatment and individualized treatment scheme of tumor.
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(See next page for the list of editorial board members)
List of Editorial Board Members
Written by
Gao Song (Peking University Cancer Hospital), Wang Jian (Peking University First Hospital), Yang Wuwei (Fifth Medical Center of Chinese PLA General Hospital), Yu Haipeng (Tianjin Medical University Cancer Institute & Hospital) and Xing Wenge (Tianjin Medical University Cancer Institute & Hospital).
Responsible editorial board members
Wang Zhongmin (Ruijin Hospital Shanghai Jiao Tong University School of Medicine), Yan Zhiping (Zhongshan Hospital Fudan University), Cheng Yingsheng (Shanghai Tenth People’s Hospital), Zhu Xu (Peking University Cancer Hospital), Zhang Fujun (Sun Yat-sen University Cancer Center), Guo Zhi (Tianjin Medical University Cancer Institute & Hospital), Xiao Yueyong (First Medical Center of Chinese PLA General Hospital), Xu Ke (First Affiliated Hospital of China Medical University), Zou Yinghua (Peking University First Hospital) and Teng Gaojun (Zhongda Hospital Southeast University).
Editorial board members (sorted by Pinyin of surnames)
Cheng Yingsheng (Shanghai Tenth People’s Hospital), Duan Feng (First Medical Center of Chinese PLA General Hospital), Duan Liuxin (PLA Rocket Force Characteristic Medical Center), Fan Weijun (Sun Yat-sen University Cancer Center), Feng Huasong (Sixth Medical Center of PLA General Hospital), Feng Weijian (Fu Xing Hospital, Capital Medical University), Gao Song (Peking University Cancer Hospital), Gu Yuming (Affiliated Hospital of Xuzhou Medical University), Guo Jianhai (Peking University Cancer Hospital), Guo Zhi (Tianjin Medical University Cancer Institute & Hospital), Han Jianjun (Shandong Cancer Hospital), Hu Kaiwen (Dongfang Hospital Beijing University of Chinese Medicine), Huang Ming (Yunnan Cancer Hospital), Huang Jinhua (Sun Yat-sen University Cancer Center), Jin Long (Beijing Friendship Hospital, Capital Medical University), Li Huai (Cancer Hospital Chinese Academy of Medical Sciences), Li Xiao (Cancer Hospital Chinese Academy of Medical Sciences), Li Hailiang (Henan Cancer Hospital), Li Jiaping (First Affiliated Hospital Sun Yat-sen University), Li Quanwang (Dongfang Hospital Beijing University of Chinese Medicine), Li Wentao (Fudan University Shanghai Cancer Center), Li Xiaoguang (Beijing Hospital), Lin Hailan (Fujian Cancer Hospital), Liu Chen (Peking University Cancer Hospital), Liu Jing (Technical Institute of Physics and Chemistry, CAS), Liu Rong (Zhongshan Hospital Fudan University), Liu Ruibao (Harbin Medical University Cancer Hospital), Liu Yu’e (People’s Hospital of Shanxi Province), Ma Yilong (Cancer Hospital Affiliated to Guangxi Medical University), Mao Aiwu (Tongren Hospital Shanghai Jiao Tong University School of Medicine), Meng Zhiqiang (Fudan University Shanghai Cancer Center), Mou Wei (the Southwest Hospital of AMU), Ni Caifang (First Affiliated Hospital of Soochow University), Niu Lizhi (Guangzhou Fuda Cancer Hospital), Ren Weixin (First Affiliated Hospital of Xinjiang Medical University), Shao Guoliang (Fujian Cancer Hospital), Shao Haibo (First Hospital of China Medical University), Si Tongguo (Tianjin Medical University Cancer Institute & Hospital), Song Li (Peking University First Hospital), Su Hongying (First Hospital of China Medical University), Sun Junhui (First Affiliated Hospital, Zhejiang University), Tang Jun (Shandong Medical Imaging Research Institute), Teng Gaojun (Zhongda Hospital Southeast University), Wang Jian (Peking University First Hospital), Wang Weidong (First Medical Center of Chinese PLA General Hospital), Wang Zhongmin (Ruijin Hospital Shanghai Jiao Tong University School of Medicine), Wu Gang (First Affiliated Hospital of Zhengzhou University), Xiao Yueyong (First Medical Center of Chinese PLA General Hospital), Xing Wenge (Tianjin Medical University Cancer Institute & Hospital), Xiong Bin (Union Hospital, Tongji Medical College, Huazhong University of Science and Technology), Xu Ke (First Hospital of China Medical University), Xu Linfeng (Sun Yat-sen Memorial Hospital of Sun Yat-sen University), Yan Dong (Beijing Luhe Hospital Capital Medical University), Yan Zhiping (Zhongshan Hospital Fudan University), Yang Ning (Peking Union Medical College Hospital), Yang Jijin (Changhai Hospital, Naval Medical University), Yang Renjie (Peking University Cancer Hospital), Yang Weizhu (Fujian Medical University Union Hospital), Yang Wuwei (Fifth Medical Center of Chinese PLA General Hospital), Yang Yefa (Shanghai Oriental Hepatobiliary Surgery Hospital), Yang Zhengqiang (Cancer Hospital Chinese Academy of Medical Sciences), Ye Xin (Shandong Provincial Hospital), Yin Guowen (Jiangsu Cancer Hospital), Yu Changlu (Tianjin Third Central Hospital), Yu Haipeng (Tianjin Medical University Cancer Institute & Hospital), Yu Youtao (Fourth Medical Center of Chinese PLA General Hospital), Zhai Bo (Renji Hospital Shanghai Jiao Tong University School of Medicine), Zhang Lin (Beijing Tsinghua Changgung Hospital), Zhang Jing (Guangzhou Women and Children Medical Center), Zhang Fujun (Sun Yat-sen University Cancer Center), Zhang Yuewei (Beijing Tsinghua Changgung Hospital), Zhao Jianbo (Southern Medical University), Zheng Chuansheng (Union Hospital, Tongji Medical College, Huazhong University of Science and Technology), Zheng Jiasheng (Beijing Youan Hospital Capital Medical University), Zhou Shi (Affiliated Hospital of Guizhou Medical University), Zhou Chengzhi (First Affiliated Hospital of Guangzhou Medical University), Zhu Xu (Peking University Cancer Hospital) and Zou Yinghua (Peking University First Hospital).
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