Committee of Minimally Invasive Therapy in Oncology, Chinese Anti-Cancer Association; Chinese College of Interventionalists; Expert Committee on Interventional Therapy, Chinese Society of finical 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; 2. Department of Interventional Vascular Surgery, Peking University First Hospital, Beijing 100034)
[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 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; Muli-modal ablation; Clinical practice; Expert consensus
[CLC] R734. 2; R815 [Document code] A [Article number] 1672-8475(2020)12-0705-06
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[Fund project] National key R&D plan project (2017YFC0114004), key R&D plan project of Beijing Municipal Science & Technology Commission (Z191100010118001).
[Author] Gao Song (1976-), male, from Dezhou, Shandong, PhD, chief physician. Research direction: imaging 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 date] 2020-11-21 [Revised date] 2020-11-26
According to the "2018 Global Cancer Statistics" report[1], lung cancer has become the leading cause of cancer-related deaths. Image-guided ablation therapy for lung cancer and metastatic lung cancer has been recommended by multiple international and domestic clinical guidelines and consensus. Among them, cryoablation therapy has been proven to be effective and safe for the treatment of malignant lung tumors[2-6]. The updated guidelines from the National Comprehensive Cancer Network (NCCN) in 2020 for non-small cell lung cancer[7] and colorectal cancer[8-9] shall promote further clinical application and dissemination of ablative therapies. Compared to other ablative techniques such as radiofrequency and microwave, cryoablation not only offers advantages like real-time observation of tumor ablation margins, pain relief, and better multi-needle conformability, but also stimulates anti-tumor immune response, thereby further enhancing its anti-tumor effect[10-11].
The cold and hot multi-modal ablation system (co-ablation system) has independent intellectual property rights in China and integrates deep hypothermia and high-intensity heating ablation. Compared to similar international products, it has significant advantages in terms of core performance parameters[12-14]. Compared to simple cryoablation techniques, this system has the following advantages: 1) it uses liquid nitrogen as the coolant, which is cost-effective, easily accessible, and suitable for promotion in primary hospitals; 2) it can achieve even lower cooling temperatures (-196℃), resulting in higher efficiency of tumor ablation and necrosis; 3) it uses anhydrous ethanol as the heating medium, allowing post-cryoablation heating up to 80℃, leading to more thorough tumor eradication. It can also ablate the needle pathway, prevent bleeding, and prevent the tumor needle tract implantation and metastasis. In order to promote the standardization and normalization of cold and hot multi-modal ablation technology for the treatment of malignant lung tumors, this expert consensus was developed for reference after the participation of multidisciplinary experts organized by a number of hospitals and combined with the actual clinical application.
The cold and hot multi-modal ablation system is the 4th generation tumor cryoablation device developed by Tsinghua University and Technical Institute of Physics and Chemistry, CAS. It is a new generation of high-low temperature composite tumor ablation device with complete independent intellectual property rights originating in China.
The mechanisms by which cold and hot multi-modal ablation destroys tumor cells include the following[15]: ① direct cell damage: low temperatures lead to the formation of ice crystals inside and outside the cells, causing osmotic imbalance and cellular dehydration. Ice crystals mechanically damage the cell membrane and organelles. Freezing alters the nature of intracellular proteins, increasing thermal sensitivity. Rapid heating during subsequent phases thoroughly destroys the tumor. During this process, minor thermal stress leads to microscopic structural changes, while greater thermal stress during heating further increases mechanical damage; ② it severely damages tumor microvessels[16]. Low temperatures cause injury to the endothelial cells of blood vessels, leading to the formation of microthrombi and resulting in tumor ischemia and hypoxia. The alternation of cold and hot temperatures causes reperfusion injury, increasing vascular permeability and exacerbating endothelial damage and tumor ischemic necrosis; ③ induction of immune response: after freezing, the production of cytokines and release of tumor antigens help initiate an immune response. Hyperthermia can induce the release of a large amount of heat shock protein 70 (HSP70), which promotes the differentiation of myeloid-derived suppressor cells (MDSCs) into mature dendritic cells, enhancing immune presentation and activating effector T cells (CD4+ T and CD8+ T cells)[17]. The combination of cold and hot treatments increases the infiltration of cytotoxic T lymphocytes (CTL) and induces immune cells to enter tumor fragments[18]; ④ induction of cell apoptosis: during the process of cold-hot alternation, the freezing edge causes sublethal damage to cells, leading to cell apoptosis[17].
As a local tumor ablation technique, cold and hot multi-modal ablation therapy shall follow the following principles: ① before treating lung tumors, a comprehensive evaluation of the tumor and patient's condition shall be conducted, including assessing the patient's physical condition and the biological behavior characteristics of the tumor; ② determine the specific treatment plan, clarify the treatment objectives, select the appropriate treatment timing, determine the ablation pathway, and develop a puncture plan and needle placement strategy; ③ during the ablation process, guide and monitor using appropriate imaging methods, immobilize the patient in the treatment position, implement the treatment according to the plan, closely monitor changes in the patient's condition during the treatment process, and make timely adjustments to the treatment parameters and disposal plan; ④ postoperatively, closely monitor changes in the patient's condition and promptly prevent and treat potential surgical complications and comorbidities; ⑤ implement comprehensive, individualized treatment and scientific follow-up based on the overall treatment plan.
3.1 Indications: the ablation modality is decided according to the patient's specific situation and therapeutic purpose, which mainly includes 2 methods: radical ablation and palliative ablation[19]. The indications include: ① primary lung cancer with pulmonary peripheral lesions ≤2 lesions, maximum tumor diameter ≤3cm, and no other site metastasis; ② for lung tumors with a diameter >5cm or ≥3 unilateral lung lesions, multi-needle combination and sequential ablation therapy may be chosen or used as a part of comprehensive treatment; ③ solitary recurrent lesions after other local treatments; ④oligometastasis in the lung after primary lung cancer surgical or radiation therapy; ⑤ primary or metastatic lung cancer in a single lung (leading to lung lobectomy due to various causes); ⑥ for metastatic lung cancer, when the primary lesion has been effectively treated or controlled, local ablation can be performed on the pulmonary metastatic lesions; ⑦palliative ablation can also be performed if there is a large centrally located lung cancer mass with a good puncture pathway; ⑧ Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; ⑨ patients who are unable to tolerate or refuse surgical resection; ⑩ estimated survival period >3 months.
3.2 Contraindications[20]: ① tumors accompanied by infectious or radiation-induced inflammation and large amounts of ipsilateral pleural effusion; ② severe pulmonary fibrosis and emphysema; ③ irreversible coagulation dysfunction; ④ severe impairment of liver, kidney, heart, lung, or brain function, or cachexia; ⑤ patients with impaired consciousness or unable to cooperate with treatment; ⑥ extensive extrapulmonary metastasis with an estimated survival period ＜ 3 months.
Typically, iodine is used to disinfect the skin. Four sterile towels are used to cover the disinfection area, and a sterile fenestrated drape is placed on top to expose the operative site. Local infiltration anesthesia with 1% to 2% lidocaine is used layer by layer, or general anesthesia or intravenous anesthesia may be used based on the specific condition of the patient.
Preoperative preparations include: ① completing a series of routine examinations and conducting cardiovascular and pulmonary function assessments if necessary;② chest imaging examinations, including enhanced CT scanning, shall be performed within 2 weeks, and PET/CT examination shall be conducted if necessary; additional relevant examinations shall be conducted for patients with underlying diseases to assess the feasibility of ablation; ③ for primary lung cancer, percutaneous puncture biopsy or bronchoscopy examination shall be performed before ablation treatment to confirm the pathological diagnosis; biopsy is recommended for atypical metastatic lesions before ablation treatment; for early-stage lung cancer with imaging features of ground glass opacity (GGO), ablation can be performed before biopsy with the consent of the patient and family members to avoid excessive bleeding; ④ informing the patient and family members about the surgical process, surgical risks and preventive measures, potential prognosis, and alternative treatment options; as well as signing an informed consent form; ⑤ patients receiving anticoagulant therapy shall discontinue the medication in advance according to the requirements of the corresponding drugs to reduce the risk of bleeding; ⑥ fasting for 6 hours before surgery, no water intake. Hypertensive patients can continue to take antihypertensive medications; patients with significant cough shall be given oral antitussive medication 1-2 hours before surgery; ⑦ establishing intravenous access and conducting necessary respiratory training and psychological counseling.
6.1 Treatment position selection and fixation: based on the position stability and patient tolerance, the treatment position shall be determined by comprehensively considering image data and patient conditions. The supine position, prone position or lateral position can be used. It is recommended to use a vacuum negative pressure pad to help immobilize the position.
6.2 Operation positioning and needle placement plan:
① grid positioning can be used by attaching a grid to the body surface. After scanning, the tumor size, shape, and its relationship with adjacent organs can be evaluated using real-time CT images. The puncture position, depth, angle, and number of ablation probes can be determined, and corresponding puncture points can be marked; ② cold and hot multi-modal ablation uses liquid nitrogen as the coolant, with the lowest temperature reaching -196°C. It provides a large cooling capacity. According to practical operational experience, a single 2.6mm diameter ablation probe can be inserted into the center of the lung lesion, and freezing it for 2 cycles can completely ablate lesions with a diameter smaller than 3cm. 3 cycles can generate a larger range of ice balls.[21-22]. During the surgery, multiple needles can be placed according to the tumor size. In principle, the distance between two ablation probes shall be less than 2cm to achieve better synergy.
6.3 Conventional ablation draping: a headrest can be used to support and fix the head, avoiding the obstruction of the nose and mouth to ensure proper breathing.
6.4 Testing ablation probe and device: under in vitro aseptic conditions, the ablation probe treatment area is placed in a container filled with normal saline. 3cm above the needle tip is immersed in the normal saline. Then, the system's low-temperature output function is activated as routine. It is recommended to test for a duration of 3 minutes. During the process, pay attention to whether there is a trend of ice ball formation, the presence of continuous bubbles near the probe, and the proper functioning of the ablation device. If any issues are found, promptly replace the ablation probe or adjust the ablation device accordingly.
6.5 Anesthesia: during local anesthesia, the marked puncture site is anesthetized by infiltrating with 1% to 2% lidocaine locally layer by layer; for general anesthesia, it is performed by an anesthesiologist. After satisfactory anesthesia, the syringe needle can be left in place at the surface of the puncture site for CT scanning. It serves as a marker for preliminary observation and simulates the position and angle of the ablation needle during the puncture.
6.6 Puncture and localization: single, double or multiple needles can be used depending on the treatment objectives and the range of ablation. According to the planned scheme, the ablation probe shall be punctured percutaneously to the lesion. When passing through the pleura, it shall pass quickly and enter the visceral pleura for more than 3cm. In the complete ablation plan, the tip of the ablation probe shall be about 5mm beyond the lesion edge, and cryoablation shall be started after confirmation by CT or ultrasound.
6.7 Implementation of ablation treatment: the minimum temperature for cryoablation is -196°C, and the duration is typically 5 to 15 minutes; after each freezing cycle, the rewarming follows, which can be done naturally or through heating, with temperatures reaching up to 80°C, and the duration typically ranging from 3 to 8 minutes. One cycle of freezing and thawing consists of one freeze and one rewarming, and generally one to three cycle of freezing and thawing are applied depending on the lesion.
6.8 Intraoperative image monitoring: during complete ablation, the goal is to ensure that the ablation zone extends at least 5mm beyond the lesion edge. During the ablation process, CT scans or ultrasound examinations shall be performed at intervals of 5 to 10 minutes based on the distance between the lesion boundary and adjacent organs. Monitor the extent of the freezing treatment and its relationship with surrounding organs and tissues. If necessary, treatment parameters shall be adjusted promptly. For large lesions, attention shall be paid to the imaging features of the ice ball covering the lesion boundary and the surrounding tissue exudation. For small lesions, the focus shall mainly be on the surrounding tissue exudation and GGO range.
6.9 Retraction and removal of ablation probe: during the rewarming phase, the maximum temperature of cold and hot multi-modal ablation treatment can reach 80°C. The retraction of the probe shall be performed gradually or in steps based on the condition. The ablation of the puncture needle channel shall be conducted as deemed necessary.
6.10 Dressing for puncture site: after the treatment is completed, disinfect the puncture site and apply sterile dressing.
6.11 After completing the treatment, perform an immediate CT scan to check for complications such as bleeding, pneumothorax, and handle them accordingly based on the situation.
6.12 Transfer to the ward: after completing the above procedures, medical staff shall accompany the patient back to the ward and provide post-treatment monitoring and other necessary care.
7.1 ECG monitoring: a multi-functional ECG monitor is used to monitor real-time blood pressure, blood oxygen saturation, heart rate, and ECG, closely monitoring changes in vital signs. Generally, monitoring is required for more than 12 hours.
7.2 Observation of changes in condition: pay attention to the presence of fever, hemoptysis, chest pain, dyspnea, pneumothorax, etc., and handle them accordingly based on the situation.
7.3 For high-risk patients, antibiotics may be administered as needed for infection control; if the patient has severe coughing, cough suppressants may be used as appropriate.
7.4 Prevention and treatment of complications: common complications include pneumothorax, bleeding, and pleural effusion, while other complications are relatively rare.
7.4.1 Pneumothorax: it is a common complication after thoracentesis and can occur intraoperatively or postoperatively. For patients with concomitant pulmonary emphysema and bullae, attempts shall be made to minimize the number of punctures in order to reduce the risk of pneumothorax. When lung tissue compression is less than 20%, pneumothorax can be completely absorbed through conservative treatment; oxygen therapy shall be given to patients with obvious symptoms, and if necessary, closed chest drainage and anti-infection may also be performed. Chest X-ray shall be conducted for reexamination on the first day after the surgery to observe for delayed pneumothorax.
7.4.2 Bleeding: if hemoptysis or blood-tinged sputum occurs immediately during or after the surgery, appropriate treatment for hemostasis shall be administered. Intervention measures can be taken according to the Expert Consensus on Prevention and Management of Perioperative Bleeding in Thoracic Surgery[23].
7.4.3 Pleural effusion: it is often characterized by small amounts of blood or reactive effusion. Small amounts of effusion is mostly self-absorbed within one month. Moderate to large amounts of effusion may require thoracentesis.
7.4.4 Subcutaneous emphysema: it is commonly seen in patients with pulmonary emphysema and bullae, as well as in individuals with a lean body type and loose subcutaneous connective tissue. In general, it can be absorbed naturally. When subcutaneous emphysema occurs in conjunction with pneumothorax, it shall be managed according to the principles of pneumothorax treatment.
7.4.5 Pleural fistula: it is a rare complication that occurs in cases where there is a large tumor adjacent to the pleura and the pleura is difficult to heal after multiple needle punctures; it is often associated with hydropneumothorax, and in necessary cases, closed thoracic drainage shall be performed for management.
7.4.6 Others: for clinical symptoms such as fever, chest pain, asthma, vomiting, transient hypotension, increased heart rate, diaphragmatic spasms causing hiccups, hypothermic reactions (decreased blood pressure, increased heart rate), and cold shock (multiple organ dysfunction, severe coagulation abnormalities, disseminated intravascular coagulation), symptomatic treatment shall be administered[24].
One month after treatment, a chest enhanced CT scan shall be re-examined to evaluate the efficacy of local ablation therapy[25]. Evaluation criteria: ① complete response (CR): CT scan shows no lesion enhancement in the arterial phase, indicating complete tumor necrosis; ② incomplete response (ICR): CT scan shows local lesion enhancement within the arterial phase, indicating residual tumor; repeat ablation therapy can be performed, and the ablation efficacy shall be reassessed afterwards; ③ local tumor progression: CT scan shows the appearance of new lesions at the edge of the ablation zone and connected to the ablated area; ④ new lesion: newly developed lesions in other areas of the lungs.
9.1 Follow-up contents: ① lung tumor situation: perform lung enhanced CT and other examinations to assess the tumor blood supply in the arterial phase. PET/CT examination may be considered 3 months after surgery based on specific circumstances; ② general condition: assess the condition of other organs through systematic examinations, typically including PET/CT, chest CT, cranial MRI, isotope bone scintigraphy, ultrasound, and tumor markers; ③ patient's general condition and organ function: evaluate the general condition, including patient's physical status score (ECOG or KPS score), quality of life score, pain score, etc.; organ function-related examinations include liver and kidney function, coagulation function, etc.
9.2 Follow-up schedule: ① after curative ablation treatment, it is recommended to conduct follow-up examinations for patients with primary lung cancer at 1 month and every 3 months within the first 2 years after surgery. These examinations shall observe the lung tumors, tumor markers, general condition of the patient, and major organ functions; after 2 years, follow-up examinations shall be conducted every 3 to 6 months to observe the lung tumor status, tumor markers, general condition of the patient, and major organ functions; subsequently, the frequency of follow-up examinations shall be determined based on relevant symptoms and examination results. For patients with metastatic tumors, it is recommended to conduct regular systematic follow-up based on the guidelines for the diagnosis and treatment of the primary tumor. The lung tumors can be followed up with reference to the primary tumor follow-up protocol. ② After palliative ablation treatment, it is recommended to perform a follow-up examination at 1 month post-surgery to assess the lung tumor status, tumor markers, general condition of the patient, and major organ functions. A whole-body examination may be necessary; subsequently, a regular follow-up shall be conducted based on comprehensive tumor treatment and individualized treatment plans.
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(See the following page for the list of editorial board members)
List of editorial board members
Author
Gao Song (Beijing Cancer Hospital), Wang Jian (Peking University First Hospital), Yang Wuwei (Fifth Medical Center, General Hospital of the Chinese People's Liberation Army), Yu Haipeng (Tianjin Medical University Cancer Hospital), Xing Wenge (Tianjin Medical University Cancer Hospital).
Responsible editorial board members
Wang Zhongmin (Ruijin Hospital, Shanghai Jiaotong University School of Medicine), Yan Zhiping (Zhongshan Hospital, Fudan University), Cheng Yingsheng (Shanghai Tenth People’s Hospital), Zhu Xu (Beijing Cancer Hospital), Zhang Fujun (Sun Yat-Sen Univerisity Cancer Center), Guo Zhi (Tianjin Medical University Cancer Hospital), Xiao Yueyong (The First Medical Center of the General Hospital of the Chinese People's Liberation Army), Xu Ke (The First Hospital of China Medical University), Zou Yinghua (Peking University First Hospital), Teng Gaojun (Zhongda Hospital Southeast University).
Editorial board members (in alphabetical order of surnames)
Cheng Yingsheng (Shanghai Tenth People’s Hospital), Duan Feng (The First Medical Center of the General Hospital of the Chinese People's Liberation Army), Duan Liuxin (Rocket Force Characteristic Medical Center), Fan Weijun (Sun Yat-sen University Cancer Center), Feng Huasong (The Sixth Medical Center of PLA General Hospital), Feng Weijian (Fuxing Hospital, Capital Medical University), Gao Song (Peking University Cancer Hospital ), Gu Yuming (The Affiliated Hospital of Xuzhou Medical University), Guo Jianhai (Peking University Cancer Hospital), Guo Zhi (Tianjin Medical University Cancer Hospital), Han Jianjun (Shandong Cancer Hospital), Hu Kaiwen (Oriental Hospital of Beijing University of Chinese Medicine), Huang Ming (Yunnan Cancer Hospital), Huang Jinhua (Sun Yat-sen Univerisity Cancer Hospital), 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 (The First Affiliated Hospital,Sun Yat-sen University), Li Quanwang (Oriental Hospital of 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 Univerisity Cancer Hospital), Liu Yu’e (Shanxi Provincial People’s Hospital), Ma Yilong (Guangxi Medical University Cancer Hospital), Mao Aiwu (Tongren Hospital Shanghai Jiaotong University School of Medicine), Meng Zhiqiang (Fudan University Shanghai Cancer Center), Mou Wei (First Affiliated Hospital of Army Medical University), Ni Caifang (The First Affiliated Hospital of Soochow University), Niu Lizhi (Fuda Cancer Hospital), Ren Weixin (The First Affiliated Hospital of Xinjiang Medical University), Shao Guoliang (Zhejiang Cancer Hospital), Shao Haibo (The First Hospital of China Medical University), Si Tongguo (Tianjin Medical University Cancer Hospital), Song Li (Peking University First Hospital), Su Hongying (The First Hospital of China Medical University), Sun Junhui (The First Affiliated Hospital Zhejiang University), Tang Jun (Shandong Institute of Medical Imaging), Teng Gaojun (Zhongda Hospital Southeast University), Wang Jian (Peking University First Hospital), Wang Weidong (The First Medical Center of the General Hospital of the Chinese People's Liberation Army), Wang Zhongmin (Ruijin Hospital, Shanghai Jiaotong University School of Medicine), Wu Gang (The First Affiliated Hospital of Zhengzhou University), Xiao Yueyong (The First Medical Center of the General Hospital of the Chinese People's Liberation Army), Xing Wenge (Tianjin Medical University Cancer Hospital), Xiong Bin (Union Hospitlal Tongji Medical College Huazhong University of Science and Technology), Xu Ke (The First Hospital of China Medical University), Xu Linfeng (Sun Yat-sen Memorial Hospital, 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 Military Medical University), Yang Renjie (Peking University Cancer Hospital), Yang Weizhu (Fujian Medical University Union Hospital), Yang Wuwei (Fifth Medical Center, General Hospital of the Chinese People's Liberation Army), Yang Yefa (Shanghai Oriental Hepatobiliary Hospital), Yang Zhengqiang (Cancer Hospital Chinese Academy of Medical Sciences), Ye Xin (Shandong Provincial Hospital), Yin Guowen (Jiangsu Cancer Hospital), Yu Changlu (Tianjin Third Hospital), Yu Haipeng (Tianjin Medical University Cancer Hospital), Yu Youtao (The Fourth Medical Center of the General Hospital of the Chinese People's Liberation Army), Zhai Bo (Renji Hospital, Shanghai Jiaotong University School of Medicine), Zhang Lin (Beijing Tsinghua Changgeng Hospital), Zhang Jin (Guangzhou Wemen and Children's Medical Center), Zhang Fujun (Sun Yat-sen Univerisity Cancer Center), Zhang Yuewei (Beijing Tsinghua Changgeng 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 (The Affiliated Hospital of Guizhou Medical University), Zhou Chengzhi (The First Clinical College of Guangzhou Medical University), Zhu Xu (Peking University Cancer Hospital), Zou Yinghua (Peking University First Hospital).
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