In order to standardize the clinical application of tumor radiofrequency ablation therapy technology, improve the service level, ensure medical quality and medical safety, and reduce various complications, this specification is formulated. This specification is the basic requirement for medical institutions and their physicians to carry out tumor radiofrequency ablation treatment technology. The tumor radiofrequency ablation treatment technology referred to in this specification refers to the local treatment technology that directly destroys tumor by physical methods, excluding other ablation treatment technologies such as microwave, laser, ultrasound, high frequency electrocautery, freezing, etc. A, the basic requirements of medical institutions (a) medical institutions to carry out tumor radiofrequency ablation therapy technology, should be compatible with its function and task. 1, the technology is limited to the second level A and above hospitals, and has the health administrative department approved the registration of relevant diagnosis and treatment subjects. 2, the applicant must have the ability to independently carry out gastrointestinal surgery, hepatobiliary surgery, general thoracic surgery, CT or B ultrasound and other medical imaging-guided liver puncture biopsy, lung puncture biopsy and other techniques. (B) basic equipment requirements 1. Medical institutions are required to have tumor radiofrequency ablation equipment system approved by the State Food and Drug Administration for clinical treatment, currently the medical market mainly includes Cool-tip RF System (cold circulation super power RF tumor treatment system), Rita System (Rita RF liver cancer treatment system), Radio Therapeutics System (multi-bullet RF tumor treatment system), etc. The components of RF ablation therapy instrument include RF generator, treatment electrode and neutral electrode plate, and the main electrodes are: ① hollow cooling electrode; ② unfolded multi-hook electrode; ③ perfusion electrode; ④ pulse electrode, etc. 2.With special room for storing tumor radiofrequency ablation equipment and radiofrequency treatment needles and accessories storage cabinet, and a person responsible for registration and storage. 3.With image-guided technical equipment, such as ultrasound, CT or MRI, etc. and medical image management system. And with contrast-enhanced imaging technology conditions for assessing local efficacy. 4.Equipped with multi-functional monitor, which can monitor ECG, respiration, blood pressure, pulse rate and oxygen saturation during the ablation process; capable of performing cardiac, pulmonary and cerebral resuscitation, with oxygen channels, anesthesia machines, defibrillators, suction devices and other necessary emergency equipment and drugs. 5.To carry out open surgery tumor radiofrequency ablation treatment technology, still need to have the technical equipment for image guidance in surgery. 6.To carry out laparoscopic tumor radiofrequency ablation treatment technology, it is necessary to have laparoscopic examination and treatment equipment, medical image graphic management system; special storage cabinet for laparoscope and accessories, and a person responsible for registration and storage. 7, with the operating room conditions required to carry out tumor surgery, such as anesthesia monitoring system, other corresponding instruments and equipment, etc. 8, with the corresponding operating room and other facilities to carry out the technology, sterilization and aseptic conditions should meet the corresponding management standards. Basic requirements of personnel There are at least 2 physicians with clinical application ability of tumor radiofrequency ablation therapy technology, and other professional and technical personnel who have been trained in tumor radiofrequency ablation therapy related knowledge and technology. (1) Tumor radiofrequency ablation physician 1. A registered physician of the hospital who has obtained “Physician’s Practice Certificate” and the scope of practice is to carry out the profession related to the application of this technology. 2.Passed the system training and examination of the tumor radiofrequency ablation technology training base recognized by the Department of Health of Zhejiang Province. 3.Applicants for independent operation of B-ultrasound-guided tumor radiofrequency ablation technology must have the qualification of attending physician or above and more than 3 years of clinical work experience in tumor diagnosis and treatment, and must have undergone B-ultrasound-guided tumor radiofrequency ablation technology training and completed 15 cases of B-ultrasound-guided tumor radiofrequency ablation technology operation under the guidance of superior physicians without serious post-operative complications, and after passing the assessment. Only after passing the evaluation can they independently carry out B-ultrasound-guided tumor radiofrequency ablation technology. 4.Applicants for independent CT-guided tumor radiofrequency ablation technology must be qualified for professional and technical positions of associate chief physician or above, have more than 5 years of clinical work experience in tumor diagnosis and treatment, must be trained in CT-guided tumor radiofrequency ablation technology, and have the basic concept of tumor-free operation and aseptic operation and its basic technology. He must also complete 15 cases of CT-guided tumor radiofrequency ablation technology operations under the guidance of superior physicians and without serious postoperative complications, and only after passing the assessment can he independently carry out CT super-guided tumor radiofrequency ablation technology. (2) Other health professionals and technicians (including image guidance, anesthesia, nurses) involved in tumor RF ablation therapy need to be trained in the system of knowledge and technology related to tumor RF ablation therapy. (3) Basic requirements of technical management (a) Strictly abide by the technical operation specification of tumor radiofrequency ablation therapy and the diagnosis and treatment guidelines, correctly master the indications and contraindications of tumor radiofrequency ablation therapy, and decide the comprehensive treatment plan according to the patient’s condition, the available treatment means and the patient’s financial ability. (2) To be carried out by our physicians with corresponding clinical application ability of tumor radiofrequency ablation treatment technology, and to formulate reasonable treatment and management plan. (c) Before the implementation of tumor radiofrequency ablation treatment, patients and families should be informed of the purpose of treatment, treatment risks, post-treatment precautions, possible complications and preventive measures, etc., and sign the informed consent form. (d) The process of percutaneous ablation must be performed under imaging guidance and monitoring to improve the safety and reliability of the treatment. (e) The condition should be closely observed after tumor radiofrequency ablation treatment, and possible complications should be dealt with in a timely manner. (6) Establish and improve the technical evaluation and follow-up system of tumor radiofrequency ablation treatment, and make records according to regulations. (g) Medical institutions and physicians shall, in accordance with relevant regulations, regularly undergo clinical application assessment of tumor radiofrequency ablation therapy technology, including case selection, treatment success rate, serious complications, death cases, occurrence of medical accidents, post-treatment patient management, patient survival quality, follow-up and quality of medical records, etc. (H) The medical institution completes no less than 50 cases of tumor radiofrequency ablation treatment each year; no medical incidents related to tumor radiofrequency ablation treatment. (ix) Other technical management requirements 1. Use the tumor radiofrequency ablation treatment equipment approved by the national drug supervision and management department. 2, shall not violate the repeated use of disposable tumor radiofrequency ablation treatment equipment, shall not seek improper benefits through the equipment. 3.Establish regular instrument and equipment testing, maintenance system and use registration system. IV. Training The physician to be engaged in tumor radiofrequency ablation therapy should receive at least 6 months of systematic training. (A) training base Designated by the administrative department of Zhejiang Provincial Health Department, and has the following conditions: 1. Grade 3 A hospital. With medical oncology, surgical oncology, radiotherapy oncology, ultrasound, radiology, general surgery, cardiothoracic surgery and other related departments. 2.With the ability of clinical application of tumor radiofrequency ablation treatment technology, the annual completion of various types of tumor radiofrequency ablation treatment cases is not less than 60 cases. 3.The total number of beds for medical oncology and surgical oncology (or general surgery) and interventional treatment is not less than 150. 4.There are at least 4 instructing physicians with the ability of clinical application of tumor radiofrequency ablation treatment technology (including image guidance), of which at least 1 is the chief physician. 5.There are personnel, technology, equipment and facilities that are compatible with the training work of tumor radiofrequency ablation therapy. 6. The clinical application of tumor radiofrequency ablation therapy has been carried out for more than 5 years. (2) Basic requirements of the training base 1.Training materials and training syllabus are approved by Zhejiang Provincial Health Department. 2.To ensure that the trained physicians complete the required training within the specified time. 3, after the end of training, the physician undergoing training examinations, assessments, and issued a conclusion on whether to pass. 4.For each physician receiving training to establish training and examination, examination files. 5.Decide the number of physicians to be trained according to the actual situation and training capacity. (3) Training requirements for physicians in clinical application of tumor radiofrequency ablation therapy 1.Under the guidance of superior physicians, participate in completing no less than 15 cases of tumor radiofrequency ablation therapy and pass the examination. 2.Under the guidance of superior physician, participate in the whole process management of tumor radiofrequency ablation treatment patients, including preoperative evaluation, interpretation of diagnostic test results, joint consultation with other disciplines, tumor radiofrequency ablation treatment operation, tumor radiofrequency ablation treatment process record, perioperative treatment, intensive care treatment and postoperative follow-up. 3. Physicians who have received tumor radiofrequency ablation treatment system training outside the province for more than 6 months and have completed the required number of cases, have the training certificate from the training institution, and have passed the examination and assessment of the training base, can be recognized as having met the required training requirements. V. Other management requirements (a) the implementation of this specification before the following conditions of physicians, can carry out tumor radiofrequency ablation therapy without training and tumor radiofrequency ablation therapy technology clinical application ability evaluation: 1, high professional ethics, peer expert evaluation of high professional and technical level, and get more than 2 chief physicians of this specialty recommended, at least 1 of them is a physician outside the hospital. 2.Continuously engaged in clinical work of tumor radiofrequency ablation treatment in tertiary hospitals for more than 5 years, with professional and technical position qualification of associate chief physician or above. 3.In the past 5 years, the total number of tumor radiofrequency ablation treatment is more than 100 cases, and there is no medical accident related to tumor radiofrequency ablation treatment above the second level, the complication rate is less than 0.5%, and the mortality rate related to tumor radiofrequency ablation treatment is less than 0.1%. (2) Strictly implement the national price and financial policies and charge according to the regulations. The basic principle of tumor radiofrequency ablation therapy is that tumor cells have poorer tolerance to heat than normal cells. The high frequency radiofrequency wave generated by radiofrequency generator sends out radiofrequency current through the electrode inserted into tumor tissue, and then forms a circuit through the auxiliary electrode, which generates heat through the molecular friction and ion escape in the surrounding tissues. The mechanism of radiofrequency ablation for tumor treatment includes: ① high temperature causes coagulative necrosis of tumor tissues in the target area and directly kills tumor cells; ② high temperature affects the phase change and fluidity of tumor cell plasma membrane, thus affecting various functions of cell membrane; ③ high temperature increases the activity of lysosomal enzymes in tumor cells and affects the normal function of various cell organelles, especially mitochondria; ④ high temperature causes coagulation of vascular tissues around the tumor and forms a reaction zone. (5) In the process of coagulation necrosis of tumor cells, the exposure of antigen in cell membrane and other parts or the change of immune phenotype of tumor cells can stimulate the body to produce specific antibodies to kill or inhibit the growth or spread of tumor, which is called “endogenous tumor vaccine”; (6) It leads to apoptosis of tumor cells. It can stimulate the body to produce specific antibodies to kill or inhibit the growth or spread of tumor, which is called “endogenous tumor vaccine”. Patients who receive radiofrequency ablation therapy must meet the following conditions: 1. Malignant tumor with clear pathological histology and cytology. 2. 2.Sign the informed consent of tumor radiofrequency ablation treatment. 3.Child-Pugh A or B liver function, or Child C grade with preparation to reach B grade. 4.No serious liver, kidney, heart, lung, brain and other organ dysfunction, normal or near normal coagulation function. Prothrombin time does not exceed 50% of normal control, platelet >50×109/L. 5.Single tumor ≤5 cm in diameter or multiple nodules within 3 nodes with maximum diameter ≤3 cm, without vascular or bile duct invasion or distant metastasis; small hepatocellular carcinoma that is unwilling to receive surgical treatment or has contraindications to surgery; deep central small hepatocellular carcinoma, recurrence after surgical resection or residual small nodules. 6.Palliative treatment for middle and late stage hepatocellular carcinoma that cannot be surgically resected for various reasons 7.Patients waiting for tumor growth control before liver transplantation as well as recurrence and metastasis after transplantation. 8.Supplementary treatment for large hepatocellular carcinoma after embolization chemotherapy via hepatic artery cannula. 9.Adjuvant therapy before and after chemotherapy for metastatic tumors of the liver. 10.Palliative treatment of lung malignant tumor. 11.There have been studies reporting the use of radiofrequency ablation therapy technology for malignant tumors such as renal tumors, breast tumors and skeletal tumors, but there is a lack of sufficient evidence-based medicine to support it. In addition, due to the limitations of local treatment, radiofrequency ablation is not recommended for lesions >5 cm according to the current technology. For multiple lesions or larger tumors, pre-treatment hepatic artery chemoembolization (TACE or TAE) combined with radiofrequency ablation is significantly better than radiofrequency ablation alone depending on the patient’s liver function; for tumors located on the surface of the liver, adjacent to the heart and diaphragm and gastrointestinal canal, open or laparoscopic treatment can be chosen, or radiofrequency ablation combined with anhydrous alcohol injection can be used. In addition, TACE or other treatments after RF ablation may also improve the efficacy. The main contraindications include the following: 1. Tumors located on the liver surface, more than 1/3 of which are exposed. 2. 2.Child-Pugh grade C liver function and tumor with distant organ metastasis. 3.Diffuse hepatocellular carcinoma, or combined with portal trunk to secondary branches or hepatic vein carcinoma thrombosis. 4.Severe jaundice, especially obstructive jaundice, or significant atrophy of the liver, tumor is too large and the scope of radiofrequency ablation needs to reach one-third of the liver volume. 5.Ruptured esophageal (fundus) varices bleeding in the recent 1 month. 6.Severe liver, kidney, heart, lung, brain and other major organ failure. 7.Active infection especially inflammation of the biliary system, etc. 8, uncorrectable coagulation dysfunction and serious blood abnormalities, with serious bleeding tendency. 9, intractable massive ascites, malignant fluid. 10.Patients with pregnancy, impaired consciousness or unable to cooperate with treatment. Radiofrequency ablation has various ways of implementation, mainly including percutaneous, trans-laparoscopic and open abdominal, and the specific way depends on the location, size and growth mode of tumor. The advantages and disadvantages of each route are as follows: (1) percutaneous route: it is most suitable for 1 to 3 lesions with diameter ≤3 cm located around the liver, and has the advantages of short hospital stay and low complication rate; the most common imaging localization method for percutaneous RF ablation is ultrasound, and CT is mostly used for patients whose lesions are close to the top of the diaphragm or cannot be investigated by ultrasound. (2) Laparoscopic route: Mostly used when the lesion is located on the surface of the liver or cannot be detected by ultrasound. This route can accurately detect and treat liver lesions, and can detect extrahepatic metastases in the abdominal cavity, and can also safely treat intrahepatic lesions in the adjacent surrounding organs, and the ablation effect can be increased by temporarily blocking the blood flow of intrahepatic vessels and reducing the thermal attenuation effect caused by blood flow under hand-assisted laparoscopy. Radiofrequency ablation under open abdomen: radiofrequency under open abdomen is suitable for patients with larger tumors (>5cm), more lesions, lesions adjacent to peripheral organs such as stomach, intestines and kidneys, and patients who have a history of abdominal surgery and cannot be performed under laparoscopy. Operation procedure Pre-operative examination and preparation: detailed medical history, careful reading of pre-operative CT and MRI films, strict compliance with the operation specification and treatment guideline of tumor ablation therapy, correct mastering of the indications and contraindications of tumor ablation therapy, comprehensive judgment according to the patient’s condition, selectable treatment means and the patient’s economic ability, etc., to decide the treatment plan. Before the implementation of tumor radiofrequency ablation treatment, patients and their families should be informed of the treatment purpose, treatment risks, post-treatment precautions, possible complications and preventive measures, and sign the informed consent form. (1) Preoperative evaluation and laboratory examination of patients: ECOG score of 3 or less for tumor patients. Review blood routine, blood type, liver and kidney function, and complete set of bleeding and clotting time. (2) Other preoperative examinations: mainly include monitoring vital signs such as blood pressure and pulse rate, receiving routine chest X-ray (to observe the presence of emphysema and pleural hypertrophy) and electrocardiogram, abdominal ultrasound and other examinations. If clinical consideration is needed to pass through the lung for radiofrequency ablation treatment of liver area near the top of the diaphragm or lung tumor, lung function should also be tested. (3) Preoperative preparation: fasting and water fasting for 6 hours before surgery. Empty the bladder before surgery. Prepare intravenous indwelling needle and open intravenous access. For highly tense patients, instruct them to relax and take diazepam 10mg orally 1 hour before surgery. explain the purpose of RF ablation treatment to the patient and try to choose supine position and avoid oblique position. Breathing should be done in a calm inspiratory position and closed at the end. If there is significant coughing affecting the operation, take codeine 30mg 1 hour before the procedure. if anticoagulant drugs (e.g. aspirin, etc.) are used, they should be stopped at least 72h before the RF ablation treatment. Intramuscular pethidine injection 75-100mg analgesia 30 minutes to 1 hour before surgery. (4) Item preparation: RF therapy instrument (including cooling circulator), RF therapy needle, phlebotomy kit, ice, imipramine 5mg; 5ml syringe or 10ml syringe, 18G intravenous indwelling needle, 2% lidocaine, iodine and swabs, tape, lap band, sphygmomanometer and stethoscope, sterile gloves. Prepare plasma or platelets if necessary. The operating room should have oxygen, sputum, cardiac monitoring and defibrillator, and resuscitation drugs on hand. 2.Operating method Emphasize that the operation should be guided by imaging technology to ensure the safety, accuracy and effectiveness of treatment. The scope of ablation should aim to include the paracancerous tissues above 0.5 cm in order to obtain a “safe margin” and kill the tumor completely. For infiltrating or metastatic carcinoma with unclear boundary and irregular shape, it is recommended to extend the safe peri-tumor area to 1 cm or more if the adjacent liver tissues and structural conditions permit. The operation steps are as follows: (1) Choose supine position as far as possible. Connect the RF cable and electrode plate between the electrode and the host, and the electrode patch needs to be routinely preapplied to the hairless part of bilateral thighs before the operation. (2)The skin should be routinely disinfected, sterile cavity towel should be laid, and local anesthesia of 2% lidocaine should reach the liver peritoneum. When it is estimated in advance that RF ablation may cause moderate to severe pain, it is strongly recommended to perform under intravenous anesthesia to ensure that RF ablation is performed smoothly. (3) It must be performed under imaging guidance and monitoring, and multiple foci can be treated repeatedly; the patient should be closely observed during treatment to detect possible complications in a timely manner. (4)During the process of radiofrequency ablation, the vital signs should be monitored; generally a treatment process takes about 8-12 minutes, larger lesions need to be maintained for 24 minutes or even longer; the machine will automatically stop the ablation at the scheduled time; after the ablation is completed, needle tract ablation is performed when the needle is removed to prevent postoperative bleeding and tumor implantation along the needle tract; according to the situation, decide whether to ablate other locations. (5) The occurrence of complications such as internal bleeding, pneumothorax and gastrointestinal perforation should be closely observed during the process of tumor ablation treatment. V. Evaluation and follow-up of the efficacy of radiofrequency ablation Establish and improve the technical evaluation and follow-up system of tumor radiofrequency ablation treatment and record it according to the regulations. After ablation treatment, the necrosis of lesion should be observed regularly, and if there is residual lesion, remedial treatment should be actively carried out to improve the efficacy of radiofrequency ablation treatment. The standard method to evaluate the local efficacy is to determine whether the tumor is completely ablated (Complete ablation) by contrast-enhanced CT/MRI or ultrasonography about one month after radiofrequency ablation. For patients with more iodine deposits in the lesion, MRI enhancement can be used, which can avoid iodine artifacts and is more accurate than CT. A lesion with complete ablation shows no blood supply at all, i.e., no enhancement. If ablation is incomplete, remedial treatment can be given. If complete ablation cannot be obtained after 3 ablations, ablation therapy should be abandoned and other treatments should be used instead. Precautions 1. Preoperative liver function loss and significantly prolonged clotting time should be prepared with plasma, and platelet or clotting factor transfusion is needed if necessary. For cirrhotic patients with coagulation disorders, a small dose of recombinant factor VIIa should be given; for patients with platelet count <50,000/mm3, PT prolongation >4 seconds, liver function loss can be corrected by transfusion of plasma and platelets. 2.Patients must be trained to hold their breath several times in advance before surgery to cooperate with the operation. The radiofrequency treatment needle should never be stirred after entering the liver. 3.Vital signs should be routinely monitored within 12 hours after surgery, first every 30 minutes to 1 hour, and then every 2 hours if stable. If blood pressure decreases during this period and there are signs of bleeding, consider using hemostatic drugs, blood transfusion (such as concentrated red blood cells, plasma or platelets), and if necessary, request surgical consultation for surgical exploration. 4.Patients with heart valve disease or those at risk of bacteremia need to be given antibiotics prophylactically; if intraoperative treatment of liver tumor or lung tumor at the top of the diaphragm via lung, preoperative prophylactic antibiotics and postoperative antibiotic treatment can be used. 5. Patients should not move their bodies during radiofrequency treatment, which is very important to complete the surgery and reduce complications. 6.Patients with cardiac pacemakers should be under close cardiac monitoring. 7.Patients are advised to avoid heavy physical labor and strenuous physical activities etc. for one week after the operation. 8. Informed consent must be signed. Radiofrequency ablation treatment has the following risks: anesthesia accident such as cardiac arrest, allergic reaction, etc.; bleeding at the site of radiofrequency treatment, liver rupture, pneumothorax, shock, infected or bloody pleural effusion; injury to nerves, kidney, adrenal gland, pancreas, etc.; injury to stomach, colon causing perforation; biliary fistula, biliary peritonitis, liver abscess; electrode skin burns; failure of radiofrequency ablation treatment, needle tract implantation metastasis, postoperative recurrence possible ; portal vein embolism after RF is a major cause of death, especially seen in patients with cirrhosis. And other unpredictable accidents. 9, the prevention and treatment of several common complications: (1) vagal reflex: radiofrequency heat generation on the liver peritoneum and the vagus reflex generated by the stimulation of the vagus nerve in the liver, can cause slowing of the heart rate, arrhythmia, blood pressure drop, serious cases can lead to death. Atropine or sanguinarine can be given for prevention before surgery. If vagal reflex occurs during surgery, atropine or scopolamine can be given. (2) Injury to intra- and extra-hepatic bile ducts: Radiofrequency thermocoagulation of hepatocellular carcinoma in the first hilar region should avoid injuring the larger bile ducts, so the scope of thermocoagulation should not be too large. (3) Injury to perihepatic cavity organs: Especially when there is a history of surgery or imaging examination reveals that the tumor invades the surrounding cavity organs, radiofrequency thermocoagulation should be especially cautious to prevent serious complications such as internal or external fistula caused by injury to the cavity organs for complete thermal coagulation of the tumor. (4) Internal bleeding: For liver tumors that are close to the surface of the liver or protrude outside the liver, puncture should not be performed from the surface of the tumor, but through the tumor-free liver tissue and then into the tumor tissue. Intraoperative and postoperative hemostatic drugs need to be given, and lap band thoracoabdominal compression bandage should be given after treatment. (5) Pneumothorax: avoid penetrating into the thoracic cavity as much as possible under the guidance of B-ultrasound during the operation, pay attention to observe whether the respiration is stable after the operation, if there is respiratory distress, emergency chest X-ray should be given to clarify the diagnosis.