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Additional Papers on Irreversible Electroporation for Treating Pancreatic Cancer

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Additional Papers on Irreversible Electroporation for Treating Pancreatic Cancer IP 1023 [IPG442] NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of irreversible electroporation for treating pancreatic cancer Treating pancreatic cancer using bursts of electricity Irreversible electroporation is a process that uses electrical pulses to kill cancer cells. It is applied directly to a pancreatic cancer tumour through special needles. The main difference between this procedure and thermal techniques for destroying tumours is that it does not produce extreme heat or cold. This means that it may cause less damage to healthy surrounding tissues than some other procedures. Introduction The National Institute for Health and Clinical Excellence (NICE) has prepared this overview to help members of the Interventional Procedures Advisory Committee (IPAC) make recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion. It should not be regarded as a definitive assessment of the procedure. Date prepared This overview was prepared in May 2012 and updated in September 2012. Procedure name Irreversible electroporation for treating pancreatic cancer Specialist societies British Society of Interventional Radiology The Great Britain and Ireland Hepato-Pancreato-Biliary Association The Royal College of Radiologists. IP overview: Irreversible electroporation for treating pancreatic cancer Page 1 of 23 IP 1023 [IPG442] Description Indications and current treatment Pancreatic cancer is relatively uncommon. In 2008, there were 8085 newly diagnosed cases of pancreatic cancer in the UK. The condition tends to affect people aged between 50 and 80 years. Pancreatic cancers are divided into 2 main groups, exocrine and endocrine tumours. Exocrine tumours start in the exocrine cells, which make digestive enzymes. Over 95% of pancreatic cancers are classified as exocrine tumours and about 90% of these are pancreatic ductal adenocarcinomas. Endocrine tumours (also called neuroendocrine tumours) start in the hormone-producing cells and account for less than 5% of all pancreatic cancers. Pancreatic cancer tends to develop silently, causing few symptoms until the disease is well advanced. As potentially curative surgery is seldom an option, most patients can be offered only palliative treatment to relieve their symptoms, and outcomes remain poor. Palliative stenting of the bile duct and duodenum can be used to control complications of pancreatic cancer such as jaundice and gastric outlet obstruction. Other treatment options include palliative chemotherapy and radiotherapy. These can be used to reduce the size of an inoperable tumour so it becomes operable, but this is rare. The aim of irreversible electroporation (IRE) is to destroy cancerous cells by subjecting them to a series of short electrical pulses using high-voltage direct current. This creates multiple holes in the cell membrane, irreversibly damaging the cell’s homeostasis mechanisms and leading to cell death. IRE is a non-thermal cell-destruction technique which is claimed to allow targeted destruction of cancerous cells with less damage to surrounding supporting connective tissue (such as nearby blood vessels and nerves) than other types of treatment.). What the procedure involves The procedure is performed with the patient under general anaesthesia. A neuromuscular blocking agent is essential to prevent uncontrolled severe muscle contractions caused by the electric current. Bipolar or unipolar electrode needles are introduced percutaneously (or by open surgical or laparoscopic approaches) and guided into place in and adjacent to the tumour using imaging guidance (either computed tomography [CT] or, less commonly, ultrasound). The distance between the electrodes is confirmed by imaging to ensure that the electrodes are correctly placed parallel to one another and that sufficient current flow would be generated to ensure IRE. Each ablation cycle consists of pulses of high-voltage direct current delivered in groups (of about 10) with a brief time for recharging between groups (a cycle is usually completed in less than 2 minutes). Electrodes may be repositioned under imaging guidance to extend the zone of electroporation IP overview: Irreversible electroporation for treating pancreatic cancer Page 2 of 23 IP 1023 [IPG442] until the entire tumour and an appropriate margin have been ablated. The number of ablations is determined by the volume of the target tumour. When the ablation procedure is completed, further imaging may be carried out to confirm satisfactory ablation. Total procedure time has been reported to range from 2.5 to 4.5 hours. Cardiac synchronisation is used to time delivery of the electrical pulse within the refractory period of the heart cycle, minimising the risk of arrhythmias. Precautions should be taken for patients with implantable electrical devices. Ablation of lesions in the vicinity of implanted electronic devices or implanted devices with metal parts should be avoided. It is important to ensure that interventions (such as a defibrillator) and people trained to treat cardiac arrhythmias are available. Literature review Rapid review of literature The medical literature was searched to identify studies and reviews relevant to irreversible electroporation for treating pancreatic cancer. Searches were conducted of the following databases, covering the period from their commencement to 27 September 2012: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches (see appendix C for details of search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion. The following selection criteria (table 1) were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved. IP overview: Irreversible electroporation for treating pancreatic cancer Page 3 of 23 IP 1023 [IPG442] Table 1 Inclusion criteria for identification of relevant studies Characteristic Criteria Publication type Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature. Patient Patients with pancreatic cancer. Intervention/test Irreversible electroporation. Outcome Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy. Language Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base. List of studies included in the overview This overview is based on 241 patients from 1 case series1, 1 case report2 and 6 conference abstracts3-8. Other studies that were considered to be relevant to the procedure but were not included in the main extraction table (table 2) have been listed in appendix A. IP overview: Irreversible electroporation for treating pancreatic cancer Page 4 of 23 IP 1023 [IPG442] Table 2 Summary of key efficacy and safety findings on irreversible electroporation for treating pancreatic cancer Abbreviations used: AJCC, American Joint Committee on Cancer; CI, confidence interval; CT, computed tomography; ICU, intensive care unit ; IRE, irreversible electroporation; mcg, microgram; MRI, magnetic resonance imaging; PET, positron emission tomography; RFA, radiofrequency ablation; US, ultrasound Study details Key efficacy findings Key safety findings Comments IP overview: Irreversible electroporation for treating pancreatic cancer Page 5 of 23 IP 1023 [IPG442] Abbreviations used: AJCC, American Joint Committee on Cancer; CI, confidence interval; CT, computed tomography; ICU, intensive care unit ; IRE, irreversible electroporation; mcg, microgram; MRI, magnetic resonance imaging; PET, positron emission tomography; RFA, radiofrequency ablation; US, ultrasound Study details Key efficacy findings Key safety findings Comments Martin R (2012)1 Number of patients analysed: 27 Death (<90 days) Follow-up issues: Case series Technical success 1 death occurred 70 days after IRE (related to a Imaging was performed at USA All patients underwent successful IRE. partial portal vein thrombus because of oedema time of discharge or within after ablation). Before IRE, the patient was noted two weeks of IRE Recruitment period: 2009–2011 At 90-day follow-up for all patients, there was 100% to have partial portal vein thrombosis, which had treatment, then at 3 month ablation success with no evidence of local Study population: Patients with been stable for 4 months without anticoagulation. intervals. occurrence. Ablation success was defined as ability advanced, unresectable pancreatic At 45 days after IRE the patient presented with Study design issues: adenocarcinoma. Fifteen had to deliver planned therapy in the operative room and worsening ascites, hepatic and renal failure and Primary objective; to pancreatic head lesions, 12 had lesions no evidence of residual tumour recurrence. A treaded with anticoagulation. evaluate safety and efficacy in the body/neck of the
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