Electrochemotherapy is becoming a well-established treatment for malignancies of skin and non-skin origin and its use is widening across Europe. The technique was developed and optimized from solid experimental and clinical evidence. A consensus document is now warranted to formalize reporting results, which should strengthen evidence-based practice recommendations. This consensus should be derived from high quality clinical data collection, clinical expertise and summarizing patient feedback. The first step, which is addressed in this paper, aims to critically analyze the quality of published studies and to provide the recommendations for reporting clinical trials on electrochemotherapy. The quality of reporting in published studies on electrochemotherapy was analyzed in order to produce procedure specific reporting recommendations. A comprehensive literature search of studies published from 2006 to 2015 was performed followed by qualitative analysis of manuscripts assessing for 47 quality criteria grouped into four major clusters: (1) trial design, (2) description of patient population, (3) description of treatment delivery and patient outcome, (4) analysis of results and their interpretation. The summary measure during literature assessment was the proportion of studies fulfilling each manuscript quality criteria. A total of 56 studies were screened, from the period 2006 to 2015, of which 33 were included in the qualitative analysis, with a total of 1215 patients. Overall, the quality of reporting was highly variable. Twenty-four reports (73%) were single-center, non-comparative studies, and only 15 (45%) were prospective in nature (only 2 of them were entered into a clinical trials registry). Electrochemotherapy technique was consistently reported, with most studies (31/33) adhering closely to published standard operating procedures. The quality of reporting the patient population was variable among the analyzed studies, with only between 45% and 100% achieving dedicated quality criteria. Reporting of treatment delivery and patient outcome was also highly variable with studies only fulfilling between 3% and 100%. Finally, reporting study results critically varied, fulfilling from 27% to 100% of the quality criteria. Based on the critical issues emerging from this analysis, recommendations and minimal requirements for reporting clinical data on electrochemotherapy were prepared and summarized into a checklist. There is an increasing body of published clinical data on electrochemotherapy, but more high quality clinical data are needed. Published papers often lack accurate description of study population, treatment delivery as well as patient outcome. Our recommendations, provided in the form of a summary checklist, are intended to ameliorate data reporting in future studies on electrochemotherapy and help researchers to provide a solid evidence basis for clinical practice.
COBISS.SI-ID: 11290708
Introduction: Electrochemotherapy was evaluated as a treatment modality for treatment of colorectal liver metastases. Prospective studies were designed to evaluate the feasibility, safety and efficacy. Patients and methods: Patients from the prospective pilot trial and phase II study were followed for the response to the treatment and adverse events. During open surgery electrochemotherapy was performed with electrodes with fixed or variable geometry. Electrodes were inserted into and around the tumor to cover the whole tumor area and the margin of normal tissue with a sufficiently high electric field, according to the individualized treatment plan. Pulses were delivered 8-28 minutes after the intravenous administration of bleomycin (15,000 IU/m2) and were synchronized with the electrocardiogram. The results: Pathologic analysis showed a significantly lower percentage of residual vital tumor tissue in electrochemotherapy treated metastases than in non-electrochemotherapy treated metastases, namely 9.9 ± 12.2% and 34.1 ± 22.5% of viable tissue, respectively. Radiological evaluation showed 85% complete responses and 15% partial responses with no statistically significant difference between metastases treated with fixed or variable geometry electrodes. No serious adverse events were reported due to electrochemotherapy. Conclusion: Electrochemotherapy is feasible, safe and efficient treatment modality for colorectal liver metastases treatment. Further investigations could gain new improvements and knowledge for further application of the method to other internal organs.
COBISS.SI-ID: 2118523
Electrochemotherapy is effective in treatment of various cutaneous tumors and could be translated into treatment of deep-seated tumors. With this aim a prospective pilot study was conducted to evaluate feasibility, safety, and efficacy of intraoperative electrochemotherapy in the treatment of colorectal liver metastases. Electrochemotherapy with bleomycin was performed during open surgery, by insertion of long needle electrodes into and around the tumor according to the individualized pretreatment plan. A 29 metastases in 16 patients were treated in 16 electrochemotherapy sessions. No immediate (intraoperative) and/or postoperative serious adverse events related to electrochemotherapy were observed. Radiological evaluation of all the treated metastases showed 85% complete responses and 15% partial responses. In a group of seven patients that underwent a second operation at 6-12 weeks after the first one, during which electrochemotherapy was performed, the histology of resected metastases treated by electrochemotherapy showed less viable tissue compared to non-treated ones. Electrochemotherapy of colorectal liver metastases proved to be feasible, safe, and efficient treatment modality, providing its specific place in difficult to treat metastases, located in the vicinity of major hepatic vessels, not amenable to surgery or radiofrequency ablation.
COBISS.SI-ID: 1766267
In this study, we investigated the effects of intra-abdominal ECT of colorectal liver metastases on functioning of the heart during the early post-operative care period. No major heart rhythm changes (i.e., induction of extrasystoles, ventricular tachycardia or fibrillation) or pathological morphological changes (i.e., ST segment changes) indicating myocardial ischemia were found. However, we found several minor statistically significant but clinically irrelevant changes in HRV parameters after ECT procedures: a decrease in median values of the mean NN interval, a decrease in the low-frequency and in the normalized low-frequency component, and an increase in the normalized high-frequency component. Only minor statistically significant, but clinically irrelevant effects of intra-abdominal ECT treatment on functioning of the heart were found. The nature of these changes is such that they can be attributed to the known effects of the drugs given to the patients in the post-operative care. Further investigation is still warranted to unambiguously resolve whether ECT with high voltage EP pulses applied in immediate vicinity of the heart is responsible for the observed effects.
COBISS.SI-ID: 11104596
Incidence of primary liver tumors is rising across the world. Patients with primary liver tumors can be treated radically with liver resection of the tumors and liver transplantation. When radical treatment is not indicated due to patient condition or tumor extent, transarterialchemoembolization (TACE), radiofrequency ablation (RFA), and other methods provide hope for longer survival of those patients. Patients, in whom those methods are not recommendable, have a stage C disease suitable only for palliative treatment. Therefore, for the treatment of patients with primary liver tumors with electrochemotherapy, a clinical trial was created at our institution, Clinical Department of Abdominal Surgery at the University Clinical Centre Ljubljana. Phase I study is underway in patients who fulfil inclusion criteria.
COBISS.SI-ID: 2117243