Published ECT Protocol Frameworks
Clinical practice in electrochemotherapy was standardised in 2006 by the ESOPE (European Standard Operating Procedures of Electrochemotherapy) project. The update published in 2018 covers cutaneous tumours and skin metastases. Electrochemotherapy of deep-seated tumours is a separate and later line of development, described here through its own literature. Every figure below carries its source alongside it.
Clinical Reference. This section is independent of the portal's publication counting: the values here are not computed from the corpus but taken from the named procedure, guidance and manufacturer documents, each shown with its source. When the source document is revised, this page changes with it. If you spot an error on this page, write to info@dgmed.com.tr. The portal publishes no clinical review record (reviewer and date) for this page; the content is transcribed from the source documents named above, and what binds are the current versions of those documents.
The Frameworks This Page Rests On
| Document | Its scope | What it sources on this page |
|---|---|---|
| ESOPE standard operating procedures (2006) | Cutaneous and subcutaneous tumour nodules | Drug doses, route, pulse timing, electrode types, follow-up schedule |
| ESOPE study report (2006) | Multicentre practice study | Pulse count, amplitude-to-distance ratio, pulse duration and frequency by electrode type |
| Updated SOP (2018) | Cutaneous tumours and skin metastases; internal-organ tumours are explicitly left outside the scope of this revision | Upper limit for intravenous bleomycin, widened time window, contraindications, retreatment interval |
| Deep-seated literature (2010 onwards) , , , | Liver, bone and other internal sites | Treatment planning, long needle electrodes, ECG synchronisation; a separate framework |
Click the source name at the end of a row to open its citation and abstract. None of these frameworks covers irreversible electroporation.
Drug, Dose and Timing in Cutaneous Electrochemotherapy
Timing is critical: pulses are delivered in the window when the drug has distributed into the tumour tissue
| Agent and route | Published dose | Pulse timing | Source |
|---|---|---|---|
| Bleomycin, intravenous | 15,000 IU/m² body surface area. The 2006 procedure describes a bolus over 30–60 seconds; the 2018 update describes a short infusion over 2–5 minutes and caps the total dose at 30,000 IU (2.0 m²). | Begins 8 minutes after administration is completed. The 2006 procedure recommends finishing at 28 minutes; the 2018 update widens the window to 40 minutes. | , |
| Bleomycin, intratumoural | Solution at 1,000 IU/mL. By tumour volume: 1,000 IU/cm³ for < 0.5 cm³; 500 IU/cm³ for 0.5–1 cm³; 250 IU/cm³ for > 1 cm³. | Within 10 minutes of drug injection | , |
| Cisplatin, intratumoural | The 2006 procedure describes a 2 mg/mL solution; by tumour volume: 2 mg/cm³ for < 0.5 cm³; 1 mg/cm³ for 0.5–1 cm³; 0.5 mg/cm³ for > 1 cm³. The 2018 update recommends a 1 mg/mL mixture for cutaneous tumours and describes the injection dose as filling the tumour volume with drug. Cisplatin is given intratumourally only. | Within 10 minutes of drug injection | , |
| Source | Lifetime cumulative bleomycin limit |
|---|---|
| ESOPE standard operating procedures, 2006 | 400.000 IU/m² |
| Updated SOP, 2018 | 400,000 IU |
The two sources state the limit in different units and the portal does not substitute one for the other. Which threshold applies depends on the procedure document in use and on the treating clinician's assessment.
Eligibility and monitoring thresholds. The 2006 procedure asks that pulmonary function tests be considered once the cumulative dose passes 60,000 IU/m². Creatinine < 150 µmol/L is required for intravenous bleomycin. A lung diffusion capacity test is recommended before treatment in symptomatic pulmonary disease and should be performed before and after treatment in benign indications (vascular malformations and keloids, for example); discontinuation is advised if the value falls by more than 25% from baseline. The volume thresholds here assume tumour volume computed as V = a·b²·π/6.
Pulse Parameters for Electrochemotherapy Only
| Electrode type | Pulse count | Amplitude-to-distance ratio | Pulse duration | Frequency | Source |
|---|---|---|---|---|---|
| Type I, plate | 8 | 1,300 V/cm | 100 µs | 1 Hz or 5,000 Hz | |
| Type II, linear needle | 8 | 1,000 V/cm | 100 µs | 1 Hz or 5,000 Hz | |
| Type III, hexagonal needle | 96 (8 per needle pair) | 1,000 V/cm | 100 µs | 5,000 Hz |
The V/cm values are the ratio of applied voltage to inter-electrode distance, not a field strength measured inside tissue. This table belongs to electrochemotherapy only. Pulse parameters for irreversible electroporation differ, have no single published standard, and are covered on a separate page: Irreversible Electroporation (IRE): Comparative Context.
Electrode Types
| Electrode | Geometry | Published context of use | Source |
|---|---|---|---|
| Type I: plate | Two parallel plates | Superficial and exophytic lesions; a single application may not suffice for nodules thicker than 1 cm | , |
| Type II: linear needle | Two parallel rows of needles | Small nodules; the shorter electrode distance means a lower applied voltage, and the 2018 update recommends this electrode for the facial area | |
| Type III: hexagonal needle | Needle bundle in hexagonal array | Large nodules and wide areas; the 5,000 Hz frequency is mandatory for this electrode | , |
| Variable-geometry long needle | Long needles placed individually according to a treatment plan | Deep-seated tumours. This electrode is not part of the cutaneous SOP; it belongs to the separate framework described below. | , |
The Workflow Defined in the ESOPE Procedures
For cutaneous tumours and skin metastases; each step carries its source at the end
Patient and lesion assessment
Lesion number, size and depth are measured. Where intravenous bleomycin is planned, the lifetime cumulative dose, renal function and lung diffusion capacity are reviewed beforehand; the numeric thresholds are given under the dose table above. ,
Anaesthesia plan
Local anaesthesia is infiltrated along four lines with a 0.5–1 cm margin around the area to be treated, and the lidocaine ceiling is calculated. General anaesthesia is preferred for numerous, extensive or deep lesions.
Drug administration
The chosen agent and route are administered, opening the time window defined in the table above. ,
Electrode placement and pulse delivery
The entire treatment area is covered with a margin; overlapping applications are recommended within tumour tissue while excessive overlap in normal tissue is avoided. The published update gives no numeric value for the coverage margin.
Follow-up and retreatment
The 2006 procedure schedules review at week 4; the 2018 update reports that maximum therapeutic effect is seen at six to eight weeks and states explicitly that there is no data on the minimal interval between retreatments. At least four weeks are recommended where intravenous bleomycin is used. ,
ECT in Deep-Seated Tumours: A Separate and Later Framework
The title of the 2018 update states its scope: cutaneous tumours and skin metastases. The update states explicitly that electrochemotherapy of internal-organ tumours such as liver, pancreas and lung is under clinical investigation and falls outside the scope of that revision. The figures above therefore do not constitute guidance for deep-seated tumours; their validity there has to be shown by separate studies.
Electrochemotherapy of deep-seated tumours developed through its own literature. The first case was a thigh melanoma metastasis treated on the basis of numerical treatment planning, with electrode positions and pulse parameters computed in advance on a model derived from patient imaging.
In the liver, the technical description rests on placing long needle electrodes into the tumour and the surrounding normal tissue according to a treatment plan, and on synchronising the pulses to the electrocardiogram so that they fall outside the vulnerable period of the ventricles. In colorectal liver metastases this approach was later applied in a prospective phase II study covering 84 metastases in 39 patients. ,
For bone metastases, operating procedures were defined in a separate multicentre prospective study of 102 patients across 11 centres. Access routes have widened as well: percutaneous, laparoscopic and endoscopic approaches are treated as their own subject for deep-seated tumours. These studies fall outside the scope of the cutaneous SOP; while they carry over some of its parameters, such as the pulse protocol and the bleomycin limit, they use their own procedure descriptions for electrode placement, treatment planning and access routes. ,
Calcium Electroporation: A Drug-Free Approach
An approach under investigation replaces the cytotoxic drug with high-concentration calcium chloride. Calcium entering the cell after electroporation causes cell death through ATP depletion and loss of homeostasis.
Randomised, double-blind studies comparing it with bleomycin-based electrochemotherapy in cutaneous metastases are present in the corpus. , Calcium electroporation is not part of the ESOPE framework summarised above, however, and no published standard operating procedure for its dose, timing and electrode choice can be reported on this page.