Cholangiocarcinoma, Interventional Imaging
Conditions
Keywords
Cholangiocarcinoma, Irreversible electroporation, Interventional radiology
Brief summary
The aim of the study is to evaluate the feasibility of irreversible electroporation in the treatment of locally advanced cholangiocarcinoma. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.
Interventions
PROCEDUREIrreversible electroporation
Device: NanoKnife The aim of the treatment is to surround the tumour with two to six needles and to deliver a very high voltage current (3000 volts in 70 to 80 microseconds pulses) by a generator synchronized with an electrocardiogram.
Sponsors
Sport & Collection 2019
Poitiers University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 years old * Patient with infiltrating cholangiocarcinoma of the gallstone convergence considered as unresectable on the pre-operative imaging data performed during the month preceding inclusion, and in multidisciplinary consultation meeting specialised in digestive oncology * Histologically (or cytologically) proven tumor of less than 4 cm of the largest diameter * World Health Organization Performance Index 0 or 1 * No history of other cancer, except baso-cellular skin carcinoma or epidermoid cervix cancer or any other cancer in complete remission for more than 3 years * No prior radiotherapy for cholangiocarcinoma * Biological analyses performed during the month preceding inclusion : hepatic enzymes (AST and ALT \<3N), preserved renal function (creatinine clearance according to Modification of the Diet in Renal Disease \>50ml/min); bilirubin \<3N; bile drainage must be correct with a bilirubin below 3N , with or without drainage/prothesis, hemoglobin \>9g/dL, leucocytes \>3500/mm3, platelets \>75000/mm3, prothrombin rate \>70% * Signature of the informed consent
Exclusion criteria
* Cholangiocarcinoma of more than 4cm diameter or resectable according tio the imaging data * Severe and/or uncontrolled (cardiac, pulmonary, renal, liver decompensation...) visceral failure, in the 6 months preceding the study * Visceral metastases or peritoneal carcinosis * History of cancers except if remission for more than 3 years, in-situ cancer, epidermoid or baso-cellular cancer * Metal biliary prothesis non extractable * Patient with history of epileptic events * History of myocard infarction for less than 6 months * Unstabilised coronary disease for at least 6 months * Cardiac rhythm trouble or QT space above 550ms without treatment * Patient eligible to liver transplant * Patient naive of chemiotherapy * Patient with a pacemaker, an implanted automatic defibrillator or an automatic electronic device or an electronic device with metal pieces * Patient with contra-indication to the use of NanoKnife system * History of hypersensitivity to gadolinium or to iodized contrast product not allowing a suitable radiologic monitoring * Refusal or language or psychic incapacity to sign the informed consent * Subject who cannot submit to the constraints of the protocol (subjects for which an MRI or a scan is contra-indicated, claustrophobic subjects, non cooperative or not able to come to the follow-up visits) * Concomitant participation to another study * Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection. * Women at age to procreate and not using effective contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success rate of the technique, being the realisation of the irreversible electroporation. | At Day 0 | The study will be considered positive if the success rate is above 90% and the complication rate below or equal to 30% |
Outcome results
None listed