Pilot Study on the Evaluation of Irreversible Electroporation Technique in Infiltrating Perihilar Cholangiocarcinoma (HOPE)

Poitiers University Hospital

Status

Withdrawn

Conditions

Cholangiocarcinoma

Interventional Imaging

Treatments

Procedure: Irreversible electroporation

Study type

Interventional

Funder types

Other

Identifiers

NCT04717687

HOPE

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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