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

NCT ID: NCT04717687

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-06-01

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.

Conditions

Cholangiocarcinoma; Interventional Imaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electrodes

Electrodes

Group Type: EXPERIMENTAL

Irreversible electroporation

Intervention Type: PROCEDURE

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.

Interventions

Irreversible 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sport & Collection 2019

UNKNOWN

Sponsor Role: collaborator

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HOPE

Identifier Type: -

Identifier Source: org_study_id