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

Étude Pilote de l'évaluation de la Technique de l'électroporation irréversible Dans le Cholangiocarcinome Infiltrant périhilaire

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.

Study Overview

• Status: Withdrawn
• Conditions: Cholangiocarcinoma; Interventional Imaging
• Intervention / Treatment: Procedure: Irreversible electroporation

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrodes	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of the technique, being the realisation of the irreversible electroporation.	The study will be considered positive if the success rate is above 90% and the complication rate below or equal to 30%	At Day 0

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Collaborators: Sport & Collection 2019

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cholangiocarcinoma; Irreversible electroporation; Interventional radiology
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: HOPE (Other Identifier: Ossium Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No