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

Cholangiocarcinoma Clinical Trial

— HOPE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04717687
• Other study ID #: HOPE
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2022
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Interventional Imaging

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	Sport & Collection 2019

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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