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

NCT04717687 | Withdrawn DMC

• 1 other identifier: HOPE
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cholangiocarcinoma; Irreversible electroporation; Interventional radiology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Electrodes

EXPERIMENTAL

Electrodes

Procedure: Irreversible electroporation

Interventions

Irreversible electroporation 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.

Electrodes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• 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
• Signature of the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead
• Sport & Collection 2019: collaborator

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07