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

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ClinicalTrials.gov Identifier: NCT04717687
Recruitment Status : Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Sport & Collection 2019
Information provided by (Responsible Party):
Poitiers University Hospital

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Interventional Imaging Procedure: Irreversible electroporation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Étude Pilote de l'évaluation de la Technique de l'électroporation irréversible Dans le Cholangiocarcinome Infiltrant périhilaire
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electrodes
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.




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717687


Contacts
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Contact: Jean-Pierre TASU, MD +33.5.49.44.44.32 jean-pierre.tasu@chu-poitiers.fr

Sponsors and Collaborators
Poitiers University Hospital
Sport & Collection 2019
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT04717687    
Other Study ID Numbers: HOPE
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poitiers University Hospital:
Cholangiocarcinoma
Irreversible electroporation
Interventional radiology
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms