Trial of IRE in Cholangiocarcinoma

Study Overview
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Brief Summary
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The purpose of this study is to test any good and bad side effects of surgery using IRE to treat cancer of the bile duct.

Official Title
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Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase II

Conditions
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Cholangiocarcinoma

Intervention / Treatment
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* Device: IRE Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Capable of providing written and oral informed consent in English Locally advanced disease based on preoperative work-up demonstrating that the tumor is unresectable due to portal vein, hepatic artery, and/or bile duct involvement, insufficient hypertrophy response of the future liver remnant after portal vein embolization, or patients not able to tolerate major liver surgery Found to be unresectable intraoperatively based on vascular, biliary, or lymph node (N2) involvement upon exploratory laparotomy Patients will be assessed for chemotherapy prior to treatment with IRE, but given the common problem of recurrent cholangitis, some patients will not be candidates for chemotherapy until after IRE is performed. Exclusion Criteria: Locally advanced PHC eligible and accepted for liver transplantation evaluation PHC with > 5 cm extension along the common hepatic duct or common bile duct on preoperative imaging or intraoperative ultrasound Metastases to peritoneum, liver or other organs confirmed by percutaneous biopsy, staging laparoscopy or intraoperative frozen section Lymph node metastases beyond N2 stations, confirmed by intraoperative frozen sections or radiographic diagnosis History of cardiac disease: Congestive heart failure (NYHA class >2) Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening) Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted) Any implanted stimulation device (defined as implantable cardiac device and a pacemaker) Uncontrolled hypertension (blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen) Uncontrolled infections (> grade 2 NCI-CTC, version 3.0) Epilepsy Both narrowing (sclerosis) of the main portal vein and a reduced diameter of either the common hepatic artery, celiac trunk or superior mesenteric artery of >50%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, single-center phase I study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intraoperative use of IRE<br>Patients with intraoperatively determined advanced unresectable PHC will be treated with IRE during the same surgical exploration session (N=20). Electrodes will be placed using ultrasound guidance. All electrodes will be placed by hepatopancreatobiliary surgeons with experience using IRE. | Device: IRE Device<br>* For use in ablating soft tissue<br>* Other names: The NanoKnife IRE device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Experiencing a Clinically Relevant Complications | defined as CTCAE (version 5.0) grade 3 or higher complications | within 30 days post-IRE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative use of IRE, 18-489