Trial of IRE in Cholangiocarcinoma

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%