Trial of IRE in Cholangiocarcinoma

Completed · Phase 2

Conditions studied: Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT03769753

Run by

Memorial Sloan Kettering Cancer Center

People needed

8

Starts

2018-12-05

Expected to finish

2021-08-16

Last updated by the study team

2022-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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%

Where it is running

• Memoral Sloan Kettering Basking Ridge (Consent and Follow up) — Basking Ridge, New Jersey, United States
• Memoral Sloan Kettering Monmouth (Consent and Follow up) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Consent and Follow up) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack (Consent and Follow up) — Commack, New York, United States
• Memoral Sloan Kettering Westchester (Consent and Follow Up) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent and Follow-up) — Rockville Centre, New York, United States

Full record on ClinicalTrials.gov

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