Status:
COMPLETED
Trial of IRE in Cholangiocarcinoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03769753
Start Date
December 5 2018
End Date
August 16 2021
Last Update
September 10 2022
Active Locations (7)
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1
Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
Basking Ridge, New Jersey, United States, 07920
2
Memoral Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Consent and Follow up)
Commack, New York, United States, 11725