Clinical trial NCT03769753: Trial of IRE in Cholangiocarcinoma
Official title: Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangiocarcinoma
Keywords: intraoperative use of IRE
18-489
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-center phase I study.
Primary purpose: TREATMENT

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 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%

Primary outcomes:
measure: Number of Patients Experiencing a Clinically Relevant Complications
timeFrame: within 30 days post-IRE
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
state: New Jersey
city: Middletown
country: United States
facility: Memoral Sloan Kettering Monmouth (Consent and Follow up)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Follow up)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent and Follow up)
state: New York
city: Harrison
country: United States
facility: Memoral Sloan Kettering Westchester (Consent and Follow Up)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and Follow-up)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: T. Peter Kingham, MD
role: PRINCIPAL_INVESTIGATOR
References: