Cholangiocarcinoma
Conditions
Keywords
intraoperative use of IRE, 18-489
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.
Interventions
DEVICEIRE Device
For use in ablating soft tissue
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-center phase I study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Experiencing a Clinically Relevant Complications | within 30 days post-IRE | defined as CTCAE (version 5.0) grade 3 or higher complications |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intraoperative Use of IRE 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.
IRE Device: For use in ablating soft tissue | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inevaluable - No Evidence of Disease | 1 |
| Overall Study | Not Treated | 6 |
Baseline characteristics
| Characteristic | Intraoperative Use of IRE |
|---|---|
| Age, Continuous | 72 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 8 |
| other Total, other adverse events | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Number of Patients Experiencing a Clinically Relevant Complications
defined as CTCAE (version 5.0) grade 3 or higher complications
Time frame: within 30 days post-IRE
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intraoperative Use of IRE | Number of Patients Experiencing a Clinically Relevant Complications | Number of participants with grade 3 or higher complications | 1 Participants |
| Intraoperative Use of IRE | Number of Patients Experiencing a Clinically Relevant Complications | Number of participants not evaluated for complications | 7 Participants |