Trial of IRE in Cholangiocarcinoma

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Cholangiocarcinoma

Treatments: Device: IRE Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03769753

18-489

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

intraoperative use of IRE

Experimental group

Description:

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.

Treatment:

Device: IRE Device