Trial of IRE in Cholangiocarcinoma

Phase 2

Completed

• Conditions: Cholangiocarcinoma
• Interventions: Device: IRE Device

• Registration Number: NCT03769753
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-12-05
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Primary Completion: 2021-08-16
• Study Completion: 2021-08-16
• Status Verified: 2022-08
• Results First Submitted: 2022-08-16
• Results First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Results First Posted: 2022-09-10
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Read More

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%

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intraoperative use of IRE	IRE Device	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients Experiencing a Clinically Relevant Complications	within 30 days post-IRE	defined as CTCAE (version 5.0) grade 3 or higher complications

Trial Locations

Locations (7)

Memoral Sloan Kettering Basking Ridge (Consent and Follow up); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent and Follow up); 🇺🇸 Montvale, New Jersey, United States

Memoral Sloan Kettering Monmouth (Consent and Follow up); 🇺🇸 Middletown, New Jersey, 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 Commack (Consent and Follow up); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Nassau (Consent and Follow-up); 🇺🇸 Rockville Centre, New York, United States