Trial of IRE in Cholangiocarcinoma

NCT03769753 | Completed Phase 2 Results FDA Device

• 1 other identifier: 18-489
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 7

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.

Conditions

Cholangiocarcinoma

Keywords

intraoperative use of IRE; 18-489

Outcome Measures

Primary Outcomes (1)

• Number of Patients Experiencing a Clinically Relevant Complications

  defined as CTCAE (version 5.0) grade 3 or higher complications

  within 30 days post-IRE

Study Arms (1)

intraoperative use of IRE

EXPERIMENTAL

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.

Device: IRE Device

Interventions

IRE Device DEVICE

For use in ablating soft tissue

Also known as: The NanoKnife IRE device

intraoperative use of IRE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memoral Sloan Kettering Basking Ridge (Consent and Follow up)

Basking Ridge, New Jersey, 07920, United States

Location

Memoral Sloan Kettering Monmouth (Consent and Follow up)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent and Follow up)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent and Follow up)

Commack, New York, 11725, United States

Location

Memoral Sloan Kettering Westchester (Consent and Follow Up)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent and Follow-up)

Rockville Centre, New York, 11570, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: T. Peter Kingham, MD
• Organization: Memorial Sloan Kettering Cancer Center

kinghamp@mskcc.org

212-639-5260

Study Officials

• T. Peter Kingham, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center phase I study.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: December 5, 2018
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: September 10, 2022
• Results First Posted: September 10, 2022

Record last verified: 2022-08

Locations

US (7)