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Trial of IRE in Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03769753
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Device: IRE Device Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective, single-center phase I study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase II
Actual Study Start Date : December 5, 2018
Actual Primary Completion Date : August 16, 2021
Actual Study Completion Date : August 16, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: IRE Device
For use in ablating soft tissue
Other Name: The NanoKnife IRE device


Outcome Measures
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Primary Outcome Measures :
  1. proportion of patients experiencing a clinically relevant complications [ Time Frame: within 30 days post-IRE ]
    defined as CTCAE (version 5.0) grade 3 or higher complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769753


Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
Basking Ridge, New Jersey, United States, 07920
Memoral Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack (Consent and Follow up)
Commack, New York, United States, 11725
Memoral Sloan Kettering Westchester (Consent and Follow Up)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau (Consent and Follow-up)
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: T. Peter Kingham, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03769753    
Other Study ID Numbers: 18-489
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
intraoperative use of IRE
18-489
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms