Trial of IRE in Cholangiocarcinoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2021-08-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer

NCT00003276

Gallbladder Cancer

COMPLETED PHASE2

Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer

NCT00002933

Colorectal Cancer

COMPLETED PHASE2

Irinotecan in Treating Patients With Metastatic Colorectal Cancer

NCT00003544

Colorectal Cancer

COMPLETED PHASE2

Monoclonal Antibody Therapy in Treating Patients With Colorectal Cancer

NCT00005616

Colorectal Cancer Metastatic Cancer

COMPLETED PHASE1

ISIS 183750 With Irinotecan for Advanced Solid Tumors or Colorectal Cancer

NCT01675128

Colorectal Neoplasms Colorectal Carcinoma Colorectal Tumors

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholangiocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

IRE Device

Intervention Type DEVICE

For use in ablating soft tissue

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IRE Device

For use in ablating soft tissue

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

The NanoKnife IRE device

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No