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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRE Device | Device | For use in ablating soft tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing a Clinically Relevant Complications | defined as CTCAE (version 5.0) grade 3 or higher complications | within 30 days post-IRE |
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Inclusion Criteria:
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:
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%
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| Name | Affiliation | Role |
|---|---|---|
| T. Peter Kingham, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memoral Sloan Kettering Basking Ridge (Consent and Follow up) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. IRE Device: For use in ablating soft tissue |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. IRE Device: For use in ablating soft tissue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Experiencing a Clinically Relevant Complications | defined as CTCAE (version 5.0) grade 3 or higher complications | Posted | Count of Participants | Participants | within 30 days post-IRE |
|
|
within 30 days post-IRE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. IRE Device: For use in ablating soft tissue |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T. Peter Kingham, MD | Memorial Sloan Kettering Cancer Center | 212-639-5260 | kinghamp@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2020 | Aug 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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This is a prospective, single-center phase I study.
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| Memoral Sloan Kettering Monmouth (Consent and Follow up) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Consent and Follow up) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Consent and Follow up) | Commack | New York | 11725 | United States |
| Memoral Sloan Kettering Westchester (Consent and Follow Up) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Consent and Follow-up) | Rockville Centre | New York | 11570 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 2 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
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| D009369 | Neoplasms |