Klatskin tumor perihilar bile duct tumor Perihilar cholangiocarcinoma
Conditions
Interventions
Computed tomography-guided percutaneous IRE (N=11)
Open IRE (N=1), inclusion in this group closed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age 18 years or older * Capable of providing written and oral informed consent * WHO *2 * Meets criteria for advanced PHC o Local recurrent disease localized on the distal bile duct remnant, hepatico-jejunostomy or in the liver hilum without N2 lymph nodes or distant metastases . * Diagnosis of PHC or lymph node metastases must be confirmed with endoscopic brush, percutaneous- or laparoscopic biopsy, whichever is suitable, o Vascular or lymph node (N2) involvement on imaging or during staging laparoscopy Diagnosis of PHC or lymph node metastases beyond N2 stations must be confirmed with endoscopic brush, percutaneous- or laparoscopic biopsy, whichever is suitable o Vascular or lymph node (N2) involvement during exploratory laparotomy Must be confirmed with intra-operative frozen section
Exclusion criteria
Exclusion criteria: * Resectable PHC upon exploratory laparotomy * Locally advanced PHC eligible for liver transplantation (Appendix 3) * PHC with > 5 cm extension along the common hepatic duct or common bile duct * Metastases to peritoneum, liver or other organs confirmed by percutaneous biopsy, staging laparoscopy or intraoperative frozen section * Lymph node metastases beyond N2 stations (e.g. inguinal, mediastinal) * History of cardiac arrhythmia*s (any of the following) o Sinus tachycardia (BPM>100) o Sick sinus syndrome o Sinoatrial exit block o AV block o Sinus node reentry o Presence of a pacemaker or defibrillator * Recent history of myocardial infarction ( grade 2 NCI-CTC, version 3.0) * Epilepsy * Both narrowing (sclerosis) of the portal vein and a reduced diameter of either the common hepatic artery, celiac trunk or superior mesenteric artery of >50% * Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is safety, defined as the total number of clinically relevant complications (Common Terminology Criteria for Adverse Events [CTCAE], score of 3 or higher) within 90 days post-IRE. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the success rate of completing IRE, intra-procedural complications related to IRE, duration of hospital stay, quality of life, impact of IRE on post-procedural CT imaging and blood biomarker response, time between IRE and start of palliative chemotherapy, metal stent patency, progression-free and overall survival. | — |
Countries
Netherlands
Outcome results
None listed