Ablation with irreversible electroporation in patients with advanced perihilar cholangiocarcinoma - a multicenter phase I/II safety study

Phase 2

Completed

• Conditions: Klatskin tumor; perihilar bile duct tumor; Perihilar cholangiocarcinoma; 10019654

• Registration Number: NL-OMON50469
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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

* 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 (<6 maanden)
* 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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is safety, defined as the total number of clinically<br /><br>relevant complications (Common Terminology Criteria for Adverse Events [CTCAE],<br /><br>score of 3 or higher) within 90 days post-IRE.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the success rate of completing IRE, intra-procedural<br /><br>complications related to IRE, duration of hospital stay, quality of life,<br /><br>impact of IRE on post-procedural CT imaging and blood biomarker response, time<br /><br>between IRE and start of palliative chemotherapy, metal stent patency,<br /><br>progression-free and overall survival.</p><br>