Ablation with irreversible electroporation in patients with advanced perihilar cholangiocarcinoma (ALPACA): a multicentre phase I/II feasibility study protocol.

Abstract

INTRODUCTION:

The majority of patients with perihilar cholangiocarcinoma (PHC) has locally advanced disease or distant lymph node metastases on presentation or exploratory laparotomy, which makes them not eligible for resection. As the prognosis of patients with locally advanced PHC or lymph node metastases in the palliative setting is significantly better compared with patients with organ metastases, ablative therapies may be beneficial. Unfortunately, current ablative options are limited. Photodynamic therapy causes skin phototoxicity and thermal ablative methods, such as stereotactic body radiation therapy and radiofrequency ablation, which are affected by a heat/cold-sink effect when tumours are located close to vascular structures, such as the liver hilum. These limitations may be overcome by irreversible electroporation (IRE), a relatively new ablative method that is currently being studied in several other soft tissue tumours, such as hepatic and pancreatic tumours.

METHODS AND ANALYSIS:

In this multicentre phase I/II safety and feasibility study, 20 patients with unresectable PHC due to vascular or distant lymph node involvement will undergo IRE. Ten patients who present with unresectable PHC will undergo CT-guided percutaneous IRE, whereas ultrasound-guided IRE will be performed in 10 patients with unresectable tumours detected at exploratory laparotomy. The primary outcome is the total number of clinically relevant complications (Common Terminology Criteria for Adverse Events, score of≥3) within 90 days. Secondary outcomes include quality of life, tumour response, metal stent patency and survival. Follow-up will be 2 years.

ETHICS AND DISSEMINATION:

The protocol has been approved by the local ethics committees. Data and results will be submitted to a peer-reviewed journal.

CONCLUSION:

The Ablation with irreversible eLectroportation in Patients with Advanced perihilar CholangiocarcinomA (ALPACA) study is designed to assess the feasibility of IRE for advanced PHC. The main purpose is to inform whether a follow-up trial to evaluate safety and effectiveness in a larger cohort would be feasible.

• Authors: Robert J S Coelen, Jantien A Vogel, Laurien G P H Vroomen, Eva Roos, Olivier R C Busch, Otto M van Delden, Foke van Delft, Michal Heger, Jeanin E van Hooft, Geert Kazemier, Heinz-Josef Klümpen, Krijn P van Lienden, Erik A J Rauws, Hester J Scheffer, Henk M Verheul, Jan de Vries, Johanna W Wilmink, Barbara M Zonderhuis, Marc G Besselink, Thomas M van Gulik, Martijn R Meijerink
• Journal: BMJ open (BMJ Open) Vol. 7 Issue 9 Pg. e015810 (Sep 01 2017) ISSN: 2044-6055 [Electronic] England
• PMID: 28864693 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Bile Duct Neoplasms (therapy)
• Bile Ducts (pathology, surgery)
• Catheter Ablation (methods)
• Cohort Studies
• Electroporation (methods)
• Feasibility Studies
• Female
• Humans
• Klatskin Tumor (therapy)
• Male
• Middle Aged
• Prospective Studies
• Research Design
• Young Adult