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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.
- hepatobiliary tumours
- hepatobiliary disease
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Footnotes
Contributors RJSC, JAV, LGPHV: trial conception and design, drafting and revising the manuscript. ER, ORCB, OMvD, FvD, JEvH, GK, H-JK, KPvL, EAJR, HMV: trial design, revising the manuscript. MH, HJS, JdV, JWW, BMZ: assisting trial design and revising of the manuscript. MGB: trial conception and design, supervising the drafting and revising of the manuscript. TMvG and MRM: principal investigators, trial conception and design, supervising the drafting and revising of the manuscript. All authors read and approved the final manuscript.
Funding The NanoKnife electrodes that will be used in this study are provided by AngioDynamics (Amsterdam-Zuidoost, the Netherlands). The study protocol has not undergone peer review by a funding body.
Competing interests MRM and KPvL are paid educational consultants for AngioDynamics.
Ethics approval The Institutional Review Board (IRB) of the Academic Medical Center in Amsterdam approved the protocol on 19 April 2016. The study has been registered with the Dutch Central Committee on Research Involving Human Subjects (NL56231.018.15). Secondary approval was provided by the local IRB at VU University Medical Center on 14 July 2016.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Trial steering committee: Department of Surgery: ER, GK, TMvG; Department of Radiology: LGPHV, KPvL, MRM; Department of Gastroenterology: JEvH, FvDt; Department of Medical Oncology: H-JK, HMV. ALPACA expert panel: Department of Surgery: MGB, ORCB, GK, TMvGu; Department of Radiology: KPvL, OMvD, MRM; Department of Gastroenterology: JEvH, EAJR, FvD.