Visceral Debranching Followed by Neoadjuvant Chemotherapy and Pancreatic Resection for Locally Advanced Pancreatic Cancer: A Phase II Clinical Trial

Abstract

Introduction: Advances in multimodal treatment have led to an increasing number of complex operations for pancreatic cancer . For locally advanced tumors with arterial invasion, only resection with arterial reconstruction offers a chance of cure. However, simultaneous arterial reconstruction and tumor resection is associated with high morbidity and mortality. The study aims to assess feasibility of a novel approach of performing visceral debranching, i. e. arterial reconstruction, prior to neoadjuvant chemotherapy and tumour resection in locally advanced pancreatic cancer. All open vascular procedures can be considered. Examples are aorto-visceral or iliaco-visceral bypasses. Method: The trial is designed as a single-arm multi-center study. After confirming eligibility for pancreatic resection with arterial reconstruction in a multidisciplinary tumor board, patients are offered trial enrolment. At first, patients proceed to undergo visceral debranching. Once the patient has sufficiently recovered from the procedure, neoadjuvant chemotherapy starts. Tumor resection is performed four to six weeks after completion of chemotherapy. After treatment, patients are followed up. The primary outcome is feasibility, measured as the proportion of patients who start neoadjuvant therapy within six weeks of visceral debranching. Using an exact single-stage design (H0=0.7, H1=0.9, alpha=0.05 1-beta=0.8), feasibility of the approach under study is assumed if 24 of the enrolled 28 patients proceed to neoadjuvant chemotherapy. Conclusion: This trial evaluates the feasibility of visceral debranching prior to neoadjuvant chemotherapy and tumor resection in order to avoid the relevant morbidity and mortality associated with simultaneous resection and reconstruction.