Evaluating the safety of percutaneous primary and secondary biliary stenting as palliative treatments for unresectable malignant biliary obstructions: an open label, randomized and controlled non-inferiority safety clinical trial

Abstract

Background: Malignant biliary obstructions (MBO) involve different biliopancreatic and metastatic neoplasms that show-up with late or unspecific symptoms, leading to a differed diagnosis and dismal prognosis. These patients present debilitating symptoms and complications, related to hyperbilirubinemia, which is also a criterion to contraindicate chemotherapy. Percutaneous biliary stenting (PBS), which can be done as primary stenting (PS) or secondary stenting (SS), has demonstrated to improve clinical outcomes and patient’s quality of life (QoL). Even though there is some evidence positioning PS as a safer technique than SS, with equivalent efficacy, current clinical practice is still based on SS. Objectives: The purpose of this study is to evaluate and compare the occurrence and severity of complications, technical and clinical success, total time of hospitalization, and QoL in patients with unresectable MBO undergoing PS or SS as palliative treatments. Design: This study is designed as a single-institution, prospective, open-label, randomized and controlled non-inferiority safety clinical trial, developed from November 2022 to August 2027 at the Interventional Radiology Department of Consorci Corporació Sanitària Parc Taulí (CCSPT). Methods: This clinical trial will enroll 236 patients with unresectable MBO, when endoscopic biliary stenting is not feasible or fails, who will be randomly allocated into PS and SS (ratio 1:1). Technical success will be evaluated during the intervention; clinical success and QoL will be assessed at 3 or 6 weeks after the procedure; occurrence of complications (main outcome), severity of complications, and total time of related hospitalization, will be assessed within the different steps of the procedure and during 30 days after its finalization. Additionally, we will perform an interim analysis to determine the safety of both interventions, and promptly stop the study if futility or extreme beneficence/maleficence is found in any group