Home care/outpatient versus hospital admission in mild acute pancreatitis: protocol of a multicentre, randomised controlled trial (PADI_2 trial)

Abstract

IntroductionAcute pancreatitis (AP) is the third most common gastrointestinal disease resulting in hospital admission, with over 70% of AP admissions being mild cases. In the USA, it costs 2.5 billion dollars annually. The most common standard management of mild AP (MAP) still is hospital admission. Patients with MAP usually achieve complete recovery in less than a week and the severity predictor scales are reliable. The aim of this study will be to compare three different strategies for the management of MAP.Methods/designThis is a randomised, controlled, three-arm multicentre trial. Patients with MAP will be randomly assigned to group A (outpatient), B (home care) or C (hospital admission). The primary endpoint of the trial will be the treatment failure rate of the outpatient/home care management for patients with MAP compared with that of hospitalised patients. The secondary endpoints will be pain relapse, diet intolerance, hospital readmission, hospital length of stay, need for intensive care unit admission, organ failure, complications, costs and patient satisfaction. The general feasibility, safety and quality checks required for high-quality evidence will be adhered to.Ethics and disseminationThe study (version 3.0, 10/2022) has been approved by the Scientific and Research Ethics Committee of the ‘Institut d’Investigació Sanitaria Pere Virgili-IISPV’ (093/2022). This study will provide evidence as to whether outpatient/home care is similar to usual management of AP. The conclusions of this study will be published in an open-access journal.Trial registration numberClinicalTrials.gov Registry (NCT05360797).