Acute biliary pancreatitis (ABP) is a common disease associated with substantial healthcare expenditure and a tendency to recur if early cholecystectomy is not performed. In Spanish hospitals, surgical waiting lists often delay cholecystectomy for several months, exposing patients to a high probability (20–25%) of complications related to biliary lithiasis. This leads patients to experience avoidable complications which, in addition to their associated morbidity and mortality, generate significant frustration and dissatisfaction with the healthcare system. A hospital admission for a new episode of pancreatitis or acute cholecystitis costs approximately 5,000 and 8,000 euros, respectively, according to U.S. data. Ursodeoxycholic acid (UDCA) has been shown to dissolve cholesterol gallstones, but its ability to reduce the incidence of biliary complications in this specific context has not been rigorously evaluated. The present study is a multicenter, double‑blind, randomized, placebo‑controlled clinical trial. Patients experiencing a first episode of ABP will be randomized to receive UDCA or placebo. The primary objective is to determine whether UDCA reduces the incidence of death or biliary‑lithiasis–related complications (acute pancreatitis, biliary colic, cholecystitis, cholangitis, or choledocholithiasis). Secondary objectives include evaluating the individual components of the primary endpoint, healthcare resource utilization, the effect of the medication on gallbladder lithiasis, and quality of life.
Project impact and health-related aspects: surgical waiting lists are a structural reality that is difficult to improve. However, if a safe and inexpensive medication were available that could spare a proportion of patients from the morbidity and mortality associated with recurrent biliary complications—and spare the healthcare system the associated resource use and costs—the overall efficiency of the process would increase.
With only a one‑month delay in cholecystectomy, according to the PONCHO clinical trial (Da Costa, Lancet 2015), 17% of patients develop biliary complications (including 9% with recurrent acute biliary pancreatitis, ABP). Reducing this incidence by half through the administration of UDCA for six months would save the healthcare system more than 14,000 euros per 100 patients with ABP—considering only the prevention of recurrent ABP (UDCA may also reduce the incidence of other biliary complications). The study aims to improve the efficiency of the healthcare system without significant resource consumption, reducing patient suffering, system overload, and costs. We propose a high‑quality phase III clinical trial, designed by a group with strong leadership in this field and extensive experience in similar studies. A high‑impact publication is expected, with immediate applicability to real‑world clinical practice and likely to be widely cited by other articles and clinical practice guidelines.
Relationship with the scientific and social policies of the call: this is a clinical trial involving a non‑patented, low‑cost drug (approximately 15 euros per month), with no commercial interest, and strongly oriented toward generating evidence to support its implementation within the national health system.
