Pancreatitis post-CPRE: ¿precorte temprano o prótesis pancreática? Ensayo aleatorizado, multicéntrico y análisis de coste-efectividad

espanolIntroduccion: la pancreatitis es la complicacion mas frecuente de la colangiopancreatografia retrograda endoscopica (CPRE). La colocacion de una protesis pancreatica es una medida preventiva. Hay evidencias, tambien, sobre el efecto protector que tendria la realizacion de un precorte temprano en los casos con canulacion dificil. Objetivo: determinar y comparar el coste-efectividad entre la realizacion de precorte temprano y colocacion de una protesis pancreatica en la prevencion de pancreatitis post-CPRE. Metodos: estudio piloto, prospectivo, aleatorizado, multicentrico y analisis de coste-efectividad entre precorte temprano (grupo A) y protesis pancreatica (grupo B) en la prevencion de pancreatitis en pacientes de alto riesgo. Se incluyeron pacientes con canulacion biliar dificultosa y otros factores de riesgo de pancreatitis. Se analizaron la efectividad y el coste de los procedimientos y sus complicaciones. Resultados: durante dos anos se incluyeron 101 pacientes y se aleatorizaron 50 sujetos en el grupo de precorte y 51 sujetos en el grupo de protesis. No hubo diferencias en las caracteristicas demograficas de los participantes ni en las indicaciones del estudio. Se registraron dos pancreatitis leves en cada grupo. El coste fue de 1.242,6$ por paciente en el grupo A y 1.606,5$ por paciente en el grupo B. El coste del grupo B fue un 29,3% mayor (p Conclusiones: el precorte temprano es mas coste-eficaz que la protesis pancreatica en la prevencion de pancreatitis post-CPRE. EnglishBackground: Pancreatitis is the most frequent complication due to ERCP. Pancreatic duct stent placement has been described as a preventive measure. There is also evidence pointing towards the preventive effect that early precut may provide. Aim: To determine and compare the cost-effectiveness of an early precut approach versus pancreatic duct stent placement for the prevention of post-ERCP pancreatitis. Methods: This was a multicenter, randomized-controlled pilot study with a cost-effectiveness analysis performed between early precut (group A) and pancreatic duct stent (group B) for the prevention of pancreatitis in high-risk patients. Patients with a difficult biliary cannulation and at least one other risk factor for post-ERCP pancreatitis were enrolled and randomized to one of the treatment arms. Both effectiveness and costs of the procedures and their complications were analyzed and compared. Results: From November 2011 to November 2013, 101 patients were enrolled; 50 subjects were assigned to group A and 51 to group B. There were no significant differences in terms of baseline characteristics of patients between groups. Two cases of mild pancreatitis were observed in each group. The overall costs were U$ 1,242.6 per patient in group A and U$ 1,606.5 per patient in group B. The cost in group B was 29.3% higher (p Conclusion: Early precut showed a better cost-effectiveness profile when compared to pancreatic duct stent placement.