Digestive and General Surgery Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain.
Research Group of Hepato-Biliary and Pancreatic Diseases, Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, University of Barcelona, L'Hospitalet DE Llobregat, Barcelona, Spain.
Medicine (Baltimore). 2023 May 19;102(20):e33853. doi: 10.1097/MD.0000000000033853.
Acute pancreatitis is a high-incidence benign disease. In 2009, it was the second highest cause of total hospital stays, the largest contributor to aggregate costs (approximately US$ 7000.00 per hospitalization), and the fifth leading cause of in-hospital deaths in the United States. Although almost 80% of acute pancreatitis cases are mild (usually requiring short-term hospitalization and without further complications), severe cases can be quite challenging.Classifications, scores, and radiological criteria have been developed to predict disease severity and outcome accurately; however, in-hospital care remains of widespread use, regardless of disease severity. A recent Turkish study reported that mild acute pancreatitis can be effectively and safely managed with home monitoring. Although the optimal timing for oral refeeding remains controversial and could cast some doubt on the feasibility of home monitoring, some guidelines already advocate for starting it within 24 hours.The present clinical trial aims to assess whether home monitoring is effective, safe and non-inferior to hospitalization for managing mild acute pancreatitis.
This will be a multicenter open-label randomized (1:1) controlled clinical trial to assess the efficacy and safety of home monitoring compared to in-hospital care for mild acute pancreatitis. All patients coming to the emergency department with suspected acute pancreatitis will be screened for enrollment. The main variable will be treatment failure (Yes/No) within the first 7 days after randomization.
Acute pancreatitis implies a high economic burden in healthcare systems worldwide. Recent evidence suggests that mild disease can be safely and effectively treated with home monitoring. This approach may produce considerable cost savings and positively impact patients' quality of life. We expect the results to show that home monitoring is effective and not inferior to hospitalization for managing mild acute pancreatitis and that the economic costs are lower, kickstarting similar trials throughout the world, optimizing the use of limited healthcare budgets, and improving patients' quality of life.
急性胰腺炎是一种高发的良性疾病。2009 年，它是总住院时间的第二大主要原因，是总费用（每次住院约 7000.00 美元）的最大贡献者，也是美国住院死亡的第五大主要原因。虽然近 80%的急性胰腺炎病例为轻度（通常需要短期住院，无进一步并发症），但重度病例可能极具挑战性。为了准确预测疾病的严重程度和结局，已经开发出分类、评分和影像学标准；然而，住院治疗仍然广泛使用，而不管疾病的严重程度如何。最近的一项土耳其研究报告称，轻度急性胰腺炎可以通过家庭监测进行有效和安全的管理。尽管口服重新喂养的最佳时机仍存在争议，并且可能对家庭监测的可行性产生一些怀疑，但一些指南已经主张在 24 小时内开始进行。本临床试验旨在评估家庭监测在管理轻度急性胰腺炎方面是否有效、安全且不劣于住院治疗。
这将是一项多中心、开放标签、随机（1:1）对照临床试验，旨在评估家庭监测与住院治疗轻度急性胰腺炎的疗效和安全性。所有因疑似急性胰腺炎而到急诊科就诊的患者都将进行入组筛查。主要变量将是随机分组后第 7 天内的治疗失败（是/否）。
急性胰腺炎在全球医疗保健系统中意味着很高的经济负担。最近的证据表明，轻度疾病可以通过家庭监测安全有效地治疗。这种方法可能会产生可观的成本节约，并对患者的生活质量产生积极影响。我们预计结果将表明家庭监测在管理轻度急性胰腺炎方面是有效且不劣于住院治疗，并且经济成本更低，从而在全球范围内启动类似的试验，优化有限的医疗保健预算的使用，并提高患者的生活质量。
