从ESCAPE研究探讨胰腺炎临床试验开展的要点

Key points of clinical trials of pancreatitis:enlightenment from ESCAPE study

临床试验是临床研究的重要组成部分。通过临床试验的实施可以获得高级别循证医学证据,指导临床实践。胰腺炎由于疾病的特殊性和复杂性,其临床试验的开展远少于胰腺肿瘤。ESCAPE研究是荷兰胰腺炎研究组发起的一项针对疼痛性慢性胰腺炎患者最佳干预措施的前瞻性、多中心随机对照临床试验,其最新研究结果于2020年发表在《The Journal of the American Medical Association》。ESCAPE研究的试验设计、具体实施和结果分析均可作为业内典范。笔者介绍最新ESCAPE研究结果,对开展胰腺炎临床试验的要点和问题进行总结,旨在促进我国胰腺炎临床试验的普及和规范化开展,提高胰腺领域的国际学术影响力。

The clinical trial is a crucial part of the clinical study.High level medical evidence,getting from the clinical trial,can guide the clinical practice.Compared with pancreatic cancer,the number of clinical trials of pancreatitis is still less as it is a special and complicated disease.The ESCAPE study,initiated by the Dutch pancreatitis research group,was a prospective,multicenter,randomized clinical trial to find the best approach for patients with painful chronic pancreatitis.The results of ESCAPE study were published on the Journal of the American Medical Association in 2020.ESCAPE study is a paradigm for clinical trial of pancreatitis from trial design,study implementation and result analysis.This paper not only focuses on the latest results of ESCAPE study,but also summarizes the key points and problems of clinical trials of pancreatitis.It is extremely urgent to launch clinical trials of pancreatitis widely and canonically,which is helpful to increase the influence of China in the field of pancreas.