Role of endoscopic ultrasonography in the diagnostic work-up of idiopathic acute pancreatitis (PICUS): study protocol for a nationwide prospective cohort study.
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Umans Devica S, Timmerhuis Hester C, Hallensleben Nora D, Bouwense Stefan A, Anten Marie-Paule Gf, Bhalla Abha, Bijlsma Rina A, Boermeester Marja A, Brink Menno A, Hol Lieke, Bruno Marco J, Curvers Wouter L, van Dullemen Hendrik M, van Eijck Brechje C, Erkelens G Willemien, Fockens Paul, van Geenen Erwin J M, Hazen Wouter L, Hoge Chantal V, Inderson Akin, Kager Liesbeth M, Kuiken Sjoerd D, Perk Lars E, Poley Jan-Werner, Quispel Rutger, Römkens Tessa Eh, van Santvoort Hjalmar C, Tan Adriaan Citl, Thijssen Annemieke Y, Venneman Niels G, Vleggaar Frank P, Voorburg Annet McJ, van Wanrooij Roy Lj, Witteman Ben J, Verdonk Robert C, Besselink Marc G, van Hooft Jeanin E, Dutch Pancreatitis Study Group
Аннотация
METHODS AND ANALYSIS: PICUS is designed as a multicentre prospective cohort study of 106 patients with a first episode of IAP after complete standard diagnostic work-up, in whom a diagnostic EUS will be performed. Standard diagnostic work-up will include a complete personal and family history, laboratory tests including serum alanine aminotransferase, calcium and triglyceride levels and imaging by transabdominal ultrasound, magnetic resonance imaging or magnetic resonance cholangiopancreaticography after clinical recovery from the acute pancreatitis episode. The primary outcome measure is detection of aetiology by EUS. Secondary outcome measures include pancreatitis recurrence rate, severity of recurrent pancreatitis, readmission, additional interventions, complications, length of hospital stay, quality of life, mortality and costs, during a follow-up period of 12 months.
ETHICS AND DISSEMINATION: PICUS is conducted according to the Declaration of Helsinki and Guideline for Good Clinical Practice. Five medical ethics review committees assessed PICUS (Medical Ethics Review Committee of Academic Medical Center, University Medical Center Utrecht, Radboud University Medical Center, Erasmus Medical Center and Maastricht University Medical Center). The results will be submitted for publication in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER: Netherlands Trial Registry (NL7066). Prospectively registered.