1. Role of endoscopic ultrasonography in the diagnostic work-up of idiopathic acute pancreatitis (PICUS): study protocol for a nationwide prospective cohort study.
- Author
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Umans DS, Timmerhuis HC, Hallensleben ND, Bouwense SA, Anten MG, Bhalla A, Bijlsma RA, Boermeester MA, Brink MA, Hol L, Bruno MJ, Curvers WL, van Dullemen HM, van Eijck BC, Erkelens GW, Fockens P, van Geenen EJM, Hazen WL, Hoge CV, Inderson A, Kager LM, Kuiken SD, Perk LE, Poley JW, Quispel R, Römkens TE, van Santvoort HC, Tan AC, Thijssen AY, Venneman NG, Vleggaar FP, Voorburg AM, van Wanrooij RL, Witteman BJ, Verdonk RC, Besselink MG, and van Hooft JE
- Subjects
- Acute Disease, Humans, Multicenter Studies as Topic, Netherlands, Prospective Studies, Quality of Life, Endosonography, Pancreatitis diagnostic imaging
- Abstract
Introduction: Idiopathic acute pancreatitis (IAP) remains a dilemma for physicians as it is uncertain whether patients with IAP may actually have an occult aetiology. It is unclear to what extent additional diagnostic modalities such as endoscopic ultrasonography (EUS) are warranted after a first episode of IAP in order to uncover this aetiology. Failure to timely determine treatable aetiologies delays appropriate treatment and might subsequently cause recurrence of acute pancreatitis. Therefore, the aim of the Pancreatitis of Idiopathic origin: Clinical added value of endoscopic UltraSonography (PICUS) Study is to determine the value of routine EUS in determining the aetiology of pancreatitis in patients with a first episode of IAP., 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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2020
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