TY - JOUR
T1 - Role of endoscopic ultrasonography in the diagnostic work-up of idiopathic acute pancreatitis (PICUS)
T2 - study protocol for a nationwide prospective cohort study
AU - Umans, Devica S
AU - Timmerhuis, Hester C
AU - Hallensleben, Nora D
AU - Bouwense, Stefan A
AU - Anten, Marie-Paule Gf
AU - Bhalla, Abha
AU - Bijlsma, Rina A
AU - Boermeester, Marja A
AU - Brink, Menno A
AU - Hol, Lieke
AU - Bruno, Marco J
AU - Curvers, Wouter L
AU - van Dullemen, Hendrik M
AU - van Eijck, Brechje C
AU - Erkelens, G Willemien
AU - Fockens, Paul
AU - van Geenen, Erwin J M
AU - Hazen, Wouter L
AU - Hoge, Chantal V
AU - Inderson, Akin
AU - Kager, Liesbeth M
AU - Kuiken, Sjoerd D
AU - Perk, Lars E
AU - Poley, Jan-Werner
AU - Quispel, Rutger
AU - Römkens, Tessa Eh
AU - van Santvoort, Hjalmar C
AU - Tan, Adriaan Citl
AU - Thijssen, Annemieke Y
AU - Venneman, Niels G
AU - Vleggaar, Frank P
AU - Voorburg, Annet McJ
AU - van Wanrooij, Roy Lj
AU - Witteman, Ben J
AU - Verdonk, Robert C
AU - Besselink, Marc G
AU - van Hooft, Jeanin E
N1 - Publisher Copyright:
©
PY - 2020/8/20
Y1 - 2020/8/20
N2 - 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.
AB - 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.
KW - endoscopy
KW - hepatobiliary disease
KW - pancreatic disease
UR - https://www.scopus.com/pages/publications/85089769478
U2 - 10.1136/bmjopen-2019-035504
DO - 10.1136/bmjopen-2019-035504
M3 - Article
C2 - 32819938
SN - 2044-6055
VL - 10
SP - e035504
JO - BMJ Open
JF - BMJ Open
IS - 8
M1 - e035504
ER -