In this study we hope to provide early detection of a treatable cause of pancreatitis by endoscopic ultrasound, and we hope to prevent unnecessary exposure to the rare but serious complications of cholecystectomy. This way, we will be able to…
ID
Bron
Verkorte titel
Aandoening
Pancreatitis
Acute pancreatitis
Idiopathic pancreatitis
Idiopathische pancreatitis
Idiopathic acute pancreatitis
Idiopathische acute pancreatitis
Endoscopic ultrasonography
Endoscopic ultrasound
Endo-echo
Endoscopische echografie
Endoscopische echo
Aetiology
Etiology
Etiologie
Ondersteuning
Head of department Department of Gastroenterology & Hepatology
C2-330
Academic Medical Center
Meibergdreef 9
1105 AZ, Amsterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The amount of patients with idiopathic acute pancreatitis in whom endoscopic ultrasound detects gallstone disease or other causes of pancreatitis (such as chronic pancreatitis or pancreatic tumours).
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Positive imaging is defined as imaging during which a definitive cause for the acute pancreatitis episode can be found; or during which abnormalities are visualized in which, after obtaining tissue and pathological examination, pathological tissue is found.
Achtergrond van het onderzoek
Idiopathic acute pancreatitis (IAP) remains a dilemma for many physicians as it is unclear to what extent additional diagnostic modalities such as endoscopic ultrasound (EUS) are warranted after a first episode of IAP in order to determine an aetiology. The aim of the PICUS study is to determine the value of EUS in patients with a first episode of IAP with regard to determining an aetiology and preventing recurrent pancreatitis.
The PICUS study is designed as a multicentre prospective cohort study of 106 patients with (presumed) idiopathic acute pancreatitis after standard work-up in whom, following the current guidelines (1), an EUS will be performed. If an aetiology is found during endoscopic ultrasonography, patients will receive appropriate treatment in accordance with the current guidelines. Follow-up will be 12 months, during which patients will be asked to fill out a questionnaire at baseline, six months and 12 months after inclusion. The primary outcome measure is detection of aetiology by EUS. Secondary outcome measures are recurrence rate, severity of recurrent pancreatitis, readmission, additional interventions, complications, length of hospital stay, quality of life, mortality and costs.
The PICUS study will potentially improve the diagnostic process in “presumed” IAP patients, lower recurrence rate, avoid unnecessary interventions and positively impact quality of life of pancreatitis patients.
Doel van het onderzoek
In this study we hope to provide early detection of a treatable cause of pancreatitis by endoscopic ultrasound, and we hope to prevent unnecessary exposure to the rare but serious complications of cholecystectomy. This way, we will be able to prevent readmissions as well as complications and directly improve health and quality of life of the patient.
Onderzoeksopzet
The primary outcome measure will be evaluated during endoscopic ultrasound, or, if applicable, after pathology reports of histological or cytological specimens have become available.
Questionnaires (Short Form-36) will be filled out after inclusion, at six months and at 12 months.
The other secondary outcome measures will be evaluated at 12 months after inclusion.
Onderzoeksproduct en/of interventie
Endoscopic ultrasound
Publiek
Devica Umans
Amsterdam
The Netherlands
d.umans@pancreatitis.nl
Wetenschappelijk
Devica Umans
Amsterdam
The Netherlands
d.umans@pancreatitis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients older than 18 years
2. First episode of idiopathic acute pancreatitis
3. Informed consent for participation
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients in whom an aetiology is found in standard work-up
2. Diagnosis of chronic pancreatitis (according to the M-ANNHEIM classification) in standard work-up
3. Recurrent pancreatitis
4. Altered anatomy which prohibits the endoscopist from visualizing gall bladder, bile ducts, pancreas or pancreatic duct via endoscopic ultrasound (such as gastric bypass surgery)
5. Patients in which an endoscopic ultrasound is performed before inclusion, either during or after the index admission
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL7066 |
NTR-old | NTR7264 |
Ander register | METC AMC : W18_161 |