This study will lead to early and accurate diagnosis of disrupted or disconnected pancreatic duct syndrome or pancreatic fistula in necrotizing pancreatitis. The obtained data will be used to develop a best-practice algorithm for the diagnosis and,…
ID
Bron
Verkorte titel
Aandoening
Acute pancreatitis, acute necrotizing pancreatitis, disconnected pancreatic duct syndrome
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Incidence of disrupted or disconnected pancreatic duct
Achtergrond van het onderzoek
Disrupted or disconnected pancreatic duct syndrome and pancreatic fistula after necrotizing pancreatitis are a clinical dilemma in daily practice. The exact incidence and clinical outcomes are unclear and there is debate on which treatment should follow. The aim of this study is to provide insight in the actual incidence and clinical impact of disrupted or disconnected pancreatic duct syndrome in an unselected cohort of patients with acute necrotizing pancreatitis.
This multicentre prospective observational cohort study will include 98 adult patients with necrotizing pancreatitis. All patients with necrotizing pancreatitis will undergo a predefined, according to the current guidelines, work-up including MRCP. In case of percutaneous drainage, amylase level in drain fluids will be measured routinely. Follow-up will be one year and includes clinical follow-up and patient questionnaires. The primary outcome is incidence of disrupted or disconnected pancreatic duct syndrome and pancreatic fistula. Secondary endpoint is the clinical outcome of patients with and without a disrupted or disconnected pancreatic duct.
Doel van het onderzoek
This study will lead to early and accurate diagnosis of disrupted or disconnected pancreatic duct syndrome or pancreatic fistula in necrotizing pancreatitis. The obtained data will be used to develop a best-practice algorithm for the diagnosis and, eventually, treatment of disrupted or disconnected pancreatic duct syndrome and pancreatic fistula. This will hopefully lead to a shorter disease course with fewer complications, a faster recovery, lower health care costs and improved quality of life.
Onderzoeksopzet
Follow-up will be one year and includes clinical follow-up and patient questionnaires, after one year primary and secondary outcomes will be measured.
Onderzoeksproduct en/of interventie
None
Publiek
Hester Timmerhuis
+3188 3207051
h.timmerhuis@antoniusziekenhuis.nl
Wetenschappelijk
Hester Timmerhuis
+3188 3207051
h.timmerhuis@antoniusziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients over 18 years of age
- Patients with necrotizing pancreatitis as defined by the revised Atlanta Classification
- >3/4 weeks after onset of acute pancreatitis
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Diagnosis of (or acute flare up of) chronic pancreatitis according to the M-ANNHEIM criteria
- Diagnosis of pancreatic carcinoma previous to the index admission or on the CT on which (peri)pancreatic necrosis is diagnosed
- Traumatic aetiology of pancreatitis
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL8123 |
Ander register | MEC-U, St. Antoniusziekenhuis Nieuwegein : W019.086 |