No registrations found.
ID
Source
Brief title
Health condition
Acute pancreatitis, acute necrotizing pancreatitis, disconnected pancreatic duct syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of disrupted or disconnected pancreatic duct
Secondary outcome
Clinical outcome of a disrupted or disconnected pancreatic duct (location and degree of parenchymal necrosis,location and degree of disruption of the pancreatic duct, microbiological cultures, type and number of interventions, drain in situ time, peri-procedural complications, overall complicaties, organ failure, mortality, lenght of hospital stay, lenght op ICU stay, number of readmissions, wuality of life).
Background summary
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.
Study objective
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.
Study design
Follow-up will be one year and includes clinical follow-up and patient questionnaires, after one year primary and secondary outcomes will be measured.
Intervention
None
Hester Timmerhuis
+3188 3207051
h.timmerhuis@antoniusziekenhuis.nl
Hester Timmerhuis
+3188 3207051
h.timmerhuis@antoniusziekenhuis.nl
Inclusion criteria
- 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
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8123 |
| Other | MEC-U, St. Antoniusziekenhuis Nieuwegein : W019.086 |