Exocrine Pancreatic Insufficiency After Acute Pancreatitis and Pancreatic Enzyme Replacement Therapy
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Acute pancreatitis represents an acute inflammatory process of the pancreas, which undergoes
local and systemic complications, associated with non-negligible morbidity and mortality, and
significant economic and quality of life impact. Even after the recovery phase, the
development and persistence of sequelae from the inflammatory/necrotic process, including
exocrine and endocrine pancreatic insufficiencies, are frequent. Although well documented as
consequence of other pancreatic conditions, exocrine pancreatic insufficiency (EPI) after
acute pancreatitis is poorly studied and probably underdiagnosed. The prevalence, diagnosis,
independent risk factors and therapeutic approaches for EPI after acute pancreatitis need
further investigation. Recent evidence suggests the involvement of the pancreas-intestinal
axis and immunological dysfunction in several pancreatic pathologies, although their role in
the development of EPI after acute pancreatitis is still scarce. Pancreatic enzyme
replacement therapy (PERT) is the only treatment currently available in EPI, but the timing
for start and duration of this therapy in acute pancreatitis remain to be established. This
study have the following objectives: to determine the prevalence, clinical, analytical and
nutritional biomarkers and duration of EPI after acute pancreatitis, as well as changes in
gut microbiota and immunologic response, and quality of life in EPI and response to PERT
after acute pancreatitis; and to determine the prevalence and biomarkers associated with
endocrine pancreatic insufficiency following acute pancreatitis and the presence of gut
dysbiosis and immunologic changes in acute pancreatitis according to its severity.
Phase:
N/A
Details
Lead Sponsor:
Centro Hospitalar e Universitário de Coimbra, E.P.E.