Clinical associations with pancreatic exocrine insufficiency
Research type
Research Study
Full title
Clinical associations with pancreatic exocrine insufficiency
IRAS ID
277277
Contact name
Ben Shandro
Contact email
Sponsor organisation
St George's University of London
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
Pancreatic exocrine insufficiency occurs when the insufficient secretion or function of pancreatic enzymes leads to maldigestion, and is associated with significant morbidity. It has been established that the most common causes of pancreatic exocrine insufficiency are chronic pancreatitis and pancreatic cancer. However, there is some evidence linking it with refractory coeliac disease, cirrhosis, diabetes mellitus, alcohol excess, congestive cardiac failure, HIV, chronic kidney disease, hyperparathyroidism, smoking, gastrointestinal surgery, and increasing age. Most of these purported associations are based on small observational studies or case series.
We will conduct a retrospective review of the electronic patient record of patients who have undergone testing for pancreatic exocrine insufficiency at a London teaching hospital, using the faecal elastase assay, to explore if the above associations hold true in our patient population, thereby adding to the existing knowledge about this condition. In addition, this will be the first study in humans to explore the associations betweens proton pump inhibitor therapy, previous cholecystectomy, and bile acid malabsorption with pancreatic exocrine insufficiency. All of these conditions could conceivably be associated with pancreatic exocrine insufficiency, and have not been studied before.
The study population is all patients aged over 18 attending gastroenterology services at a single London hospital who have undergone faecal elastase testing for pancreatic exocrine insufficiency over a 6 year period. The study will involve analysis of data that has been previously collected during routine clinical care, and will have no impact on any individual's clinical care. Statistical analysis will be by multivariable logistic regression modelling. We would plan to publish results in a peer-reviewed journal.
REC name
London - Fulham Research Ethics Committee
REC reference
20/LO/0433
Date of REC Opinion
1 Apr 2020
REC opinion
Favourable Opinion