Preoperative pancreatic enzyme supplementation in Whipple’s procedure
Research type
Research Study
Full title
Change in nutritional state and postoperative outcome following preoperative introduction of nutritional supplements and pancreatic enzymes in patients undergoing Whipple’s procedure for pancreatic cancer (PREPARE): a randomised controlled trial.
IRAS ID
241433
Contact name
Sharon Davies-Dear
Contact email
Sponsor organisation
University Hospitals Southampton NHS Trust
Eudract number
2018-000242-19
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Do preoperative nutritional supplements and pancreatic enzymes have an impact on postoperative outcome in patients undergoing a Whipples procedure for pancreatic head tumours?
Several studies have shown that preoperative malnutrition affects the post-operative outcome of cancer patients. Patients with pancreatic head tumours are particularly prone to malnutrition compared to patients with other type of cancers, as weight loss and malabsorption (inability to absorb nutrients) are present in 80-90% of patients at the time of diagnosis. The main reason for malabsorption in patients with pancreatic head tumours is an insufficient secretion of pancreatic enzyme through obstruction of the pancreatic duct by the tumour and loss of normal pancreatic tissue. The common end result is weight loss, vague abdominal discomfort, pain, abdominal distension, diarrhoea and foul-smelling flatus. However, nutritional assessments and nutritional supplements prior to surgery do not represent the standard clinical practice in most pancreatic surgical units. To date no data are available regarding preoperative supplementation with pancreatic enzymes. The aim of this randomised, placebo controlled, multi-centre trial is to investigate the effect of preoperative pancreatic enzymes and nutritional supplements on nutritional status and postoperative outcome in patients with pancreatic head tumours.
Patients will be randomised 2-6 weeks prior to their surgery into one of the two study arms: the first arm will receive nutritional supplements and pancreatic enzymes, the other arm will receive nutritional supplements and a placebo. Nutritional status will be assessed by bio-electrical impedance, Subjective Global Assessment, handgrip strenght and blood tests. Quality of life will be measured by two questionnaires. The follow-up duration will be up to 6 weeks postoperative.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0101
Date of REC Opinion
6 Apr 2018
REC opinion
Further Information Favourable Opinion