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. - Preoperative pancreatic enzyme supplementation in Whipple’s procedure

niversity Hospitals Southampton NHS Trust0 sites128 target enrollmentJune 30, 2018

Overview

No summary available.

Registry

who.int

Start Date

June 30, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospitals Southampton NHS Trust

•All patients with operable pancreatic head or periampullary tumours will be approached for this study.
•Patients are considered operable after discussion in the Hepatobiliary Pancreatic multidisciplinary meeting. Patients are considered operable in the absence of any distant metastasis and/or invasion of the superior meseteric vein and artery.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 0
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 0

•Exclusion criteria
•1\-Cholangitis / infection requiring hospitalisation.
•2\-Previous chemotherapy for this malignancy.
•3\-Severe gastric outlet obstruction (stenosis of the duodenum due to tumour growth) defined as vomiting, nausea and/or oral intake less than one /day.
•4\-Patients with known malnutrition not related to the pancreatic cancer (anorexia, mal absorption).
•5\-Vulnerable patients (Patients who are unable to give consent).
•6\-Less than 2 weeks between purported start of nutritional supplementation with or without pancreatic enzyme supplements and the date of pancreatic resection.
•7\-Hypersensitivity to Pancreatin of porcine origin or to any of the excipients.