The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial

Official Title

The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial: A Randomized Phase II Trial of the Impact of Perioperative Immunomodulation on Immune Function Following Resection for HepatoPancreaticoBiliary Malignancy

Summary:

This is a randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy.

Trial Description

Primary Outcome:

• Natural killer (NK) cell killing

Secondary Outcome:

• Secondary immune function outcomes: Immune cell subsets
• Secondary immune function outcomes: NK cell activating and inhibitory receptors
• Secondary immune function outcomes: amino acid levels
• Incidence of pancreatic fistula
• Postoperative wound complication and surgical site infection
• Length of stay
• 90-day postoperative complications (Clavien-Dindo 3-5)
• 90-day postoperative mortality
• Incidence of liver insufficiency

This is a 1:1:1 randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy. Two variations of immunosupplementation will be compared to control nutritional supplement containing whey protein with an additional teaspoon (tsp) of placebo oil. These variations will be 1) a powdered formula containing whey protein and arginine (Active A) with an additional tsp of lipid bolus containing omega-3 fatty acids, and 2) a powdered formula containing whey protein and arginine (Active A) with an additional tsp of placebo oil which does not contain omega-3 fatty acids. The control nutritional supplement will be a powdered formula containing whey protein with an additional tsp of placebo oil.

View this trial on ClinicalTrials.gov