The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial
Canada45 participantsStarted 2021-06-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients age 18 and over at time of diagnosis
* Resectable presumed liver, pancreas, or bile duct malignancy (i.e., liver metastases, HCC, cholangiocarcinoma, pancreatic or periampullary adenocarcinoma, NETs)as determined by surgeon in clinic
* Anticipated hospital stay at least three days post-surgery
* Ability to tolerate oral intake and comply with protocol requirements
Exclusion Criteria:
* Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A). Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (\<7.5 mg daily)
* Subjects with resting hypotension (BP \<90/50 at rest)
* History of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis
* Serious, active, intercurrent chronic or acute illness, or other active illness considered by the investigator as an unwarranted high risk for an investigational product
* Active infection of any site and/or active herpes requiring ongoing treatment
* Known pregnancy or nursing mothers
* Subjects with an allergy to the nutritional supplement or comparator including milk, fish and/or shellfish allergies
* Subjects with religious or other objections to consuming fish or shellfish
* Subjects with severe asthma defined as asthma not controlled with inhale…
What they're measuring
1
Natural killer (NK) cell killing
Timeframe: Post-operative day 1 (Day 1) as compared to baseline (pre-operative)