ERAS Versus ERAS Plus Artificial Nutrition in Open Pancreatoduodenectomy (RASTA)
Pancreas Disease
About this trial
This is an interventional treatment trial for Pancreas Disease focused on measuring ERAS, artificial nutrition, pancreatoduodenectomy
Eligibility Criteria
Inclusion Criteria:
- Adult patients (age ≥ 18 and < 90 years of age) candidate to elective pancreatoduodenectomy for any periampullary or pancreatic cancer
Exclusion Criteria:
- American Society of Anaesthesiologists (ASA) physical status classification > 3
- Weight loss > 15% with respect to usual weight in the last 6 months
- Child-Pugh > A
- Not signed consent
- Palliative surgery
- Placement of a naso-enteric or jejunostomy feeding tube
Sites / Locations
- University of Milano-BicoccaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ERAS plus artificial nutrition
Enhanced recovery protocol
Patients randomised in the treatment arm will be treated with a full ERAS protocol that establishes oral food "at will" plus parenteral nutrition (PN) from postoperative day 1. A 3-bag compartment peripheral parenteral solution (mOsm < 800) containing carbohydrate, lipids and proteins will be infused to deliver 20/25 total Kcal/kg for a total of 5 days after the operation. In case of the occurrence of any complication impairing the full or partial recovery of oral food, the treatment will be continued until clinically indicated
Patients randomised in the control arm will be treated with a full ERAS protocol that establishes oral food "at will". In case of the occurrence of any complication impairing the full recovery of oral food within postoperative day 7, patients will receive parenteral nutrition as in the treated arm until clinically indicated