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

Pancreas Disease

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

parenteral feeding

University of Milano-Bicocca

ERAS Versus ERAS Plus Artificial Nutrition in Open Pancreatoduodenectomy

The primary endpoint of the trial is the complication burden as measured by the Comprehensive Complication Index (CCI)

Luca Vittorio Gianotti

Professor of surgery

University of Milano Bicocca

RASTA will be a randomised controlled multicentre single-blind, parallel arm, superiority, phase-3 trial

Patients will be randomly allocated to ERAS or ERAS plus PN at 8:00 PM of the first postoperative days. Randomisation will be performed by a computed-generated permuted-block sequence. A specific code will be generated for each centre to achieve equivalent grouping. The allocation ratio will be 1:1 with a block size of 4. Randomization will be competitive among centers.
Surgeons will not be blinded to treatment arm. Masking to allocation will be impossible to achieve for the nature of the study. Patients will be evaluated for outcomes by assessors not directly involved in patient care and masked to patient allocation

MVR: Multivisceral resection was considered when the exeresis of an organ other than the pancreatic body-tail and / or spleen was performed.

Pancreatic Neoplasms

Surgical Procedure, Unspecified

Multivisceral resection was considered when the exeresis of an organ other than the pancreatic body-tail and / or spleen was performed.

Universidad de Extremadura- Facultad de Medicina

Multivisceral Resection in Distal Pancreatectomy

Distal Pancreatectomy With Multivisceral Resection: A Multicentric Study

Any complication in the postoperative period

If the patient dies in the postoperative period

The study data will be available upon request to the principal investigator via e-mail.

Gerardo Blanco-Fernández

Chief of department

Universidad de Extremadura

ERAS-protocol as described in low risk patients after pancreaticoduodenectomy or total pancreatectomy

Standard recovery protocol after pancreaticoduodenectomy or total pancreatectomy

Pancreatic Cancer

Surgery--Complications

Pancreatic Fistula

Delayed Gastric Emptying

Pancreatic Hemorrhage

First appointment:
- Enlightenment on the benefits and objectives of the ERAS protocol
Call to the patient day before the surgery:
Discussing the course, benefits and goals of care in ERAS 4 dl PreOp drink before bedtime
Operation day:
Fluid intake allowed 2 hours before surgery 2 dl PreOP drink 2 h before cutting

ERAS protocol preoperative actions

Intraoperative:
Drains in the peripancreatic or perihepatic regions are not set unless the surgeon sees this particular reason The nasogastric tube is removed at the end of the surgery

ERAS protocol intraoperative actions

Postoperatively:
Mobilization with nurses assisted Drinks allowed after 4h surgery
POP 1:
Drinking and normal food Removal of urinary catheter Intravenous liquids only if needed Mobilization Pain management by epidural cannula Discussion of the ERAS protocol Pancreatin capsules per os before eating
Postoperative day 2:
- Mobilization: As much as possible, autonomous movement
Postoperative day 3:
Ending epidural infusion cannula removal Mobilization as independently as possible
Pain relief: oxycodone/naloxone p.o. to keep mobilization possible:
Postoperative day 4:
Support and encouragement continues Pain management at a level that allows mobility

ERAS protocol postoperative actions

Tampere University Hospital Deparment of Gastroenterologic Surgery

ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy

Enhanced Recovery Versus Standard Recovery After Low-risk Pancreatoduodenectomy Identified With Acinar Cell Count or Total Pancreatectomy: a Randomized Controlled Trial

Time in days since the entry to hospital on the surgery day to the discharge day to follow up care or home

Time in days since the entry to hospital on the surgery day to the discharge day from the follow up care

pancreatic fistula/carbohydrate

ERAS Versus ERAS Plus Artificial Nutrition in Open Pancreatoduodenectomy

Multivisceral Resection in Distal Pancreatectomy

ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy

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