ERAS Versus ERAS Plus Artificial Nutrition in Open Pancreatoduodenectomy

NCT04438447 | Unknown DMC

• 1 other identifier: RASTA-2020
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

there is a need of a randomised clinical trial specifically design to explore whether given a full nutritional requirement by parenteral feeding in the first 5 days after surgery coupled with oral food "at will" compared to only oral food "at will", within an established ERAS program, could achieve a reduction of the morbidity burden

Conditions

Pancreas Disease

Keywords

ERAS; artificial nutrition; pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication Index (CCI)

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

  within 30 days after hospital discharge

Secondary Outcomes (1)

• Clavien-Dindo severity score

  30 days after discharge

Study Arms (2)

ERAS plus artificial nutrition

EXPERIMENTAL

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

Dietary Supplement: parenteral feeding

Enhanced recovery protocol

ACTIVE COMPARATOR

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

Dietary Supplement: parenteral feeding

Interventions

parenteral feeding DIETARY_SUPPLEMENT

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

ERAS plus artificial nutrition; Enhanced recovery protocol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age ≥ 18 and \< 90 years of age) candidate to elective pancreatoduodenectomy for any periampullary or pancreatic cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

University of Milano-Bicocca

Monza, 20900, Italy

RECRUITING

Related Publications (3)

• Gianotti L, Besselink MG, Sandini M, Hackert T, Conlon K, Gerritsen A, Griffin O, Fingerhut A, Probst P, Abu Hilal M, Marchegiani G, Nappo G, Zerbi A, Amodio A, Perinel J, Adham M, Raimondo M, Asbun HJ, Sato A, Takaori K, Shrikhande SV, Del Chiaro M, Bockhorn M, Izbicki JR, Dervenis C, Charnley RM, Martignoni ME, Friess H, de Pretis N, Radenkovic D, Montorsi M, Sarr MG, Vollmer CM, Frulloni L, Buchler MW, Bassi C. Nutritional support and therapy in pancreatic surgery: A position paper of the International Study Group on Pancreatic Surgery (ISGPS). Surgery. 2018 Nov;164(5):1035-1048. doi: 10.1016/j.surg.2018.05.040. Epub 2018 Jul 17.

  PMID: 30029989 BACKGROUND

• Gianotti L, Paiella S, Capretti G, Pecorelli N, Frigerio I, Sandini M, Fogliati A, Vico E, Braga M, Cotsoglou C, Pedalino A, Malleo G, Ricchitelli S, Caspani S, Guarneri G, Vallorani A, Giardino A, Pasqualoni E, Salvia R, Zerbi A, Falconi M, Butturini G, Bernasconi DP. Supplemental parenteral nutrition within an enhanced recovery program for open pancreatoduodenectomy for cancer: a pragmatic, multicenter, randomized controlled trial. EClinicalMedicine. 2025 Aug 21;87:103455. doi: 10.1016/j.eclinm.2025.103455. eCollection 2025 Sep.

  PMID: 40896466 DERIVED

• Gianotti L, Paiella S, Frigerio I, Pecorelli N, Capretti G, Sandini M, Bernasconi DP. ERAS with or without supplemental artificial nutrition in open pancreatoduodenectomy for cancer. A multicenter, randomized, open labeled trial (RASTA study protocol). Front Nutr. 2023 Mar 27;10:1113723. doi: 10.3389/fnut.2023.1113723. eCollection 2023.

  PMID: 37051129 DERIVED

MeSH Terms

Conditions

Pancreatic Diseases

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Maria G Valsecchi, PhD

  University of Milano Bicocca

  STUDY DIRECTOR

Central Study Contacts

Luca Gianotti, MD

CONTACT

++39-039233; luca.gianotti@unimib.it

Silvia Mori, PhD

CONTACT

++39-02 6448; bicro@unimib.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of surgery

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

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: April 14, 2022
• Primary Completion: September 10, 2022
• Study Completion: December 31, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)