Enteral vs. Oral Nutrition After Pancreatoduodenectomy

NCT05042882 | Completed

• 1 other identifier: 2021-00724
• Study Type: interventional
• Target: 144
• Locations: 2 countries
• Sites: 3

Brief Summary

Patients suffering from pancreas cancer as well as patients with chronic pancreatitis or requiring pancreas surgery often are in a compromised nutritional status. Nutritional support should therefore be started early during the postoperative course to prevent further malnutrition, as it is an important risk factor to develop complications. Recently, several studies have shown that early enteral nutrition (EEN) could shorten length of stay, reduce postoperative infections and mortality, and decrease costs when compared with total parenteral nutrition (TPN) in gastrointestinal cancer surgery. After pancreatoduodenectomy (PD), EEN has been shown to reduce early and late complications, infections, and readmission rates. It is nevertheless currently not clear if EEN improves the short-term outcomes after PD compared to oral nutrition. The primary objective of the study is to assess the impact of EEN on postoperative morbidity after PD, according to the Comprehensive Complication Index. Secondary objectives are to assess the impact of EEN on major postoperative complications, according to Clavien classification, specific complications, length of stay, readmission rates, quality of life, metabolic stress and nutritional response after PD.

Conditions

Pancreaticoduodenectomy; Malnutrition; Postoperative Complications

Keywords

Enteral nutrition; Oral nutrition; Pancreatoduodenectomy; Whipple operation; Pancreas surgery; Morbidity

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication Index

  Index measuring all complications for a patient

  Postoperative day 90

Secondary Outcomes (9)

• Severe postoperative complications

  Postoperative day 90

• Specific complications after pancreatoduodenectomy

  Postoperative day 90

• Length of stay

  Up to 90 days

• Readmission

  Postoperative day 90

• Patients' quality of life

  Preoperatively and at 30 and 90 days after the operation

Study Arms (2)

Early enteral nutrition

EXPERIMENTAL

Intervention group: enteral nutrition from the first postoperative night until 50% of caloric requirements are covered by oral nutrition. Enteral nutrition will start at a flow of 250 ml/12h. If tolerated, enteral nutrition will be increased to 500 ml/12h on postoperative day 1, 750 ml/12h on postoperative day 2, and 1000 ml/12h on postoperative day 3. A hypercaloric enteral nutrition will be used (Isosource Energy Fibre or similar).

Dietary Supplement: Early enteral nutrition

Oral nutrition

NO INTERVENTION

Control group: patients will receive standardized oral nutrition. The night after the operation, patients will be allowed to have free drinks. On postoperative day 1, they will receive bouillons, creams, yogurts, and drinks \>2 l. On postoperative day 2, they will receive a light diet. On postoperative day 3, they will receive half portion of normal diet and on postoperative day 4 normal diet.

Interventions

Early enteral nutrition DIETARY_SUPPLEMENT

Enteral nutrition via nasojejunal tube

Early enteral nutrition

Eligibility Criteria

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

You may qualify if:

• Patient scheduled for elective open pancreatoduodenectomy.
• Patient ≥18 years old.
• Patient at nutritional risk, i.e., with Nutrition Risk Screening (NRS) ≥3.
• Signed informed consent.

You may not qualify if:

• Patient not able to give informed consent as documented by signature of consent form (e.g., vulnerable patients).
• Enteral feeding already initiated preoperatively.
• Language barrier.
• Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders (i.e., eating disorders and bipolar disorders), or dementia.

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (3)

Hôpital Cochin-Port Royal, AP-HP

Paris, France

Location

Lausanne University Hospital (CHUV)

Lausanne, Canton of Vaud, Switzerland

Location

Regional Hospital of Lugano

Lugano, Canton Ticino, Switzerland

Location

Related Publications (1)

• Joliat GR, Martin D, Labgaa I, Melloul E, Uldry E, Halkic N, Fotsing G, Cristaudi A, Majno-Hurst P, Vrochides D, Demartines N, Schafer M. Early enteral vs. oral nutrition after Whipple procedure: Study protocol for a multicentric randomized controlled trial (NUTRIWHI trial). Front Oncol. 2022 Jun 28;12:855784. doi: 10.3389/fonc.2022.855784. eCollection 2022.

  PMID: 35865476 DERIVED

MeSH Terms

Conditions

Malnutrition; Postoperative Complications

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaëtan-Romain Joliat, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

• Markus Schäfer, MD

  University of Lausanne Hospitals

  STUDY DIRECTOR

• Nicolas Demartines, MD

  University of Lausanne Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 13, 2021
• Study Start: December 12, 2021
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

CH (2); FR (1)