Enteral vs. Oral Nutrition After Pancreatoduodenectomy

NCT ID: NCT05042882

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-12
• Study Completion Date: 2025-01-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Early enteral nutrition

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).

Group Type: EXPERIMENTAL

Early enteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

Enteral nutrition via nasojejunal tube

Oral nutrition

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early enteral nutrition

Enteral nutrition via nasojejunal tube

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Gaëtan-Romain Joliat

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaëtan-Romain Joliat, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Markus Schäfer, MD

Role: STUDY_DIRECTOR

University of Lausanne Hospitals

Nicolas Demartines, MD

Role: STUDY_CHAIR

University of Lausanne Hospitals

Locations

Hôpital Cochin-Port Royal, AP-HP

Paris, , France

Lausanne University Hospital (CHUV)

Lausanne, Canton of Vaud, Switzerland

Regional Hospital of Lugano

Lugano, Canton Ticino, Switzerland

Countries

France; Switzerland

References

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.

Reference Type: DERIVED

PMID: 35865476 (View on PubMed)

Other Identifiers

2021-00724

Identifier Type: -

Identifier Source: org_study_id