Clinical trial NCT05042882: Enteral vs. Oral Nutrition After Pancreatoduodenectomy
Official title: Early Enteral vs. Oral Nutrition After Whipple Procedure: a Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreaticoduodenectomy
Malnutrition
Postoperative Complications
Keywords: Enteral nutrition
Oral nutrition
Pancreatoduodenectomy
Whipple operation
Pancreas surgery
Morbidity
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Comprehensive Complication Index
timeFrame: Postoperative day 90
Secondary outcomes:
measure: Severe postoperative complications
timeFrame: Postoperative day 90
measure: Specific complications after pancreatoduodenectomy
timeFrame: Postoperative day 90
measure: Length of stay
timeFrame: Up to 90 days
measure: Readmission
timeFrame: Postoperative day 90
measure: Patients' quality of life
timeFrame: Preoperatively and at 30 and 90 days after the operation
measure: Metabolic response to enteral nutrition
timeFrame: Preoperatively and twice weekly during the first postoperative week
measure: Body composition
timeFrame: Preoperatively and on the day when patients leave the hospital after the operation
measure: Muscular measure
timeFrame: Preoperatively and on the day when patients leave the hospital after the operation
measure: Resting energy expenditure
timeFrame: On postoperative day 5
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin-Port Royal, AP-HP
city: Lugano
country: Switzerland
facility: Regional Hospital of Lugano
state: Ticino
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital (CHUV)
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Gaëtan-Romain Joliat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lausanne Hospitals
name: Markus Schäfer, MD
role: STUDY_DIRECTOR
affiliation: University of Lausanne Hospitals
name: Nicolas Demartines, MD
role: STUDY_CHAIR
References:
citation: 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.