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Enteral vs. Oral Nutrition After Pancreatoduodenectomy (NUTRIWHI)

Primary Purpose

Pancreaticoduodenectomy, Malnutrition, Postoperative Complications

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Early enteral nutrition
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pancreaticoduodenectomy focused on measuring Enteral nutrition, Oral nutrition, Pancreatoduodenectomy, Whipple operation, Pancreas surgery, Morbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atrium Health Carolinas Medical Center
  • Regional Hospital of Lugano
  • Lausanne University Hospital (CHUV)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early enteral nutrition

Oral nutrition

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Comprehensive Complication Index
Index measuring all complications for a patient

Secondary Outcome Measures

Severe postoperative complications
Dindo-Clavien >II
Specific complications after pancreatoduodenectomy
SSI, DGE, POPF, PPH, biliary fistula, gastrojejunal anastomosis fistula, pancreatitis
Length of stay
From operation day to hospital discharge
Readmission
Hospital readmission due to surgical complications
Patients' quality of life
EORTC questionnaires
Metabolic response to enteral nutrition
Laboratory results
Body composition
Bioelectrical impedance analysis
Muscular measure
Handgrip strength measure
Resting energy expenditure
Indirect calorimetry

Full Information

First Posted
August 30, 2021
Last Updated
May 21, 2023
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT05042882
Brief Title
Enteral vs. Oral Nutrition After Pancreatoduodenectomy
Acronym
NUTRIWHI
Official Title
Early Enteral vs. Oral Nutrition After Whipple Procedure: a Multicentric Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreaticoduodenectomy, Malnutrition, Postoperative Complications
Keywords
Enteral nutrition, Oral nutrition, Pancreatoduodenectomy, Whipple operation, Pancreas surgery, Morbidity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early enteral nutrition
Arm Type
Experimental
Arm Description
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).
Arm Title
Oral nutrition
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Early enteral nutrition
Intervention Description
Enteral nutrition via nasojejunal tube
Primary Outcome Measure Information:
Title
Comprehensive Complication Index
Description
Index measuring all complications for a patient
Time Frame
Postoperative day 90
Secondary Outcome Measure Information:
Title
Severe postoperative complications
Description
Dindo-Clavien >II
Time Frame
Postoperative day 90
Title
Specific complications after pancreatoduodenectomy
Description
SSI, DGE, POPF, PPH, biliary fistula, gastrojejunal anastomosis fistula, pancreatitis
Time Frame
Postoperative day 90
Title
Length of stay
Description
From operation day to hospital discharge
Time Frame
Up to 90 days
Title
Readmission
Description
Hospital readmission due to surgical complications
Time Frame
Postoperative day 90
Title
Patients' quality of life
Description
EORTC questionnaires
Time Frame
Preoperatively and at 30 and 90 days after the operation
Title
Metabolic response to enteral nutrition
Description
Laboratory results
Time Frame
Preoperatively and twice weekly during the first postoperative week
Title
Body composition
Description
Bioelectrical impedance analysis
Time Frame
Preoperatively and on the day when patients leave the hospital after the operation
Title
Muscular measure
Description
Handgrip strength measure
Time Frame
Preoperatively and on the day when patients leave the hospital after the operation
Title
Resting energy expenditure
Description
Indirect calorimetry
Time Frame
On postoperative day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaëtan-Romain Joliat, MD
Phone
+41795564293
Email
gaetan.joliat@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaëtan-Romain Joliat, MD
Organizational Affiliation
Lausanne University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Schäfer, MD
Organizational Affiliation
Lausanne University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nicolas Demartines, MD
Organizational Affiliation
Lausanne University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Atrium Health Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dionisios Vrochides
First Name & Middle Initial & Last Name & Degree
Dionisios Vrochides
Facility Name
Regional Hospital of Lugano
City
Lugano
State/Province
Ticino
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Cristaudi, MD
First Name & Middle Initial & Last Name & Degree
Alessandra Cristaudi, MD
First Name & Middle Initial & Last Name & Degree
Pietro Majno-Hurst
Facility Name
Lausanne University Hospital (CHUV)
City
Lausanne
State/Province
Vaud
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaëtan-Romain Joliat, MD
First Name & Middle Initial & Last Name & Degree
Gaëtan-Romain Joliat, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35865476
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.
Results Reference
derived

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Enteral vs. Oral Nutrition After Pancreatoduodenectomy

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