NCT01642875

Brief Summary

Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative complications often preclude or delay adequate oral nutrition and nutritional support may be required. However, the role of perioperative nutritional supplementation in well-nourished patients remains controversial. The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy. 96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and oral intake will be advanced as tolerated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P25-P50 for phase_4 pancreatic-cancer

Timeline
Completed

Started Nov 2016

Typical duration for phase_4 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
4.3 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

3.1 years

First QC Date

July 9, 2012

Last Update Submit

November 22, 2016

Conditions

Pancreatic CancerCancer of the DuodenumCholangiocarcinomaChronic Pancreatitis

Keywords

Periampullary tumorChronic pancreatitisPancreatoduodenectomyOral NutritionEnteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • Frequency of delayed gastric emptying

    30 days after operation

Secondary Outcomes (6)

  • Overall morbidity rate

    60 days after operation

  • Perioperative mortality rate

    60 days after operation

  • Postoperative hospital stay length

    60 days after operation

  • Time to full oral nutrition

    60 days after operation

  • Time to resolution of paralytic ileus

    7 days after operation

  • +1 more secondary outcomes

Study Arms (2)

EN

EXPERIMENTAL

early enteral nutrition with standard enteral formulas administered through a nasojejunal tube

Other: Enteral nutrition

PerOs

ACTIVE COMPARATOR

early oral nutrition with hospital diets and oral formulas

Other: Oral nutrition

Interventions

Enteral nutritionOTHER

Standard enteral diet is administered through a nasojejunal tube. Enteral nutrition is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.

Also known as: standard enteral formula
EN
Oral nutritionOTHER

Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated

Also known as: oral diet
PerOs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary periampullary tumor
  • R0, R1 resection
  • Chronic pancreatitis requiring pancreatoduodenectomy

You may not qualify if:

  • Metastatic tumor
  • Locally unresectable tumor
  • Previous gastric resection
  • ASA IV-V
  • Age under 18 years
  • Preoperative complete parenteral or enteral feeding
  • Immunosuppressive therapy before operation
  • Severe malnutrition
  • Lack of the patient's consent for the trial participation, feeding tube insertion or epidural analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sp Csk Wum

Warsaw, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsDuodenal NeoplasmsCholangiocarcinomaPancreatitis, Chronic

Interventions

Enteral NutritionNutritional StatusDiet

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesDuodenal DiseasesIntestinal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition TherapyNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Maciej Słodkowski, MD

    Medical University of Warsaw

    STUDY DIRECTOR

  • Marek Wronski, MD

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maciej Słodkowski, MD

CONTACT

0048 22 599 2251maciejslodkowski@wp.pl

Marek Wroński, MD

CONTACT

0048 22 599 2482mwronski@vp.pl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 17, 2012

Study Start

November 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

PL(1)