NCT00558155

Brief Summary

The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205 subjects were randomly assigned into four study groups, standard and immunostimulating, enteral and parenteral. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P50-P75 for phase_4 gastric-cancer

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_4 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2001

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

November 9, 2007

Last Update Submit

November 13, 2007

Conditions

Gastric CancerPancreatic Cancer

Keywords

immunonutritionenteral nutritionparenteral nutritionsurgery

Outcome Measures

Primary Outcomes (1)

  • During the postoperative period, all patients were observed for both surgical and non-surgical complications

    52 months

Secondary Outcomes (1)

  • The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

    52 months

Study Arms (4)

SEN

EXPERIMENTAL

standard enteral nutrition

Drug: peptisorb

IMEN

EXPERIMENTAL

immunostimulating enteral nutrition

Drug: Stresson

SPN

EXPERIMENTAL

standard parenteral nutrition

Drug: Parenteral nutrition

IMPN

EXPERIMENTAL

immunostimulating parenteral nutrition

Drug: Omegaven, Dipeptiven

Interventions

peptisorbDRUG

standard isocaloric eteral diet (1 ml = 1 kcal)

SEN
StressonDRUG

Oligopeptic, enteral diet (1 ml=1.25 kcal)

IMEN
Parenteral nutritionDRUG

Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel

SPN
Omegaven, DipeptivenDRUG

Immunostimulating components: Omegaven (omega-3-fatty acids) and Dipeptiven (Glutamine Arginine) Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel

IMPN

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • resectable gastric or pancreatic cancer
  • age between 18 and 80 years,
  • Karnofsky performance status score of 80 or more,
  • adequate organ function

You may not qualify if:

  • unresectable gastric or pancreatic cancer
  • patients requiring preoperative nutritional support,
  • disseminated tumors,
  • serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5),
  • renal or liver failure were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Department of General Surgery

Krakow, 30-798, Poland

Location

Related Publications (2)

  • Klek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. Perioperative nutrition in malnourished surgical cancer patients - a prospective, randomized, controlled clinical trial. Clin Nutr. 2011 Dec;30(6):708-13. doi: 10.1016/j.clnu.2011.07.007. Epub 2011 Aug 5.

    PMID: 21820770DERIVED

  • Klek S, Kulig J, Sierzega M, Szybinski P, Szczepanek K, Kubisz A, Kowalczyk T, Gach T, Pach R, Szczepanik AM. The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial. Ann Surg. 2008 Aug;248(2):212-20. doi: 10.1097/SLA.0b013e318180a3c1.

    PMID: 18650630DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsPancreatic NeoplasmsHyperphagia

Interventions

Parenteral Nutritionfish oil triglyceridesalanylglutamine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Stanislaw Klek, PhD, MD

    Jagiellonian University 1 Dept Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2007

First Posted

November 14, 2007

Study Start

June 1, 2001

Study Completion

December 1, 2005

Last Updated

November 14, 2007

Record last verified: 2007-11

Locations

PL(1)