Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery

This study has been terminated.
(Insufficient recruitment over time.)
Sponsor:
Information provided by (Responsible Party):
Dan Azagury, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00560846
First received: November 19, 2007
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

The aim of this study is to demonstrate the influence of peri-operative nutrition on the post-operative complications, preservation of lean body mass and length of stay after gastrectomy or oesophagectomy.


Condition Intervention
Stomach Neoplasms
Esophageal Neoplasms
Dietary Supplement: Impact
Dietary Supplement: Glucose load

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Rate of post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: November 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutrition
Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition
Dietary Supplement: Impact
Preoperative 5 day oral Impact and early post-operative enteral Impact
Dietary Supplement: Glucose load
Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
Other Name: PreOp Nutricia
No Intervention: Control
No immunonutrition, no glucose load, no early enteral immunonutrition

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgery for Upper GI cancer
  • Age over 18
  • Informed consent

Exclusion Criteria:

  • Major swallowing disorders
  • Dementia or other psychological state precluding compliance and understanding of research protocol
  • Pre-existing enteral or parenteral nutrition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560846

Locations
Switzerland
Hôpitaux Universitaires Genève
Geneva, Switzerland, 1204
Sponsors and Collaborators
Dan Azagury
Investigators
Principal Investigator: Dan E Azagury, MD Geneva University Hospital
  More Information

No publications provided

Responsible Party: Dan Azagury, Medecin adjoint du chef de service, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00560846     History of Changes
Other Study ID Numbers: CER: 07-123
Study First Received: November 19, 2007
Last Updated: September 4, 2013
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:
Gastric cancer
Esophageal cancer
Surgical complications
Immunonutrition

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on September 22, 2014