Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by University Hospital, Geneva. Recruitment status was Recruiting

First Received on November 19, 2007. Last Updated on January 14, 2010 History of Changes

Sponsor:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00560846

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:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Dextrose

U.S. FDA Resources

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 ]

Estimated Enrollment:	95
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	August 2010 (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

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

Contacts

Contact: Dan E Azagury, MD	+41223727704	dan.azagury@hcuge.ch
Contact: Olivier Huber, PD	+41223727704	olivier.huber@hcuge.ch

Locations

Switzerland
Hôpitaux Universitaires Genève	Recruiting
Geneva, Switzerland, 1204

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Principal Investigator:

Dan E Azagury, MD

Geneva University Hospital

More Information

No publications provided

Responsible Party:	Principal investigator, 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:	January 14, 2010
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
Esophageal Diseases
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Diseases
Digestive System Diseases

Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Stomach Diseases

ClinicalTrials.gov processed this record on February 13, 2012