Perioperative Nutrition in Upper Gastrointestinal (GI) Ca... | NCT00560846

Studies
Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery

NCT00560846

Sponsor

Dan Azagury

Status

Terminated

Last Update Posted

Sep 5, 2013Estimated

Enrollment

43Actual

Phase

Not Applicable

Conditions

Stomach Neoplasms
Esophageal Neoplasms

Interventions

Impact
Glucose load

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment over time.

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Nov 19, 2007

First Submission Date that Met QC Criteria

Nov 19, 2007

First Posted Date

Nov 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2013

Last Update Posted Date

Sep 5, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutrition	Experimental	Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition	Dietary Supplement: Impact Dietary Supplement: Glucose load
Control	No Intervention	No immunonutrition, no glucose load, no early enteral immunonutrition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Impact	Dietary Supplement	Preoperative 5 day oral Impact and early post-operative enteral Impact	Nutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of post-operative complications		30 days
Length of stay		30 days

Secondary Outcomes

Measure	Description	Time Frame
Quality of life		1 year
Body composition		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dan E Azagury, MD	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpitaux Universitaires Genève		Geneva	Canton of Geneva	1204	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided