Stomach NeoplasmsNCT00560846
Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery
A study testing Impact and Glucose load in people with Stomach Neoplasms and Esophageal Neoplasms, run by Dan Azagury at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Esophageal Neoplasms
- What is being tested?
- Impact and Glucose load
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2007to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery for Upper GI cancer
- Age over 18
- Informed consent
Who cannot join
- Major swallowing disorders
- Dementia or other psychological state precluding compliance and understanding of research protocol
- Pre-existing enteral or parenteral nutrition
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires Genève
Geneva, Canton of Geneva, 1204
About this study
Official title: Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)
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.
- Conditions
- Stomach Neoplasms, Esophageal Neoplasms
- Being tested
- Impact, Glucose load
- Keywords
- Gastric cancer, Esophageal cancer, Surgical complications, Immunonutrition
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImpactDietary supplement
Preoperative 5 day oral Impact and early post-operative enteral Impact
Glucose loadDietary supplement
Also called PreOp Nutricia
Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Nutrition | Experimental | Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition Receives: Dietary Supplement: Impact; Dietary Supplement: Glucose load |
| Control | No intervention | No immunonutrition, no glucose load, no early enteral immunonutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative complications
Measured: 30 days
Length of stay
Measured: 30 days
Secondary outcomes (2)
Quality of life
Measured: 1 year
Body composition
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Insufficient recruitment over time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Azagury
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Azagury, University Hospital, Geneva
- Investigators
- Dan E Azagury, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560846
- Sponsor's protocol ID
- CER: 07-123
- Status last verified
- Sep 2013
- First submitted
- 19 Nov 2007
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)
- ClinicalTrials.gov ID
- NCT00560846
- Acronym / sponsor ID
- CER: 07-123
- Conditions
- Stomach Neoplasms, Esophageal Neoplasms
- Keywords
- Gastric cancer, Esophageal cancer, Surgical complications, Immunonutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment over time.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Dan AzaguryUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition | Experimental | Dietary Supplement: Impact, Dietary Supplement: Glucose loadPre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition |
| Control | No intervention | –No immunonutrition, no glucose load, no early enteral immunonutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgery for Upper GI cancer
- Age over 18
- Informed consent
Key exclusion criteria (3 listed)
- Major swallowing disorders
- Dementia or other psychological state precluding compliance and understanding of research protocol
- Pre-existing enteral or parenteral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImpactPreoperative 5 day oral Impact and early post-operative enteral Impact | Dietary supplement | Nutrition |
| Glucose loadAlso: PreOp NutriciaPre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery | Dietary supplement | Nutrition |
Primary outcome
Rate of post-operative complications
Time frame: 30 days
Length of stay
Time frame: 30 days
2 secondary outcomes
Quality of life
Time frame: 1 year
Body composition
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Insufficient recruitment over time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan E Azagury, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact and Glucose load in people with Stomach Neoplasms and Esophageal Neoplasms, run by Dan Azagury at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment over time.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-operative complications (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.