Chronic Upper Gastrointestinal HemorrhagePhase 3ANOMNCT01351883
Enteric Immune-nutrition Formula (ANOM®) for Patients Receiving Major Upper Gastrointestinal Surgery
A Phase 3 study testing ANOM in people with Chronic Upper Gastrointestinal Hemorrhage, run by National Cheng-Kung University Hospital at 2 sites in Taiwan.
Trial summary
Perioperative usage of immunonutrition (ANOM®) can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery. (ANOM®)immunonutrition product name Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Upper Gastrointestinal Hemorrhage
- What is being tested?
- ANOM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2010to Dec 2011
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranged from 18 to 80 years old
- Patients with upper gastrointestinal diseases, and was planning to receive elective major upper gastrointestinal tract surgery, such as subtotal gastrectomy, proximal gastrectomy, total gastrectomy, esophagectomy, pancreatectomy, pancreaticoduodenectomy, duodenectomy, etc.
- Patient is able to understand the requirements of the study and signs the Informed Consent Form.
Who cannot join
- Patient with severe malnutrition condition, albumin < 2.6mg/ml
- Patient with severe pulmonary, cardiovascular, renal or hepatic disease
- Patient with immunosuppressive therapy or immunological disease recently
- Patient with on-going infection with any condition
- Patient with emergency operation
- Patient with widespread metastatic disease before surgery
- Patient with bowel obstruction disease
- Investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complications)
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan, 70428
Yan-Shen Shan, MD,PhD, 88662353535 ext. 5181, ysshan@mail.ncku.edu.tw
Yan-Shen Shan, MD,PhD
- Recruiting
Department of Surgery, Tainan Hospital, Department of Health, Executive Yuan
Tainan, Taiwan, 704
Kai-Hsi Hsu, MD,PhD
Kai-Hsi Hsu, MD,PhD
About this study
Official title: Peri-operative Usage of Enteric Immune-nutrition Formula (ANOM®) Versus Standard Formula for Patients Received Major Upper Gastrointestinal Surgery
Perioperative usage of immunonutrition (ANOM®) can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery.
(ANOM®)immunonutrition product name
Read the detailed description
Background: Perioperative usage of immunonutrition can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery. The aim of this study was to elucidate the effect of immunomodulating diets, ANOM®, on surgical outcome in elective major upper gastrointestinal tract operations.
Material and Methods:
Design: Prospective, randomized, controlled trial. Participants: Seventy upper gastrointestinal tract cancer patients planned to undergo major upper gastrointestinal surgery in eesophagus、stomach、pancreas or duodenum, Interventions: Patients will be divided randomly into two groups to receive ANOM® or standard diet. Before surgery, 800ml ANOM® or standard diet (SEN) will be given for 5 days by mouth. After operation, 5% Distill water (D5W) combined with ANOM® or standard diet since the 2nd post-operation day (POD2) until day 14 (POD14) or until discharged day by enteric route using nasogastric tube(NG) tube or jejunostomy. Postoperative parenteral nutrition will be given to maintain adequate nutrition.
Clinical Assessment: The preoperative and postoperative immunological parameters, infection complications, and hospital stay will be compared.
- Being tested
- ANOM
- Keywords
- immunomodulating diet, postoperative infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANOMDietary supplement
the ANOM was given 800ml per day before operation, and added from POD2 to POD 14 gradually from 400ml to 1200ml
| Study group | Role | What they receive |
|---|---|---|
| Standard enteral nutrition supplement | No intervention | regular standard enteral nutrition(SEN) was made by hospital for patient Receives: Dietary Supplement: ANOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative infectious complication
we want to evaluate the effect of ANOM on postoperative infectious complication after early feeding with ANOM
Measured: POD 14 or discharged day
Secondary outcomes (6)
immunological parameters
we want to compare the immunological parameters, IL-6, with stand diet group
Measured: POD 14 or discharged day
Free radicles -TBARS
we will esitimate the difference blood level of free radicles by ELISA and compared with that in the standard diet group
Measured: POD 14 or discharged day
immunological parameters
we will compare the immunological parameters, IL-8, with the stand diet group.
Measured: POD14 or discharged day
immunological parameter
We will compare the immunological parameter, IL-1, with the standard diet group
Measured: POD14 or discharged day
immunological parameter
We will compare the immunological parameter, IL-10, with the standard diet group
Measured: POD14 or discharged day
immunological parameters
We will compare the immunological parameter, TNF-a, with the standard diet group
Measured: POD14 or discharged day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Upper Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yan-Shen Shan, MD, PhD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351883
- Sponsor's protocol ID
- HR-98-089
- Acronym
- ANOM
- Status last verified
- May 2011
- First submitted
- 31 Jan 2011
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Usage of Enteric Immune-nutrition Formula (ANOM®) Versus Standard Formula for Patients Received Major Upper Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT01351883
- Acronym / sponsor ID
- ANOM / HR-98-089
- Keywords
- immunomodulating diet, postoperative infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 11 May 2011 (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.
Perioperative usage of immunonutrition (ANOM®) can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery.
(ANOM®)immunonutrition product name
Detailed description
Background: Perioperative usage of immunonutrition can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery. The aim of this study was to elucidate the effect of immunomodulating diets, ANOM®, on surgical outcome in elective major upper gastrointestinal tract operations.
Material and Methods:
Design: Prospective, randomized, controlled trial. Participants: Seventy upper gastrointestinal tract cancer patients planned to undergo major upper gastrointestinal surgery in eesophagus、stomach、pancreas or duodenum, Interventions: Patients will be divided randomly into two groups to receive ANOM® or standard diet. Before surgery, 800ml ANOM® or standard diet (SEN) will be given for 5 days by mouth. After operation, 5% Distill water (D5W) combined with ANOM® or standard diet since the 2nd post-operation day (POD2) until day 14 (POD14) or until discharged day by enteric route using nasogastric tube(NG) tube or jejunostomy. Postoperative parenteral nutrition will be given to maintain adequate nutrition.
Clinical Assessment: The preoperative and postoperative immunological parameters, infection complications, and hospital stay will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard enteral nutrition supplement | No intervention | Dietary Supplement: ANOMregular standard enteral nutrition(SEN) was made by hospital for patient |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ranged from 18 to 80 years old
- Patients with upper gastrointestinal diseases, and was planning to receive elective major upper gastrointestinal tract surgery, such as subtotal gastrectomy, proximal gastrectomy, total gastrectomy, esophagectomy, pancreatectomy, pancreaticoduodenectomy, duodenectomy, etc.
- Patient is able to understand the requirements of the study and signs the Informed Consent Form.
Key exclusion criteria (8 listed)
- Patient with severe malnutrition condition, albumin < 2.6mg/ml
- Patient with severe pulmonary, cardiovascular, renal or hepatic disease
- Patient with immunosuppressive therapy or immunological disease recently
- Patient with on-going infection with any condition
- Patient with emergency operation
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 |
|---|---|---|
| ANOMthe ANOM was given 800ml per day before operation, and added from POD2 to POD 14 gradually from 400ml to 1200ml | Dietary supplement | Standard enteral nutrition supplement |
Primary outcome
postoperative infectious complication
Time frame: POD 14 or discharged day
we want to evaluate the effect of ANOM on postoperative infectious complication after early feeding with ANOM
6 secondary outcomes
immunological parameters
Time frame: POD 14 or discharged day
Free radicles -TBARS
Time frame: POD 14 or discharged day
immunological parameters
Time frame: POD14 or discharged day
immunological parameter
Time frame: POD14 or discharged day
immunological parameter
Time frame: POD14 or discharged day
immunological parameters
Time frame: POD14 or discharged day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
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.
Yan-Shen Shan, MD, PhD principal investigator
National Cheng-Kung University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ANOM in people with Chronic Upper Gastrointestinal Hemorrhage, run by National Cheng-Kung University Hospital at 2 sites in Taiwan.
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 8 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: status not confirmed, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan-Shen Shan, MD,PhD (88662353535 ext. 5181, ysshan@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative infectious complication (time frame: POD 14 or discharged day). 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 11 May 2011.