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Enteric Immune-nutrition Formula (ANOM®) for Patients Receiving Major Upper Gastrointestinal Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Cheng-Kung University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01351883
First received: January 31, 2011
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Upper Gastrointestinal Hemorrhage
 Dietary Supplement: ANOM
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Peri-operative Usage of Enteric Immune-nutrition Formula (ANOM®) Versus Standard Formula for Patients Received Major Upper Gastrointestinal Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • postoperative infectious complication [ Time Frame: POD 14 or discharged day ] [ Designated as safety issue: Yes ]
    we want to evaluate the effect of ANOM on postoperative infectious complication after early feeding with ANOM


Secondary Outcome Measures:
  • immunological parameters [ Time Frame: POD 14 or discharged day ] [ Designated as safety issue: No ]
    we want to compare the immunological parameters, IL-6, with stand diet group

  • Free radicles -TBARS [ Time Frame: POD 14 or discharged day ] [ Designated as safety issue: No ]
    we will esitimate the difference blood level of free radicles by ELISA and compared with that in the standard diet group

  • immunological parameters [ Time Frame: POD14 or discharged day ] [ Designated as safety issue: No ]
    we will compare the immunological parameters, IL-8, with the stand diet group.

  • immunological parameter [ Time Frame: POD14 or discharged day ] [ Designated as safety issue: No ]
    We will compare the immunological parameter, IL-1, with the standard diet group

  • immunological parameter [ Time Frame: POD14 or discharged day ] [ Designated as safety issue: No ]
    We will compare the immunological parameter, IL-10, with the standard diet group

  • immunological parameters [ Time Frame: POD14 or discharged day ] [ Designated as safety issue: No ]
    We will compare the immunological parameter, TNF-a, with the standard diet group


Estimated Enrollment: 64
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard enteral nutrition supplement
regular standard enteral nutrition(SEN) was made by hospital for patient
 Dietary Supplement: ANOM
the ANOM was given 800ml per day before operation, and added from POD2 to POD 14 gradually from 400ml to 1200ml

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ranged from 18 to 80 years old
  2. 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.
  3. Patient is able to understand the requirements of the study and signs the Informed Consent Form.

Exclusion Criteria:

  1. Patient with severe malnutrition condition, albumin < 2.6mg/ml
  2. Patient with severe pulmonary, cardiovascular, renal or hepatic disease
  3. Patient with immunosuppressive therapy or immunological disease recently
  4. Patient with on-going infection with any condition
  5. Patient with emergency operation
  6. Patient with widespread metastatic disease before surgery
  7. Patient with bowel obstruction disease
  8. Investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complications)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351883

Contacts
Contact: Yan-Shen Shan, MD,PhD 88662353535 ext 5181 ysshan@mail.ncku.edu.tw

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70428
Contact: Yan-Shen Shan, MD,PhD     88662353535 ext 5181     ysshan@mail.ncku.edu.tw    
Principal Investigator: Yan-Shen Shan, MD,PhD            
Sub-Investigator: Pin-wen Lin, MD            
Sub-Investigator: Ai-Wen Kao, MD            
Department of Surgery, Tainan Hospital, Department of Health, Executive Yuan Recruiting
Tainan, Taiwan, 704
Contact: Kai-Hsi Hsu, MD,PhD            
Principal Investigator: Kai-Hsi Hsu, MD,PhD            
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Principal Investigator: Yan-Shen Shan, MD, PhD National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: Benjamin Hsieh/ Product manager, Taiwan Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01351883     History of Changes
Other Study ID Numbers: HR-98-089
Study First Received: January 31, 2011
Last Updated: May 10, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Cheng-Kung University Hospital:
immunomodulating diet
postoperative infection

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013