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

Chronic Upper Gastrointestinal Hemorrhage Clinical Trial

— ANOM  

Official title:

Peri-operative Usage of Enteric Immune-nutrition Formula (ANOM®) Versus Standard Formula for Patients Received Major Upper Gastrointestinal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01351883
• Other study ID #: HR-98-089
• Status: Recruiting
• Phase: Phase 3
• First received: January 31, 2011
• Last updated: May 10, 2011
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: National Cheng-Kung University Hospital
• Contact: Yan-Shen Shan, MD,PhD
• Phone: 88662353535
• Email: ysshan[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Upper Gastrointestinal Hemorrhage
• Gastrointestinal Hemorrhage

Intervention

Dietary Supplement:
• ANOM
the ANOM was given 800ml per day before operation, and added from POD2 to POD 14 gradually from 400ml to 1200ml

Locations

Country	Name	City	State
Taiwan	Department of Surgery, Tainan Hospital, Department of Health, Executive Yuan	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative infectious complication	we want to evaluate the effect of ANOM on postoperative infectious complication after early feeding with ANOM	POD 14 or discharged day	Yes
Secondary	immunological parameters	we want to compare the immunological parameters, IL-6, with stand diet group	POD 14 or discharged day	No
Secondary	Free radicles -TBARS	we will esitimate the difference blood level of free radicles by ELISA and compared with that in the standard diet group	POD 14 or discharged day	No
Secondary	immunological parameters	we will compare the immunological parameters, IL-8, with the stand diet group.	POD14 or discharged day	No
Secondary	immunological parameter	We will compare the immunological parameter, IL-1, with the standard diet group	POD14 or discharged day	No
Secondary	immunological parameter	We will compare the immunological parameter, IL-10, with the standard diet group	POD14 or discharged day	No
Secondary	immunological parameters	We will compare the immunological parameter, TNF-a, with the standard diet group	POD14 or discharged day	No