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

Phase 3

• Conditions: Chronic Upper Gastrointestinal Hemorrhage
• Interventions: Dietary Supplement: ANOM

• Registration Number: NCT01351883
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2011-01
• Study First Submitted: 2011-01-31
• Status Verified: 2011-05
• Study First Submitted QC: 2011-05-10
• Last Update Submitted: 2011-05-10
• Study First Posted: 2011-05-11
• Last Update Posted: 2011-05-11
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard enteral nutrition supplement	ANOM	regular standard enteral nutrition(SEN) was made by hospital for patient

Primary Outcome Measures

Name	Time	Method
postoperative infectious complication	POD 14 or discharged day	we want to evaluate the effect of ANOM on postoperative infectious complication after early feeding with ANOM

Secondary Outcome Measures

Name	Time	Method
immunological parameters	POD14 or discharged day	We will compare the immunological parameter, TNF-a, with the standard diet group
Free radicles -TBARS	POD 14 or discharged day	we will esitimate the difference blood level of free radicles by ELISA and compared with that in the standard diet group
immunological parameter	POD14 or discharged day	We will compare the immunological parameter, IL-10, with the standard diet group

Trial Locations

Locations (2)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Department of Surgery, Tainan Hospital, Department of Health, Executive Yuan; 🇨🇳 Tainan, Taiwan