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

N

National Cheng-Kung University

Status and phase

Unknown
Phase 3

Conditions

Chronic Upper Gastrointestinal Hemorrhage

Treatments

Dietary Supplement: ANOM

Study type

Interventional

Funder types

Other

Identifiers

NCT01351883
HR-98-089

Details and patient eligibility

About

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

Full 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.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 1 patient group

Standard enteral nutrition supplement
No Intervention group
Description:
regular standard enteral nutrition(SEN) was made by hospital for patient
Treatment:
Dietary Supplement: ANOM

Trial contacts and locations

0

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Central trial contact

Yan-Shen Shan, MD,PhD

Data sourced from clinicaltrials.gov

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