Clinical trial NCT01351883: Enteric Immune-nutrition Formula (ANOM®) for Patients Receiving Major Upper Gastrointestinal Surgery
Official title: Peri-operative Usage of Enteric Immune-nutrition Formula (ANOM®) Versus Standard Formula for Patients Received Major Upper Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Upper Gastrointestinal Hemorrhage
Keywords: immunomodulating diet
postoperative infection
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: postoperative infectious complication
timeFrame: POD 14 or discharged day
Secondary outcomes:
measure: immunological parameters
timeFrame: POD 14 or discharged day
measure: Free radicles -TBARS
timeFrame: POD 14 or discharged day
measure: immunological parameters
timeFrame: POD14 or discharged day
measure: immunological parameter
timeFrame: POD14 or discharged day
measure: immunological parameter
timeFrame: POD14 or discharged day
measure: immunological parameters
timeFrame: POD14 or discharged day
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Department of Surgery, Tainan Hospital, Department of Health, Executive Yuan
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Yan-Shen Shan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: