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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Upper Gastrointestinal Hemorrhage

Intervention / Treatment
-----------------
* Dietary Supplement: ANOM


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard enteral nutrition supplement<br>regular standard enteral nutrition(SEN) was made by hospital for patient | Dietary Supplement: ANOM<br>* the ANOM was given 800ml per day before operation, and added from POD2 to POD 14 gradually from 400ml to 1200ml<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunological parameters | we want to compare the immunological parameters, IL-6, with stand diet group | POD 14 or discharged day | 
| 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 | 
| immunological parameters | we will compare the immunological parameters, IL-8, with the stand diet group. | POD14 or discharged day | 
| immunological parameter | We will compare the immunological parameter, IL-1, with the standard diet group | POD14 or discharged day | 
| immunological parameter | We will compare the immunological parameter, IL-10, with the standard diet group | POD14 or discharged day | 
| immunological parameters | We will compare the immunological parameter, TNF-a, with the standard diet group | POD14 or discharged day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunomodulating diet, postoperative infection