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

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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Upper Gastrointestinal Hemorrhage
• Intervention / Treatment: Dietary supplement: ANOM

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 Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 70428
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Yan-Shen Shan, MD,PhD; Phone Number: 5181 88662353535; Email: ysshan@mail.ncku.edu.tw
    • Principal Investigator: Yan-Shen Shan, MD,PhD
    • Sub-Investigator: Pin-wen Lin, MD
    • Sub-Investigator: Ai-Wen Kao, MD
  • Tainan, Taiwan, 704
    • Recruiting
    • Department of Surgery, Tainan Hospital, Department of Health, Executive Yuan
    • Contact: Kai-Hsi Hsu, MD,PhD
    • Principal Investigator: Kai-Hsi Hsu, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: Yan-Shen Shan, MD, PhD, National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): May 11, 2011
• Last Update Submitted That Met QC Criteria: May 10, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: postoperative infection; immunomodulating diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: HR-98-089