Enteric Immune-nutrition Formula (ANOM®) for Patients Rec... | NCT01351883

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

NCT01351883

Sponsor

National Cheng-Kung University Hospital

Status

Unknown status

Last Update Posted

May 11, 2011Estimated

Enrollment

64Estimated

Phase

Phase 3

Conditions

Chronic Upper Gastrointestinal Hemorrhage

Interventions

ANOM

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Dec 2011Estimated

First Submitted Date

Jan 31, 2011

First Submission Date that Met QC Criteria

May 10, 2011

First Posted Date

May 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2011

Last Update Posted Date

May 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ANOM	Dietary Supplement	the ANOM was given 800ml per day before operation, and added from POD2 to POD 14 gradually from 400ml to 1200ml	Standard enteral nutrition supplement

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yan-Shen Shan, MD,PhD	Contact	88662353535	5181	ysshan@mail.ncku.edu.tw

Overall Officials

Name	Affiliation	Role
Yan-Shen Shan, MD, PhD	National Cheng-Kung University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cheng Kung University Hospital	Recruiting	Tainan	Taiwan	70428	Taiwan