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Standard and Immunostimulating Enteral Nutrition in Surgical Patients (ImmuniEteral)

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT00576940
First received: December 18, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

The aim of the study was to assess the clinical effect of immunomodulating enteral nutrition in patients undergoing resection for gastrointestinal cancer. 196 subjects were randomly assigned into two study groups: standard and immunostimulating. The study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery


Condition Intervention Phase
Gastric Cancer
Pancreatic Cancer
Drug: Reconvan
Drug: Peptisorb
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Standard and Immunostimulating Enteral Nutrition in Patients After Extended Gastrointestinal Surgery - A Prospective, Randomized, Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • The ratio of postoperative complications (infectious and surgical) [ Time Frame: Postoperative complications ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • length of hospital stay [ Time Frame: length of hospital stay ] [ Designated as safety issue: No ]
  • function of immune system [ Time Frame: function of immune system ] [ Designated as safety issue: No ]
  • assessment of liver and kidney function [ Time Frame: assessment of liver and kidney function ] [ Designated as safety issue: Yes ]
  • determination of the treatment tolerance [ Time Frame: determination of the treatment tolerance ] [ Designated as safety issue: Yes ]
  • assessment of visceral protein turnover [ Time Frame: assessment of visceral protein turnover ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: June 2004
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: IMEN: 1
Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)
Drug: Reconvan
isocaloric, immunomodulating entral diet
Other Name: oligopeptic immunostimulatory diet
Active Comparator: SEN
postoperative enteral nutrition - standard oligopeptic diet
Drug: Peptisorb
isocaloric, isopeptic standard diet
Other Name: standard enetral diet

Detailed Description:

Background&Aim: The administration of immunomodulating enteral diets during postoperative period in patients after major gastrointestinal surgery is intended to reduce the number of postoperative complications and to shorten the hospital stay. The aim of the study was to assess the clinical effect of enteral immunostimulatory nutrition in surgical patients.

Material and Methods: 196 patients undergoing resection for pancreatic and gastric cancer were randomized in double-blind manner to receive early postoperative enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids) or oligopeptic control (SEN group) between June 2004 and September 2007. Enteral nutrition was started 6 hours after surgery and continued for 7 days, up to target volume of 100 ml/h. All malnourished patients requiring preoperative nutritional therapy were excluded for the study and treated preoperatively. Outcome measures were: number and type of complications, length of hospital stay, mortality, treatment tolerance, liver and kidney function.

Results: One hundred eighty-three patients (91 in SEN, 92 in IMEN group, 69 F, 114 M, mean age 61.2) of 196 initially enrolled were analyzed. There were 2 deaths in both groups. Median postoperative hospital stay was 12.4 days (SD 5.9) in SEN group and 12.9 days (SD 8.0) in IMEN group (p=0.42). Complications were observed in 21 patients (23.1%) in SEN and 23 (25.2%) in IMEN group (p>0.05). 4 (4.4%) patients in SEN group and 4 (4.4%) in IMEN had surgical complications (p>0.05). There were no differences in liver and kidney function, visceral protein concentration and treatment tolerance.

Conclusion: Clinical and laboratory parameters show no benefit of immunomodulating enteral nutrition over standard enteral nutrition in patients after major gastrointestinal surgery as far as complications, hospital stay, mortality and treatment tolerance and safety are considered.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18-80 years undergoing subtotal and total gastric resection with lymphadenectomy and pancreatoduodenectomy/ total pancreatectomy with lymphadenectomy, in good general status (Karnofsky > 80, Eastern Cooperative Oncology Group (ECOG) grade 0 or 1); with no confirmed neoplastic dissemination nor distant metastases
  • No severe concomitant disease (heart failure, chronic obstructive pulmonary disease [COPD], coronary aortic bypass graft [CABG], etc.)
  • No history of known allergies or drug intolerance

Exclusion Criteria:

  • Patients with metastatic or unresectable disease
  • Pregnant
  • In poor general status (Karnofsky <80, Eastern Cooperative Oncology Group (ECOG) > 1)
  • With recent history of severe heart, lung, kidney or liver failure
  • With history of allergies or drug intolerance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576940

Locations
Poland
1st Deparment of General Surgery
Krakow, Krkaow, Poland, 30-798
Sponsors and Collaborators
Jagiellonian University
Investigators
Study Chair: Jan Kulig, MD, PhD 1st Department of General Surgery
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 1st Department of Surgery, Jagiellonian University
ClinicalTrials.gov Identifier: NCT00576940     History of Changes
Other Study ID Numbers: 1st Dept Surg Enteral, Immunoenteral
Study First Received: December 18, 2007
Last Updated: December 18, 2007
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
enteral nutrition, immunomodulating nutrition

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on November 23, 2014