Standard and Immunostimulating Enteral Nutrition in Surgical Patients

NCT00576940 | Completed Phase 4

• 2 other identifiers: 1st Dept Surg EnteralImmunoenteral
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer; Pancreatic Cancer

Keywords

enteral nutrition, immunomodulating nutrition

Outcome Measures

Primary Outcomes (1)

• The ratio of postoperative complications (infectious and surgical)

  Postoperative complications

Secondary Outcomes (5)

• length of hospital stay

  length of hospital stay

• function of immune system

  function of immune system

• assessment of liver and kidney function

  assessment of liver and kidney function

• determination of the treatment tolerance

  determination of the treatment tolerance

• assessment of visceral protein turnover

  assessment of visceral protein turnover

Study Arms (2)

IMEN: 1

EXPERIMENTAL

Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)

Drug: Reconvan

SEN

ACTIVE COMPARATOR

postoperative enteral nutrition - standard oligopeptic diet

Drug: Peptisorb

Interventions

Reconvan DRUG

isocaloric, immunomodulating entral diet

Also known as: oligopeptic immunostimulatory diet

IMEN: 1

Peptisorb DRUG

isocaloric, isopeptic standard diet

Also known as: standard enetral diet

SEN

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

1st Deparment of General Surgery

Krakow, Krkaow, 30-798, Poland

Location

Related Publications (4)

• Braga M, Gianotti L, Nespoli L, Radaelli G, Di Carlo V. Nutritional approach in malnourished surgical patients: a prospective randomized study. Arch Surg. 2002 Feb;137(2):174-80. doi: 10.1001/archsurg.137.2.174.

  PMID: 11822956 RESULT

• Klek S, Szybinski P, Szczepanek K. Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research. World J Surg. 2014 Apr;38(4):803-12. doi: 10.1007/s00268-013-2323-z.

  PMID: 24178185 DERIVED

• Klek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. The immunomodulating enteral nutrition in malnourished surgical patients - a prospective, randomized, double-blind clinical trial. Clin Nutr. 2011 Jun;30(3):282-8. doi: 10.1016/j.clnu.2010.10.001. Epub 2010 Nov 13.

  PMID: 21074910 DERIVED

• Klek S, Kulig J, Sierzega M, Szczepanek K, Szybinski P, Scislo L, Walewska E, Kubisz A, Szczepanik AM. Standard and immunomodulating enteral nutrition in patients after extended gastrointestinal surgery--a prospective, randomized, controlled clinical trial. Clin Nutr. 2008 Aug;27(4):504-12. doi: 10.1016/j.clnu.2008.04.010. Epub 2008 Jun 20.

  PMID: 18571296 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jan Kulig, MD, PhD

  1st Department of General Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 19, 2007
• Study Start: June 1, 2004
• Study Completion: September 1, 2007
• Last Updated: December 19, 2007

Record last verified: 2007-09

Locations

PL (1)