Clinical trial NCT00558155: The Impact of Immunostimulating Nutrition on the Outcome of Surgery
Official title: Title: The Impact of Immunostimulating Nutrition on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Cancer
Pancreatic Cancer
Keywords: immunonutrition
enteral nutrition
parenteral nutrition
surgery
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2007-11-14
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205 subjects were randomly assigned into four study groups, standard and immunostimulating, enteral and parenteral. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery.

Detailed description: All patients qualified between June 2001 and December 2005 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients requiring preoperative nutritional support, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.

After completing tumor resection, patients who met the eligibility criteria were intraoperatively assigned to either of the treatment groups using sealed envelopes containing computer-generated allocation numbers. The following groups were generated: standard enteral nutrition (SEN), immunostimulating enteral nutrition (IMEN), standard parenteral nutrition (SPN), and immunostimulating parenteral nutrition (IMPN). The study was carried out following the international ethical recommendations stated in the Declaration of Helsinki.

Eligibility criteria: Inclusion Criteria:

* resectable gastric or pancreatic cancer
* age between 18 and 80 years,
* Karnofsky performance status score of 80 or more,
* adequate organ function

Exclusion Criteria:

* unresectable gastric or pancreatic cancer
* patients requiring preoperative nutritional support,
* disseminated tumors,
* serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5),
* renal or liver failure were excluded

Primary outcomes:
measure: During the postoperative period, all patients were observed for both surgical and non-surgical complications
timeFrame: 52 months
Secondary outcomes:
measure: The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.
timeFrame: 52 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: 1st Department of General Surgery
Study officials:
affiliation: Jagiellonian University 1 Dept Surgery
name: Stanislaw Klek, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. Perioperative nutrition in malnourished surgical cancer patients - a prospective, randomized, controlled clinical trial. Clin Nutr. 2011 Dec;30(6):708-13. doi: 10.1016/j.clnu.2011.07.007. Epub 2011 Aug 5.
citation: Klek S, Kulig J, Sierzega M, Szybinski P, Szczepanek K, Kubisz A, Kowalczyk T, Gach T, Pach R, Szczepanik AM. The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial. Ann Surg. 2008 Aug;248(2):212-20. doi: 10.1097/SLA.0b013e318180a3c1.