Standard and Immunostimulating Enteral Nutrition in Surgical Patients

Phase 4

Completed

• Conditions: Gastric Cancer; Pancreatic Cancer
• Interventions: Drug: Reconvan; Drug: Peptisorb

• Registration Number: NCT00576940
• Lead Sponsor: Jagiellonian University

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

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.

Study Timeline

• Study Start: 2004-06
• Status Verified: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Last Update Submitted: 2007-12-18
• Study First Posted: 2007-12-19
• Last Update Posted: 2007-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMEN: 1	Reconvan	Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)
SEN	Peptisorb	postoperative enteral nutrition - standard oligopeptic diet

Primary Outcome Measures

Name	Time	Method
The ratio of postoperative complications (infectious and surgical)	Postoperative complications

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

1st Deparment of General Surgery; 🇵🇱 Krakow, Krkaow, Poland