Standard and Immunostimulating Enteral Nutrition in Surgical Patients

Pancreatic Cancer Clinical Trial

— ImmuniEteral  

Official title:

Standard and Immunostimulating Enteral Nutrition in Patients After Extended Gastrointestinal Surgery - A Prospective, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576940
• Other study ID #: 1st Dept Surg Enteral
• Secondary ID: Immunoenteral
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2007
• Last updated: December 18, 2007
• Start date: June 2004
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Reconvan
isocaloric, immunomodulating entral diet
• Peptisorb
isocaloric, isopeptic standard diet

Locations

Country	Name	City	State
Poland	1st Deparment of General Surgery	Krakow	Krkaow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of postoperative complications (infectious and surgical)		Postoperative complications	Yes
Secondary	length of hospital stay		length of hospital stay	No
Secondary	function of immune system		function of immune system	No
Secondary	assessment of liver and kidney function		assessment of liver and kidney function	Yes
Secondary	determination of the treatment tolerance		determination of the treatment tolerance	Yes
Secondary	assessment of visceral protein turnover		assessment of visceral protein turnover	No