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Prospective Study of the Effect of Perioperative Immunonutrition on the Immune Host Defense and the Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients.


N/A
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

Prospective Study of the Effect of Perioperative Immunonutrition on the Immune Host Defense and the Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients.


Surgical treatment of gastric cancer is associated with a high risk of perioperative
complications. Morbidity of cancer patients increases in concert with the clinical stage of
the malignancy. It is postulated that a reduction in perioperative morbidity and improved
quality of life of patients with advanced gastric cancer can be achieved by proper
preparation to surgery, among others. One of such methods is the implementation of
immunostimulating nutritional therapy during the perioperative period.The stage of cancer
will be graded according to TNM classification. The patients will be randomly assigned to
four clinical groups based on the type of nutritional therapy implemented.


Inclusion Criteria:



- gastric cancer

Exclusion Criteria:

- for group III constituted gastric cancer associated with severe gastrointestinal
obstruction

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Phagocytic activity of blood platelets in gastric cancer patients.

Outcome Description:

Platelet count and phagocytic activity of thrombocytes will be examined twice in each patient. Blood samples for laboratory tests will be drawn prior to surgery and nutritional therapy and 12 days after the surgery. Thrombocyte count will be determined using Advia 120 haematological analyser. Phagocytic activity of blood platelets will be determined against Staphylococcus aureus ATCC 6538P bacterial strain. It expresses as the fraction of phagocytizing platelets and the phagocytic index. The fraction of phagocytizing platelets corresponds to the percentage of phagocyting thrombocytes per 1000 consecutive cells of this type. The phagocytic index represents the ratio of phagocytized bacteria per 100 phagocytic platelets.

Outcome Time Frame:

Participans will be followed for the duration of hospital stay, an expected average of 3 weeks

Safety Issue:

Yes

Principal Investigator

Zbigniew Kamocki, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

2nd Department of General and Gastrointestinal Surgery Medical University of Bialystok

Authority:

Poland: Ministry of Science and Higher Education

Study ID:

3-37878 L

NCT ID:

NCT01704664

Start Date:

March 2007

Completion Date:

July 2014

Related Keywords:

  • Gastric Cancer
  • malnutrition,
  • perioperative artificial nutrition,
  • immunonutrition,
  • gastrectomy,
  • lymphocytes,
  • interleukin,
  • blood platelets,
  • phagocytic and bactericidal activity of blood platelets
  • Stomach Neoplasms

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