Double Blinded Randomized Clinical Trial of the Effect of Open Versus Laparoscopic Colectomy on Neutrophils in Patients With Colon Cancer

NCT00860691 | Unknown DMC

• 1 other identifier: 198-0000000-3104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

• to determine neutrophil activity in patients with colon cancer,
• to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon cancer patients and establish its prognostic value,
• to elucidate the relationship between serum sFas, sFasL and IL - 17 levels and clinicopathologic features of colon cancer,
• to compare the influence of laparoscopic and conventional procedures on postoperative serum sFas and sFasL levels in colon cancer patients
• to compare the influence of laparoscopic and conventional procedures on postoperative serum IL - 17 levels in colon cancer patients
• to compare the influence of laparoscopic and conventional procedures on postoperative neutrophil functions
• to confirm the expression of FasL protein in human colorectal cancer and elucidate the relationship between FasL expression and clinicopathologic features of the disease, to establish the prevalence of Fas in primary colon adenocarcinomas and elucidate the relationship between FasL expression and clinicopathologic features of the disease
• to determine the functional activity of tumour infiltrating neutrophils

Conditions

Colonic Neoplasms

Keywords

Curative surgical resection; Laparoscopic technique

Outcome Measures

Primary Outcomes (8)

• Neutrophil activity before and after the open or laparoscopic surgery - Serum concentrations of sFas, sFasL and IL - 17.

  24 hours before surgery, 72 hours after surgery

• Respiratory burst neutrophil production - Bursttest before and after open or laparoscopic surgery

  24 hours before surgery and 2 hours after surgery

• Immunohistochemical detection of FasL in tumor and paratumor areas of colon cancer and normal colon mucosa taken at a distance of 10 cm from the tumor

  after surgery

• Immunohistochemical detection of Fas in tumor and paratumor areas of colon cancer and normal colon mucosa taken at a distance of 10 cm from the tumor

  after surgery

• Immunohistochemical detection of neutrophil elastase in tumor and paratumor areas of colon cancer and normal colon mucosa taken at a distance of 10 cm from the tumor

  after surgery

• Number of leukocytes, neutrophils, lymphocytes and neutrophils/lymphocytes ratio

  24 hours before surgery, 2 hours after surgery, 72 hours after surgery

• CRP

  24 hours before surgery, 72 hours after surgery

• Fe, transferrin, ferritin

  24 hours before surgery, 72 hours after surgery

Secondary Outcomes (10)

• to determine neutrophil activity in patients with colon cancer and healthy volunteers

  24 hours before surgery, 2 hours and 72 hours after surgery

• to compare the influence of laparoscopic and conventional procedures on postoperative neutrophil function

  24 hours before surgery, 2 hours and 72 hours after surgery

• to determine functional activity of tumour infiltrating neutrophils

  after surgery

• to determine an effect of surgery on neutrophil activity

  24 hours before surgery, 2 hours and 72 hours after surgery

• to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon cancer patients and establish its prognostic value

  24 hours before surgery, 2 hours and 72 hours after surgery

Study Arms (3)

ARM I - Open colorectal surgery

ACTIVE COMPARATOR

Open colorectal surgery

Procedure: Therapeutic conventional colorectal surgery

ARM II - Laparoscopic colorectal surgery

EXPERIMENTAL

Laparoscopic colorectal surgery

Procedure: Therapeutic laparoscopic colorectal surgery

Control - reference value

OTHER

Blood samples from healthy volunteers will be obtained at one time point.Peripheral blood samples will be obtained into tubes with no additive (BD Vacutainer System, Plymouth, UK).Samples will be processed to serum. Serum concentrations of sFas will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA)using specific anti-Fas MoAbs, Human sFas Immunoassay. Serum concentrations of sFasL will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fasl MoAbs, Human sFas Immunoassay. Serum concentration of IL - 17 will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using Human IL-17 Immunoassay. . Peripheral blood samples for measurement of oxidative burst in neutrophils will be collected into heparinised blood tube. burst neutrophil production will be determined quantitatively by flow cytometry as described by Rothe using a commercial kit Bursttest Kit.

Other: Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest

Interventions

Therapeutic conventional colorectal surgery PROCEDURE

Patients with colorectal cancer undergo open laparotomy and colorectal resection

Also known as: Open colorectal surgery

ARM I - Open colorectal surgery

Therapeutic laparoscopic colorectal surgery PROCEDURE

Patients with colorectal cancer undergo laparoscopic colorectal resection

ARM II - Laparoscopic colorectal surgery

Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest OTHER

Informed consent will be obtained.Blood samples will be obtained at one time point. .Samples will be processed to serum, using a refrigerated centrifuge, then stored at -80C until analysis. Peripheral blood samples for measurement of oxidative burst in neutrophils will be collected into heparinised blood tube.Serum concentrations of sFas will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fas MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R\&D Systems Inc, Minneapolis, USA). Serum concentrations of sFasL will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fasl MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R\&D Systems Inc, Minneapolis, USA).Respiratory burst neutrophil production will be determined quantitatively by flow cytometry using a commercial kit Bursttest Kit (Cat. No: 10-0200; ORPEGEN Pharma, Germany)

Control - reference value

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients will be informed that additional blood and tissue samples will be taken during perioperative period for colon cancer research, and written consent will be obtained. Informed consent will be also obtained from each healthy volunteer.

Sponsors & Collaborators

• University Hospital Dubrava: lead
• Ministry of Science, Education and Sport, Republic of Croatia: collaborator

Study Sites (1)

University Hospital "Dubrava"

Zagreb, 10 000, Croatia

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Igor Stipančić, MD, PhD, Profssor

  University Hospital Dubrava

  STUDY CHAIR

• Valentina Ratkajec, MD

  University Hospital Dubrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Stipancic, MD, PhD, Professor

CONTACT

+3851290 2517; igors@kbd.hr

Valentina Ratkajec, MD

CONTACT

+3851290 3612; vratkajec@kbd.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 12, 2009
• Study Start: January 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: June 1, 2010
• Last Updated: March 26, 2010

Record last verified: 2010-03

Locations

CR (1)