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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

Brief Summary

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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

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Detailed Description

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Colorectal cancer is the leading cause of death worldwide. Tumour cell extravasation plays a key role in tumour metastasis. There are evidences tumour cell-leukocyte interactions may support tumour cell invasion and could create an optimal microenvironment for tumour growth at the metastatic site. Neutrophils produce free radicals and proteases; they could cause tumour cytolysis, as well as promote tumour growth and metastasis. It seems that neutrophils play an important role in the context of tumour and angiogenesis.

It is not well understood why FasL induces immune privilege in some organs but elicits inflammation. To explain these apparently conflicting phenomena, it is important to investigate the mechanism of FasL-induced inflammation in detail. Fas/FasL can serve as potential targets for effective antitumor therapy. This research will be useful to eludicate the importance of neutrophil in colorectal cancer. We will investigate the possible role of neutrophil activity and FasL-induced neutrophil infiltration on tumor growth in colorectal cancer. sFas and sFasL could be a way to measure the balance of apoptotic and immunoescape effect after surgical resection of colon cancer.

If the number of neutrophils in peripheral blood mirrors the situation in the tumor tissue, these data could support the investigation of neutrophil-targeted therapies in anti-cancer strategy.

Inflammation-dependent angiogenesis seems to be a central force in tumor growth and expansion, a concept supported by the observation that the use of anti-inflammatory drugs, leads to angiogenesis inhibition. The mechanisms of inflammatory angiogenesis could provide new approaches to target, cure, or prevent tumor angiogenesis. Investigation of the physiologic regulation of IL-17 may thus be useful for the treatment in clinical settings characterized by persistent neovascularisation.

Inhibition of neutrophil elastase might not only reduce the inflammatory response, but could also prevent cancer cell progression. Anti-neutrophil elastase therapy after tumour resection might be an important strategic approach for managing postoperative complications and preventing cancer recurrence.

Patients will be allocated to laparoscopic or conventional open colorectal surgery after eligibility had been confirmed and informed consent given. Randomization will be performed by computer; sequencing was based on a list of variable block sizes for a single centre without further stratification. The randomization list and opaque envelopes will be generated by independent personnel not otherwise involved in the trial. Information on the operation will be remain in consecutively numbered and sealed envelopes that will be stored in a specific box at the clinical site. The envelope containing the allocation will be added to a patient's file shortly before he or she enter the operating theatre. The envelope will be then open and the surgeon will perform the assigned procedure. Until the day of discharge of participants, nurses and other medical staff will be blinded for the type of surgery performed in patients with colorectal cancer by applying a covering abdominal bandage.

During the trial, all blood samples will be retrieved and assessed by a cytologist and molecular biologist blinded to the study arms.

Conditions

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Colonic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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ARM I - Open colorectal surgery

Open colorectal surgery

Group Type ACTIVE_COMPARATOR

Therapeutic conventional colorectal surgery

Intervention Type PROCEDURE

Patients with colorectal cancer undergo open laparotomy and colorectal resection

ARM II - Laparoscopic colorectal surgery

Laparoscopic colorectal surgery

Group Type EXPERIMENTAL

Therapeutic laparoscopic colorectal surgery

Intervention Type PROCEDURE

Patients with colorectal cancer undergo laparoscopic colorectal resection

Control - reference value

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.

Group Type OTHER

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

Intervention Type 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)

Interventions

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Therapeutic conventional colorectal surgery

Patients with colorectal cancer undergo open laparotomy and colorectal resection

Intervention Type PROCEDURE

Therapeutic laparoscopic colorectal surgery

Patients with colorectal cancer undergo laparoscopic colorectal resection

Intervention Type PROCEDURE

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

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)

Intervention Type OTHER

Other Intervention Names

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Open colorectal surgery

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes