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

20 Years
80 Years
Open (Enrolling)
Colonic Neoplasms

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Trial Information

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

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

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.

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.

Patients with the clinical diagnosis of colorectal cancer based on colonoscopy following
histological confirmation will recruited. They should be suitable for elective surgical
resection of the tumour along with lymph node dissection by right and left hemicolectomy,
sigmoid colectomy, and anterior resection. Clinicopathologic characteristics of these
patients will be investigated based on TNM classification of malignant tumours and
modified Dukes classification Inclusion criteria; age between 18 and 80 years; colorectal
cancer with single tumour locating at cecum, ascending colon, descending colon, sigmoid
colon or recto sigmoid junction (distance from anal verge more than 15 cm); ASA I-III; and
informed consent.

Exclusion criteria; patient refusal to participate in the prospective data collection;
prior midline laparotomy; emergency surgery or urgent operation within 24 h after
admission to the hospital; conversion to laparotomy; mechanic ileus; perforation or
abscess with septic inflammatory response syndrome; planned stoma, low anterior resection
or rectal extirpation; known immunological dysfunction (human immunodeficiency virus
infection); presence of ongoing infection or infective chronic diseases; severe
cardiovascular disease (New York Heart Association class higher than 3) or pulmonary
insufficiency (severe pulmonary emphysema, interstitial pneumonitis, arterial PO2<79
mmHg); advanced liver disease (Child-Pugh class C); synchronous or metachronous (within
five years) malignancy; pregnant or lactating women; continuous systemic steroid therapy;
drug addiction; previous chemotherapy, radiotherapy or immune therapy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

24 hours before surgery, 72 hours after surgery

Safety Issue:


Principal Investigator

Igor Stipančić, MD, PhD, Profssor

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Dubrava


Croatia: Ministry of Science, Education and Sports

Study ID:




Start Date:

January 2008

Completion Date:

June 2010

Related Keywords:

  • Colonic Neoplasms
  • Curative surgical resection
  • Laparoscopic technique
  • Neoplasms
  • Colonic Neoplasms