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Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Benign Colon Diseases

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Trial Information

Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green


In our study the investigators prospectively include patients with colon cancer requiring
elective surgical operation. All types of colon resection were carried out according to
standard procedures. Guidelines for preoperative examination according to NGICG (Norwegian
Gastro-Intestinal Cancer Group) to grade the disease, select the most suitable patients and
plan further treatment.

Microcirculation of colon wall was assessed by dynamic
laser-induced-fluorescence-videoangiography (IC-VIEW, PULSION Medical Systems AG, Munich,
Germany) of indocyanine green (ICG). ICG is a water-soluble tricarbocyanine dye that binds
strongly to plasma proteins after intravenous injection and is exclusively distributed in
intravascular space. Additionally this system houses a laser (energy Pi = 0.16 W, wavelength
= 780 nm) that causes excitation/illumination of the fluorescence light from intravascular
plasma bound ICG. This light has a spectral range near-infrared energy (NIR) with a maximum
at 805 nm and emits fluorescence at 835 nm. It passes through infrared filter on a digital
video camera and results in recording of real time fluorescent image from perfusion of
plasma bound ICG within small plexus of blood vessels in the bowel wall. Besides that it
also demonstrates perfusion from surrounding structures such as appendix epiploic and
pericolic fat. The maximum penetration of the laser into tissue is 3-5 mm and general normal
thickness of colon wall is 3-5 mm. This method makes it a presentable tracer for tissue
perfusion of anterior bowel wall.


Inclusion Criteria:



- Patients with colon cancer requiring elective surgical operation.

Exclusion Criteria:

- Coloanal anastomosis/LAR

- Pregnancy

- Children or patients below the age of 18 years

- Advanced renal or hepatic failure

- Previous allergic reactions to ICG and iodide

- Chronic anemia

- Active haematologic disease

- Women of fertile age needed a negative pregnancy test to be included

- Patients with previous colectomy or anorectal surgery were also excluded due to
anatomical insult on mesenterial circulation

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Evaluation of microcirculation in colon wall and bowel anastomosis by laser induced fluorescence video angiography of indocyanine green

Outcome Description:

The purpose of our study is to evaluate the microcirculation in the colon wall and bowel anastomosis with laser-induced-fluorescence videoangiography of indocyanine green (ICG), before and after bowel resection.

Outcome Time Frame:

2 min

Safety Issue:

Yes

Principal Investigator

Muiz A. Chaudhry, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ostfold Hospital Trust HF

Authority:

Norway:National Committee for Medical and Health Research Ethics

Study ID:

Microcirculation of colon

NCT ID:

NCT01419860

Start Date:

January 2010

Completion Date:

December 2016

Related Keywords:

  • Colon Cancer
  • Benign Colon Diseases
  • Microcirculation
  • Colon
  • Anastomosis
  • ICG
  • Gastro surgery
  • benign colon diseases requiring resection
  • Colonic Neoplasms
  • Colonic Diseases

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