Clinical trial NCT01419860: Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography
Official title: Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Benign Colon Diseases
Keywords: Microcirculation
Colon
Anastomosis
ICG
Gastro surgery
benign colon diseases requiring resection
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to describe utility of dynamic fluorescence videoangiography of indocyanine green (ICG) in gastrointestinal surgery, for evaluation of microcirculation in colon wall and anastomosis before and after surgical resection; and if this technique can guide the surgeon to peroperative decision making considering recreate a new anastomosis or stoma for preventing anastomotic failure or stomia necrosis.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with colon cancer requiring elective surgical operation.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of microcirculation in colon wall and bowel anastomosis by laser induced fluorescence video angiography of indocyanine green
timeFrame: 2 min
Secondary outcomes:
measure: Predicting perfusion deficit with laser-induced ICG fluorescence video angiography
timeFrame: 2 min
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Østfold Hospital Trust HF
state: Østfold
Study officials:
affiliation: Ostfold Hospital Trust HF
name: Muiz A. Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
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