Overview

This trial is active, not recruiting.

Conditions colon cancer, benign colon diseases
Treatment elective colon resection
Phase phase 0
Sponsor Ostfold Hospital Trust
Start date January 2010
End date December 2016
Trial size 4 participants
Trial identifier NCT01419860, Microcirculation of colon

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Pixel intensity of fluorescence signal describing pixel microcirculation of colon
elective colon resection Surgical colon operations
In our scientific experiment, we evaluate microcirculation in colon wall and anastomosis with laser induced fluorescence videoangiography of ICG. By implementing this technique we can measure average pixel intensity of fluorescence signal in area of interest on bowel, which represents tissue perfusion in this respective part of intestinal wall.

Primary Outcomes

Measure
Evaluation of microcirculation in colon wall and bowel anastomosis by laser induced fluorescence video angiography of indocyanine green
time frame: 2 min

Secondary Outcomes

Measure
Predicting perfusion deficit with laser-induced ICG fluorescence video angiography
time frame: 2 min

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green
Principal investigator Muiz A. Chaudhry, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ostfold Hospital Trust.