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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419860
• Other study ID #: Microcirculation of colon
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Colon Diseases
• Colon Cancer
• Colonic Diseases

Intervention

Procedure:
• Elective colon resection
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.

Locations

Country	Name	City	State
Norway	Østfold Hospital Trust HF	Fredrikstad	Østfold

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of microcirculation in colon wall and bowel anastomosis by laser induced fluorescence video angiography of indocyanine green	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.	2 min
Secondary	Predicting perfusion deficit with laser-induced ICG fluorescence video angiography	New method for predicting perfusion deficits and peroperative guide the surgeon in decision to recreate a new anastomosis or stoma.	2 min

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