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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Ostfold Hospital Trust Identifier:
First received: June 30, 2011
Last updated: October 31, 2016
Last verified: December 2015
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.

Condition Intervention Phase
Colon Cancer Benign Colon Diseases Procedure: Elective colon resection Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green

Further study details as provided by Ostfold Hospital Trust:

Primary Outcome Measures:
  • Evaluation of microcirculation in colon wall and bowel anastomosis by laser induced fluorescence video angiography of indocyanine green [ Time Frame: 2 min ]
    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.

Secondary Outcome Measures:
  • Predicting perfusion deficit with laser-induced ICG fluorescence video angiography [ Time Frame: 2 min ]
    New method for predicting perfusion deficits and peroperative guide the surgeon in decision to recreate a new anastomosis or stoma.

Estimated Enrollment: 4
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pixel intensity
Pixel intensity of fluorescence signal describing pixel microcirculation of colon
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.
Other Names:
  • Surgical colon operations
  • Right sided hemicolectomy
  • Left sided hemicolectomy
  • Sigmoideum resection
  • Subtotal colon resection

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01419860

Østfold Hospital Trust HF
Fredrikstad, Østfold, Norway, 1603
Sponsors and Collaborators
Ostfold Hospital Trust
Principal Investigator: Muiz A. Chaudhry, MD Ostfold Hospital Trust HF
  More Information

Additional Information:

Responsible Party: Ostfold Hospital Trust Identifier: NCT01419860     History of Changes
Other Study ID Numbers: Microcirculation of colon
Study First Received: June 30, 2011
Last Updated: October 31, 2016

Keywords provided by Ostfold Hospital Trust:
Gastro surgery
benign colon diseases requiring resection

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on July 21, 2017