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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01419860
First Posted: August 18, 2011
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ostfold Hospital Trust
  Purpose
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: None (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419860


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

Additional Information:
Publications:

Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT01419860     History of Changes
Other Study ID Numbers: Microcirculation of colon
First Submitted: June 30, 2011
First Posted: August 18, 2011
Last Update Posted: November 1, 2016
Last Verified: December 2015

Keywords provided by Ostfold Hospital Trust:
Microcirculation
Colon
Anastomosis
ICG
Gastro surgery
benign colon diseases requiring resection

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases