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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT01419860
First received: June 30, 2011
Last updated: August 17, 2011
Last verified: August 2011
  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
Phase 0

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with colon cancer requiring elective surgical operation.

Exclusion Criteria:

  • Coloanal anastomosis/LAR
  • 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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: Morten Jacobsen/Head of research, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT01419860     History of Changes
Other Study ID Numbers: Microcirculation of colon
Study First Received: June 30, 2011
Last Updated: August 17, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 01, 2014