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

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ClinicalTrials.gov Identifier: NCT01419860
Recruitment Status : Unknown
Verified December 2015 by Ostfold Hospital Trust.
Recruitment status was:  Active, not recruiting
First Posted : August 18, 2011
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Ostfold Hospital Trust

Tracking Information
First Submitted Date  ICMJE June 30, 2011
First Posted Date  ICMJE August 18, 2011
Last Update Posted Date November 1, 2016
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01419860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography
Official Title  ICMJE Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Colon Cancer
  • Benign Colon Diseases
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Pixel intensity
Pixel intensity of fluorescence signal describing pixel microcirculation of colon
Intervention: Procedure: Elective colon resection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 17, 2011)
4
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01419860
Other Study ID Numbers  ICMJE Microcirculation of colon
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ostfold Hospital Trust
Study Sponsor  ICMJE Ostfold Hospital Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muiz A. Chaudhry, MD Ostfold Hospital Trust HF
PRS Account Ostfold Hospital Trust
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP