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

Primary Purpose

Colon Cancer, Benign Colon Diseases

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Elective colon resection
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colon Cancer focused on measuring Microcirculation, Colon, Anastomosis, ICG, Gastro surgery, benign colon diseases requiring resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Østfold Hospital Trust HF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pixel intensity

Arm Description

Pixel intensity of fluorescence signal describing pixel microcirculation of colon

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 30, 2011
Last Updated
April 26, 2022
Sponsor
Ostfold Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01419860
Brief Title
Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography
Official Title
Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Benign Colon Diseases
Keywords
Microcirculation, Colon, Anastomosis, ICG, Gastro surgery, benign colon diseases requiring resection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pixel intensity
Arm Type
Experimental
Arm Description
Pixel intensity of fluorescence signal describing pixel microcirculation of colon
Intervention Type
Procedure
Intervention Name(s)
Elective colon resection
Other Intervention Name(s)
Surgical colon operations, Right sided hemicolectomy, Left sided hemicolectomy, Sigmoideum resection, Subtotal colon resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of microcirculation in colon wall and bowel anastomosis by laser induced fluorescence video angiography of indocyanine green
Description
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.
Time Frame
2 min
Secondary Outcome Measure Information:
Title
Predicting perfusion deficit with laser-induced ICG fluorescence video angiography
Description
New method for predicting perfusion deficits and peroperative guide the surgeon in decision to recreate a new anastomosis or stoma.
Time Frame
2 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muiz A. Chaudhry, MD
Organizational Affiliation
Ostfold Hospital Trust HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Østfold Hospital Trust HF
City
Fredrikstad
State/Province
Østfold
ZIP/Postal Code
1603
Country
Norway

12. IPD Sharing Statement

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Links:
URL
http://pubmed.gov
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Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography

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