Colon CancerNCT01419860
Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography
A study testing Elective colon resection in people with Colon Cancer and Benign Colon Diseases, run by Ostfold Hospital Trust at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Benign Colon Diseases
- What is being tested?
- Elective colon resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with colon cancer requiring elective surgical operation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green
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.
Read the 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.
- Conditions
- Colon Cancer, Benign Colon Diseases
- Being tested
- Elective colon resection
- Keywords
- Microcirculation, Colon, Anastomosis, ICG, Gastro surgery, benign colon diseases requiring resection
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective colon resectionProcedure or surgery
Also called Surgical colon operations, Right sided hemicolectomy, Left sided hemicolectomy, Sigmoideum 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.
| Study group | Role | What they receive |
|---|---|---|
| Pixel intensity | Experimental | Pixel intensity of fluorescence signal describing pixel microcirculation of colon Receives: Procedure: Elective colon resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 min
Secondary outcomes (1)
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.
Measured: 2 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muiz A. Chaudhry, MD, Principal investigator, Ostfold Hospital Trust HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419860
- Sponsor's protocol ID
- Microcirculation of colon
- Status last verified
- Dec 2015
- First submitted
- 30 Jun 2011
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marston A. Vascular disorders of the colon. Acta Chir Belg. 1967 Dec 2;Suppl 2:80-92. No abstract available.
PubMed 5621502Massacesi AL, Sacchi L, Bergamini F, Bottoni F. The prevalence of retinal angiomatous proliferation in age-related macular degeneration with occult choroidal neovascularization. Graefes Arch Clin Exp Ophthalmol. 2008 Jan;246(1):89-92. doi: 10.1007/s00417-007-0638-x. Epub 2007 Jul 25.
PubMed 17653567Ba ZF, Yokoyama Y, Toth B, Rue LW 3rd, Bland KI, Chaudry IH. Gender differences in small intestinal endothelial function: inhibitory role of androgens. Am J Physiol Gastrointest Liver Physiol. 2004 Mar;286(3):G452-7. doi: 10.1152/ajpgi.00357.2003. Epub 2003 Oct 16.
PubMed 14563675Handa T, Katare RG, Sasaguri S, Sato T. Preliminary experience for the evaluation of the intraoperative graft patency with real color charge-coupled device camera system: an advanced device for simultaneous capturing of color and near-infrared images during coronary artery bypass graft. Interact Cardiovasc Thorac Surg. 2009 Aug;9(2):150-4. doi: 10.1510/icvts.2008.201418. Epub 2009 May 7.
PubMed 19423513Holm C, Mayr M, Hofter E, Dornseifer U, Ninkovic M. Assessment of the patency of microvascular anastomoses using microscope-integrated near-infrared angiography: a preliminary study. Microsurgery. 2009;29(7):509-14. doi: 10.1002/micr.20645.
PubMed 19306390Pena-Tapia PG, Kemmling A, Czabanka M, Vajkoczy P, Schmiedek P. Identification of the optimal cortical target point for extracranial-intracranial bypass surgery in patients with hemodynamic cerebrovascular insufficiency. J Neurosurg. 2008 Apr;108(4):655-61. doi: 10.3171/JNS/2008/108/4/0655.
PubMed 18377242Murawa D, Hirche C, Dresel S, Hunerbein M. Sentinel lymph node biopsy in breast cancer guided by indocyanine green fluorescence. Br J Surg. 2009 Nov;96(11):1289-94. doi: 10.1002/bjs.6721.
PubMed 19847873Chambers WM, Mortensen NJ. Postoperative leakage and abscess formation after colorectal surgery. Best Pract Res Clin Gastroenterol. 2004 Oct;18(5):865-80. doi: 10.1016/j.bpg.2004.06.026.
PubMed 15494283Alves A, Panis Y, Trancart D, Regimbeau JM, Pocard M, Valleur P. Factors associated with clinically significant anastomotic leakage after large bowel resection: multivariate analysis of 707 patients. World J Surg. 2002 Apr;26(4):499-502. doi: 10.1007/s00268-001-0256-4. Epub 2002 Feb 4.
PubMed 11910487Buchs NC, Gervaz P, Secic M, Bucher P, Mugnier-Konrad B, Morel P. Incidence, consequences, and risk factors for anastomotic dehiscence after colorectal surgery: a prospective monocentric study. Int J Colorectal Dis. 2008 Mar;23(3):265-70. doi: 10.1007/s00384-007-0399-3. Epub 2007 Nov 22.
PubMed 18034250Lustosa SA, Matos D, Atallah AN, Castro AA. Stapled versus handsewn methods for colorectal anastomosis surgery: a systematic review of randomized controlled trials. Sao Paulo Med J. 2002 Sep 2;120(5):132-6. doi: 10.1590/s1516-31802002000500002.
PubMed 12436148Lipska MA, Bissett IP, Parry BR, Merrie AE. Anastomotic leakage after lower gastrointestinal anastomosis: men are at a higher risk. ANZ J Surg. 2006 Jul;76(7):579-85. doi: 10.1111/j.1445-2197.2006.03780.x.
PubMed 16813622Leaper DJ. Angiography as an index of healing in experimental laparotomy wounds and colonic anastomoses. Ann R Coll Surg Engl. 1983 Jan;65(1):20-3.
PubMed 6186177Holm C, Mayr M, Hofter E, Becker A, Pfeiffer UJ, Muhlbauer W. Intraoperative evaluation of skin-flap viability using laser-induced fluorescence of indocyanine green. Br J Plast Surg. 2002 Dec;55(8):635-44. doi: 10.1054/bjps.2002.3969.
PubMed 12550116Muckle TJ. Plasma proteins binding of indocyanine green. Biochem Med. 1976 Feb;15(1):17-21. doi: 10.1016/0006-2944(76)90069-7. No abstract available.
PubMed 942422
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green
- ClinicalTrials.gov ID
- NCT01419860
- Acronym / sponsor ID
- Microcirculation of colon
- Conditions
- Colon Cancer, Benign Colon Diseases
- Keywords
- Microcirculation, Colon, Anastomosis, ICG, Gastro surgery, benign colon diseases requiring resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pixel intensity | Experimental | Procedure: Elective colon resectionPixel intensity of fluorescence signal describing pixel microcirculation of colon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with colon cancer requiring elective surgical operation.
Key exclusion criteria (8 listed)
- Pregnancy
- Children or patients below the age of 18 years
- Advanced renal or hepatic failure
- Previous allergic reactions to ICG and iodide
- Chronic anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective colon resectionAlso: Surgical colon operations, Right sided hemicolectomy, Left sided hemicolectomy, Sigmoideum resectionIn 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. | Procedure or surgery | Pixel intensity |
Primary outcome
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.
1 secondary outcome
Predicting perfusion deficit with laser-induced ICG fluorescence video angiography
Time frame: 2 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Background: PubMed 5621502Marston A. Vascular disorders of the colon. Acta Chir Belg. 1967 Dec 2;Suppl 2:80-92. No abstract available.
- Background: PubMed 17653567Massacesi AL, Sacchi L, Bergamini F, Bottoni F. The prevalence of retinal angiomatous proliferation in age-related macular degeneration with occult choroidal neovascularization. Graefes Arch Clin Exp Ophthalmol. 2008 Jan;246(1):89-92. doi: 10.1007/s00417-007-0638-x. Epub 2007 Jul 25.
- Background: PubMed 14563675Ba ZF, Yokoyama Y, Toth B, Rue LW 3rd, Bland KI, Chaudry IH. Gender differences in small intestinal endothelial function: inhibitory role of androgens. Am J Physiol Gastrointest Liver Physiol. 2004 Mar;286(3):G452-7. doi: 10.1152/ajpgi.00357.2003. Epub 2003 Oct 16.
- Background: PubMed 19423513Handa T, Katare RG, Sasaguri S, Sato T. Preliminary experience for the evaluation of the intraoperative graft patency with real color charge-coupled device camera system: an advanced device for simultaneous capturing of color and near-infrared images during coronary artery bypass graft. Interact Cardiovasc Thorac Surg. 2009 Aug;9(2):150-4. doi: 10.1510/icvts.2008.201418. Epub 2009 May 7.
- Background: PubMed 19306390Holm C, Mayr M, Hofter E, Dornseifer U, Ninkovic M. Assessment of the patency of microvascular anastomoses using microscope-integrated near-infrared angiography: a preliminary study. Microsurgery. 2009;29(7):509-14. doi: 10.1002/micr.20645.
- Background: PubMed 18377242Pena-Tapia PG, Kemmling A, Czabanka M, Vajkoczy P, Schmiedek P. Identification of the optimal cortical target point for extracranial-intracranial bypass surgery in patients with hemodynamic cerebrovascular insufficiency. J Neurosurg. 2008 Apr;108(4):655-61. doi: 10.3171/JNS/2008/108/4/0655.
- Background: PubMed 19847873Murawa D, Hirche C, Dresel S, Hunerbein M. Sentinel lymph node biopsy in breast cancer guided by indocyanine green fluorescence. Br J Surg. 2009 Nov;96(11):1289-94. doi: 10.1002/bjs.6721.
- Results publication: PubMed 15494283Chambers WM, Mortensen NJ. Postoperative leakage and abscess formation after colorectal surgery. Best Pract Res Clin Gastroenterol. 2004 Oct;18(5):865-80. doi: 10.1016/j.bpg.2004.06.026.
- Results publication: PubMed 11910487Alves A, Panis Y, Trancart D, Regimbeau JM, Pocard M, Valleur P. Factors associated with clinically significant anastomotic leakage after large bowel resection: multivariate analysis of 707 patients. World J Surg. 2002 Apr;26(4):499-502. doi: 10.1007/s00268-001-0256-4. Epub 2002 Feb 4.
- Results publication: PubMed 18034250Buchs NC, Gervaz P, Secic M, Bucher P, Mugnier-Konrad B, Morel P. Incidence, consequences, and risk factors for anastomotic dehiscence after colorectal surgery: a prospective monocentric study. Int J Colorectal Dis. 2008 Mar;23(3):265-70. doi: 10.1007/s00384-007-0399-3. Epub 2007 Nov 22.
- Results publication: PubMed 12436148Lustosa SA, Matos D, Atallah AN, Castro AA. Stapled versus handsewn methods for colorectal anastomosis surgery: a systematic review of randomized controlled trials. Sao Paulo Med J. 2002 Sep 2;120(5):132-6. doi: 10.1590/s1516-31802002000500002.
- Results publication: PubMed 16813622Lipska MA, Bissett IP, Parry BR, Merrie AE. Anastomotic leakage after lower gastrointestinal anastomosis: men are at a higher risk. ANZ J Surg. 2006 Jul;76(7):579-85. doi: 10.1111/j.1445-2197.2006.03780.x.
- Literature searchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muiz A. Chaudhry, MD principal investigator
Ostfold Hospital Trust HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective colon resection in people with Colon Cancer and Benign Colon Diseases, run by Ostfold Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of microcirculation in colon wall and bowel anastomosis by laser induced fluorescence video angiography of indocyanine green (time frame: 2 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01419860, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.