Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-31 @ 4:10 PM
Study NCT ID:
NCT01419860
Status:
COMPLETED
Last Update Posted:
2022-05-02
First Post:
2011-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2011-06-30', 'studyFirstSubmitQcDate': '2011-08-17', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of microcirculation in colon wall and bowel anastomosis by laser induced fluorescence video angiography of indocyanine green', 'timeFrame': '2 min', '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.'}], 'secondaryOutcomes': [{'measure': 'Predicting perfusion deficit with laser-induced ICG fluorescence video angiography', 'timeFrame': '2 min', 'description': 'New method for predicting perfusion deficits and peroperative guide the surgeon in decision to recreate a new anastomosis or stoma.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Microcirculation', 'Colon', 'Anastomosis', 'ICG', 'Gastro surgery', 'benign colon diseases requiring resection'], 'conditions': ['Colon Cancer', 'Benign Colon Diseases']}, 'referencesModule': {'references': [{'pmid': '5621502', 'type': 'BACKGROUND', 'citation': 'Marston A. Vascular disorders of the colon. Acta Chir Belg. 1967 Dec 2;Suppl 2:80-92. No abstract available.'}, {'pmid': '17653567', 'type': 'BACKGROUND', 'citation': 'Massacesi 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.'}, {'pmid': '14563675', 'type': 'BACKGROUND', 'citation': 'Ba 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.'}, {'pmid': '19423513', 'type': 'BACKGROUND', 'citation': 'Handa 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.'}, {'pmid': '19306390', 'type': 'BACKGROUND', 'citation': 'Holm 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.'}, {'pmid': '18377242', 'type': 'BACKGROUND', 'citation': 'Pena-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.'}, {'pmid': '19847873', 'type': 'BACKGROUND', 'citation': 'Murawa 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.'}, {'pmid': '15494283', 'type': 'RESULT', 'citation': 'Chambers 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.'}, {'pmid': '11910487', 'type': 'RESULT', 'citation': 'Alves 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.'}, {'pmid': '18034250', 'type': 'RESULT', 'citation': 'Buchs 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.'}, {'pmid': '12436148', 'type': 'RESULT', 'citation': 'Lustosa 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.'}, {'pmid': '16813622', 'type': 'RESULT', 'citation': 'Lipska 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.'}, {'pmid': '6186177', 'type': 'RESULT', 'citation': 'Leaper 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.'}, {'pmid': '12550116', 'type': 'RESULT', 'citation': 'Holm 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.'}, {'pmid': '942422', 'type': 'RESULT', 'citation': 'Muckle 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.'}, {'pmid': '18198412', 'type': 'RESULT', 'citation': 'Prantl L, Schmitt S, Geis S, Tsui TY, Lamby P, Nerlich M, Kubale R, Zorger N, Herold T, Feuerbach S, Jung EM. Contrast harmonic ultrasound and indocyanine-green fluorescence video angiography for evaluation of dermal and subdermal microcirculation in free parascapular flaps. Clin Hemorheol Microcirc. 2008;38(2):105-18.'}, {'pmid': '18503134', 'type': 'RESULT', 'citation': 'Lamby P, Prantl L, Gais S, Walter M, Bachthaler M, Nerlich M, Feuerbach S, Jung EM. Evaluation of the vascular integrity of free flaps based on microcirculation imaging techniques. Clin Hemorheol Microcirc. 2008;39(1-4):253-63.'}, {'pmid': '18836805', 'type': 'RESULT', 'citation': 'Mitsuhashi N, Kimura F, Shimizu H, Imamaki M, Yoshidome H, Ohtsuka M, Kato A, Yoshitomi H, Nozawa S, Furukawa K, Takeuchi D, Takayashiki T, Suda K, Igarashi T, Miyazaki M. Usefulness of intraoperative fluorescence imaging to evaluate local anatomy in hepatobiliary surgery. J Hepatobiliary Pancreat Surg. 2008;15(5):508-14. doi: 10.1007/s00534-007-1307-5. Epub 2008 Oct 4.'}, {'pmid': '16926320', 'type': 'RESULT', 'citation': 'Thoeni RF, Cello JP. CT imaging of colitis. Radiology. 2006 Sep;240(3):623-38. doi: 10.1148/radiol.2403050818.'}, {'pmid': '18976973', 'type': 'RESULT', 'citation': 'Krasniqi A, Gashi-Luci L, Krasniqi S, Jakupi M, Hashani Sh, Limani D, Dreshaj IA. A comparison of three single layer anastomotic techniques in the colon of the rat. Int J Surg. 2009 Feb;7(1):31-5. doi: 10.1016/j.ijsu.2008.10.005. Epub 2008 Oct 18.'}, {'pmid': '8476155', 'type': 'RESULT', 'citation': 'Ceraldi CM, Rypins EB, Monahan M, Chang B, Sarfeh IJ. Comparison of continuous single layer polypropylene anastomosis with double layer and stapled anastomoses in elective colon resections. Am Surg. 1993 Mar;59(3):168-71.'}, {'pmid': '16422163', 'type': 'RESULT', 'citation': 'Siegel MP, Kim YL, Roy HK, Wali RK, Backman V. Assessment of blood supply in superficial tissue by polarization-gated elastic light-scattering spectroscopy. Appl Opt. 2006 Jan 10;45(2):335-42. doi: 10.1364/ao.45.000335.'}, {'pmid': '7977601', 'type': 'RESULT', 'citation': 'Obana A, Miki T, Hayashi K, Takeda M, Kawamura A, Mutoh T, Harino S, Fukushima I, Komatsu H, Takaku Y, et al. Survey of complications of indocyanine green angiography in Japan. Am J Ophthalmol. 1994 Dec 15;118(6):749-53. doi: 10.1016/s0002-9394(14)72554-1.'}], 'seeAlsoLinks': [{'url': 'http://pubmed.gov', 'label': 'Literature search'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMicrocirculation 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with colon cancer requiring elective surgical operation.\n\nExclusion Criteria:\n\n* Pregnancy\n* Children or patients below the age of 18 years\n* Advanced renal or hepatic failure\n* Previous allergic reactions to ICG and iodide\n* Chronic anemia\n* Active haematologic disease\n* Women of fertile age needed a negative pregnancy test to be included\n* Patients with previous colectomy or anorectal surgery were also excluded due to anatomical insult on mesenterial circulation'}, 'identificationModule': {'nctId': 'NCT01419860', 'briefTitle': 'Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Ostfold Hospital Trust'}, 'officialTitle': 'Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography of Indocyanine Green', 'orgStudyIdInfo': {'id': 'Microcirculation of colon'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pixel intensity', 'description': 'Pixel intensity of fluorescence signal describing pixel microcirculation of colon', 'interventionNames': ['Procedure: Elective colon resection']}], 'interventions': [{'name': 'Elective colon resection', 'type': 'PROCEDURE', 'otherNames': ['Surgical colon operations', 'Right sided hemicolectomy', 'Left sided hemicolectomy', 'Sigmoideum resection', 'Subtotal colon resection'], '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.', 'armGroupLabels': ['Pixel intensity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1603', 'city': 'Fredrikstad', 'state': 'Østfold fylke', 'country': 'Norway', 'facility': 'Østfold Hospital Trust HF', 'geoPoint': {'lat': 59.2181, 'lon': 10.9298}}], 'overallOfficials': [{'name': 'Muiz A. Chaudhry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ostfold Hospital Trust HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ostfold Hospital Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}