Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT02459405
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2015-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-02', 'studyFirstSubmitDate': '2015-04-04', 'studyFirstSubmitQcDate': '2015-05-28', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic leak rate', 'timeFrame': 'first 30 days', 'description': 'anastomotic leak rate at 30 post operative days'}], 'secondaryOutcomes': [{'measure': 'Time to perform the near infrared procedure', 'timeFrame': 'during surgery', 'description': 'measured added time to the procedure'}, {'measure': 'Time to get a near infrared signal', 'timeFrame': 'during surgery', 'description': 'Time to see a signal during surgery'}, {'measure': 'complication rate', 'timeFrame': '30 days', 'description': 'according to Clavien Dindo classification'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': '30 days mortality'}, {'measure': 'Alteration of the course of surgery due to insufficient vascularisation', 'timeFrame': 'during surgery', 'description': 'If the vascularisation is insufficient during the surgery, the investigators can change the course of the surgery he is performing. For example, it could lead to a second resection to obtain well vascularized tissue for the anastomosis. Any alteration of the regular course of surgery for the safety of the patient is reported. The number of patient requiring an alteration of the course of surgery will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal surgery', 'Near infrared', 'Indocyanine green', 'anastomotic leak', 'Prevention of leak'], 'conditions': ['Anastomotic Leak']}, 'referencesModule': {'references': [{'pmid': '24566744', 'type': 'BACKGROUND', 'citation': 'Ris F, Hompes R, Cunningham C, Lindsey I, Guy R, Jones O, George B, Cahill RA, Mortensen NJ. Near-infrared (NIR) perfusion angiography in minimally invasive colorectal surgery. Surg Endosc. 2014 Jul;28(7):2221-6. doi: 10.1007/s00464-014-3432-y. Epub 2014 Feb 25.'}, {'pmid': '22098511', 'type': 'BACKGROUND', 'citation': 'Cahill RA, Ris F, Mortensen NJ. Near-infrared laparoscopy for real-time intra-operative arterial and lymphatic perfusion imaging. Colorectal Dis. 2011 Nov;13 Suppl 7:12-7. doi: 10.1111/j.1463-1318.2011.02772.x.'}, {'pmid': '29663330', 'type': 'DERIVED', 'citation': 'Ris F, Liot E, Buchs NC, Kraus R, Ismael G, Belfontali V, Douissard J, Cunningham C, Lindsey I, Guy R, Jones O, George B, Morel P, Mortensen NJ, Hompes R, Cahill RA; Near-Infrared Anastomotic Perfusion Assessment Network VOIR. Multicentre phase II trial of near-infrared imaging in elective colorectal surgery. Br J Surg. 2018 Sep;105(10):1359-1367. doi: 10.1002/bjs.10844. Epub 2018 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread means of assessing the viability of a laparoscopic anastomosis. The investigators described recently the feasibility of microvascularisation assessment with near-infra red technology (NIR).\n\nThe aim of this study is to look at the implementation of this technique in a wider prospective series of patients undergoing colorectal resection.', 'detailedDescription': 'Multicentric prospective study of 260 consecutive patients undergoing colonic resection and being assessed during the course of surgery for microvascularisation.\n\nAfter vessel division and after colorectal anastomosis, indocyanine green (2.5mg/ml) is injected intravenously and anastomotic microvascularisation assessed with the PinPoint NIR system (Novadaq, Vancouver, Canada).\n\nStudy primary endpoint is the anastomotic leak rate Secondary endpoint are peroperative and post-operative complications according to the Clavien Dindo scale, time of the procedure and time to record a signal as well as any change of the procedure.\n\nThis study will be performed on 3 different sites Geneva, Oxford and Dublin University Hospitals'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Participant willing and able to comply with the study procedures.\n* Diagnosed with required colon or rectal neoplasia requiring surgical excision by either laparoscopic or open surgery.\n* A negative pregnancy test for women of childbearing potential prior to surgery\n* Able (in the Investigators opinion) and willing to comply with all study requirements\n\nExclusion Criteria:\n\n* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.\n* Allergy to Indocyanine green.\n* Participant who is undergoing purely palliative surgery or who is terminally ill\n* Subject has other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT02459405', 'briefTitle': 'Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging: a Multicentric Prospective Phase II Study', 'orgStudyIdInfo': {'id': '10/H0724/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIR anastomotic perfusion assessment', 'description': 'Patient will have their anastomosis assessed after they receive 7.5 to 9 mg of Indocyanine green intravenously (at a concentration of 2.5mg/ml).\n\nThe microvascularisation assessment will be performed using a near infrared device(Pinpoint device), allowing to increase reality.\n\nThis procedure will be repeated twice during the surgery, the first time before and the second time after the anastomosis has been done.', 'interventionNames': ['Procedure: NIR anastomotic perfusion assessment', 'Device: Near infrared camera']}], 'interventions': [{'name': 'NIR anastomotic perfusion assessment', 'type': 'PROCEDURE', 'otherNames': ['Indocyanine assessment of anastomotic microvascularisation'], 'description': 'Patient will have their anastomosis assessed by near infrared technology after indocyanine green has been injected i.v. The procedure will be repeated twice, once before the anastomosis and the second time after the anastomosis has been performed.', 'armGroupLabels': ['NIR anastomotic perfusion assessment']}, {'name': 'Near infrared camera', 'type': 'DEVICE', 'otherNames': ['Pinpoint evaluation'], 'description': 'Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green', 'armGroupLabels': ['NIR anastomotic perfusion assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Dublin University College, department of colorectal surgery', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Milan', 'state': 'Rozzano (Milano)', 'country': 'Italy', 'facility': 'Humanitas Universtity Hospitals', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '1224', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospitals, Service of Visceral Surgery', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'OX3', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals, Department of colorectal Surgery', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Frederic Ris, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'University College Dublin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PD', 'investigatorFullName': 'Ris Frederic', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}