Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-02-19 @ 11:37 AM
Study NCT ID:
NCT04712032
Status:
UNKNOWN
Last Update Posted:
2021-01-15
First Post:
2021-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D003424', 'term': 'Crohn Disease'}], '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'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Intraoperative imaging is unable to blind the surgeon. Patient is only blinded preoperatively.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'National randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 978}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-days Anastomotic Leakage (AL) rate', 'timeFrame': '90 days', 'description': 'Anastomotic leakage rate'}], 'secondaryOutcomes': [{'measure': '30-days Anastomotic Leakage ( AL) rate', 'timeFrame': '30 days', 'description': 'Anastomotic leakage rate'}, {'measure': 'complication rate', 'timeFrame': '90 days'}, {'measure': 'mortality', 'timeFrame': '90 days'}, {'measure': 'days in hospital stay', 'timeFrame': '90 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colo-rectal Cancer', 'Crohn Disease', 'Resectable Colorectal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '39151436', 'type': 'DERIVED', 'citation': 'Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.'}, {'pmid': '35365509', 'type': 'DERIVED', 'citation': 'Meijer RPJ, Faber RA, Bijlstra OD, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Mieog JSD, Burggraaf K, Vahrmeijer AL, Hilling DE; AVOID study group. AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery. BMJ Open. 2022 Apr 1;12(4):e051144. doi: 10.1136/bmjopen-2021-051144.'}]}, 'descriptionModule': {'briefSummary': 'Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;\n2. Patients aged over 18 years old;\n3. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;\n4. Signed informed consent prior to any study-mandated procedure;\n\nExclusion Criteria:\n\n1. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;\n2. Severe liver or kidney insufficiency;\n3. Hyperthyroidism or a benign thyroid tumour;\n4. Pregnant or breastfeeding women;\n5. Scheduled for palliative surgery or terminal ill\n6. Scheduled for a diverting stoma\n7. Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination;\n8. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;\n9. Emergency surgery'}, 'identificationModule': {'nctId': 'NCT04712032', 'acronym': 'AVOID', 'briefTitle': 'Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES', 'orgStudyIdInfo': {'id': 'P19.079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Image Guided Bowel Anastomosis group', 'description': 'ICG-guided perfusion assessment', 'interventionNames': ['Drug: ICG-guided bowel perfusion assessment']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional Bowel Anastomosis group', 'description': 'conventional perfusion assessment'}], 'interventions': [{'name': 'ICG-guided bowel perfusion assessment', 'type': 'DRUG', 'description': 'ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.', 'armGroupLabels': ['Image Guided Bowel Anastomosis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 ZA', 'city': 'Leiden', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ruben Meijer, MD', 'role': 'CONTACT', 'email': 'r.p.j.meijer@lumc.nl', 'phone': '+31 71 526 9111'}, {'name': 'Robin Faber', 'role': 'CONTACT', 'email': 'r.a.faber@lumc.nl'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'centralContacts': [{'name': 'Alexander Vahrmeijer, MD, PhD', 'role': 'CONTACT', 'email': 'a.l.vahrmeijer@lumc.nl', 'phone': '071 526 9111'}, {'name': 'Ruben Meijer, MD', 'role': 'CONTACT', 'email': 'r.p.j.meijer@lumc.nl', 'phone': '071 526 9111'}], 'overallOfficials': [{'name': 'Alexander Vahrmeijer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LUMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Center Haaglanden', 'class': 'OTHER'}, {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, {'name': 'Haga Hospital', 'class': 'OTHER'}, {'name': 'Jeroen Bosch Ziekenhuis', 'class': 'OTHER'}, {'name': 'Amphia Hospital', 'class': 'OTHER'}, {'name': 'Alrijne Hospital', 'class': 'OTHER'}, {'name': 'IJsselland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexander Vahrmeijer', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}