Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT03559894
Status:
UNKNOWN
Last Update Posted:
2018-06-18
First Post:
2017-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe and Transient Hypoxemia During Selective Intra-arterial Chemotherapy for Retinoblastoma in Children: Evaluation of the Right-sided Heart Function.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012175', 'term': 'Retinoblastoma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D019572', 'term': 'Retinal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of pulmonary hypertension and/or right-sided heart failure (systolic arterial pulmonary pressure and visual function of the right ventricle is measured)', 'timeFrame': 'Perioperative.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinoblastoma']}, 'referencesModule': {'references': [{'pmid': '23668238', 'type': 'RESULT', 'citation': 'Phillips TJ, McGuirk SP, Chahal HK, Kingston J, Robertson F, Brew S, Roebuck D, Hungerford JL, Herod J. Autonomic cardio-respiratory reflex reactions and superselective ophthalmic arterial chemotherapy for retinoblastoma. Paediatr Anaesth. 2013 Oct;23(10):940-5. doi: 10.1111/pan.12162. Epub 2013 May 13.'}, {'pmid': '25565164', 'type': 'RESULT', 'citation': "Kato MA, Green N, O'Connell K, Till SD, Kramer DJ, Al-Khelaifi M, Han JH, Pryor KO, Gobin YP, Proekt A. A retrospective analysis of severe intraoperative respiratory compliance changes during ophthalmic arterial chemosurgery for retinoblastoma. Paediatr Anaesth. 2015 Jun;25(6):595-602. doi: 10.1111/pan.12603. Epub 2015 Jan 7."}, {'pmid': '27748655', 'type': 'RESULT', 'citation': 'Scharoun JH, Han JH, Gobin YP. Anesthesia for Ophthalmic Artery Chemosurgery. Anesthesiology. 2017 Jan;126(1):165-172. doi: 10.1097/ALN.0000000000001381. No abstract available.'}, {'pmid': '25325870', 'type': 'RESULT', 'citation': 'Monroy JE, Orbach DB, VanderVeen D. Complications of intra-arterial chemotherapy for retinoblastoma. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):429-33. doi: 10.3109/08820538.2014.959188.'}, {'pmid': '19542994', 'type': 'RESULT', 'citation': 'Schaller B, Cornelius JF, Prabhakar H, Koerbel A, Gnanalingham K, Sandu N, Ottaviani G, Filis A, Buchfelder M; Trigemino-Cardiac Reflex Examination Group (TCREG). The trigemino-cardiac reflex: an update of the current knowledge. J Neurosurg Anesthesiol. 2009 Jul;21(3):187-95. doi: 10.1097/ANA.0b013e3181a2bf22.'}]}, 'descriptionModule': {'briefSummary': 'Children having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia may experience troubles during the procedure. The troubles are transient, may be severe and include hypoxemia, hypotension and bradycardia. All children having such trouble always fully recovered without any sequelae or prolonged length of stay. The investigators suspect that these phenomenons are caused by transient pulmonary hypertension.The objective is to see whether transient pulmonary hypertension and right-sided heart failure is present during theses phenomenon by trans-thoracic echocardiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All children 0 to 6 years old having selective ophthalmic artery chemotherapy for retinoblastoma under general anaesthesia are eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Retinoblastoma requiring selective ophthalmic artery chemotherapy under general anaesthesia\n\nExclusion Criteria:\n\n* Obesity\n* pre-existing significant heart or pulmonary disease.'}, 'identificationModule': {'nctId': 'NCT03559894', 'briefTitle': 'Severe and Transient Hypoxemia During Selective Intra-arterial Chemotherapy for Retinoblastoma in Children: Evaluation of the Right-sided Heart Function.', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Severe and Transient Hypoxemia During Selective Intra-arterial Chemotherapy for Retinoblastoma in Children: Evaluation of the Right-sided Heart Function.', 'orgStudyIdInfo': {'id': '2017-01539'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Trans-thoracic echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Trans-thoracic echocardiography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christian Kern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christian Kern', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}