Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT04225494
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2019-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'targetDuration': '4 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-02', 'studyFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Cortisol peak after low dose Synachten stimulation test.', 'timeFrame': '1st postoperative day', 'description': 'Assessment of early postoperative acute adrenal dysfunction.'}, {'measure': 'Serum Cortisol peak after low dose Synachten stimulation test.', 'timeFrame': '10th postoperative day', 'description': 'Assessment of postoperative acute adrenal dysfunction.'}, {'measure': 'Serum Cortisol peak after low dose Synachten stimulation test.', 'timeFrame': '4 months after surgery (only if test positive on 10th postoperative day)', 'description': 'Assessment of postoperative chronic adrenal dysfunction.'}], 'secondaryOutcomes': [{'measure': 'Postoperative morbidity', 'timeFrame': '30th postoperative day', 'description': 'Correlation between morbidity according to Clavien-Dindo and postoperative adrenal dysfunction'}, {'measure': 'Vasoactive inotropic score', 'timeFrame': 'Intraoperatively and up to 3rd postoperative day', 'description': 'Correlation between intra- and postoperative usage of vasoactive drugs and postoperative adrenal dysfunction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retroperitoneal Sarcoma', 'Surgery', 'Haemodynamic assessment', 'Adrenalectomy'], 'conditions': ['Adrenal; Functional Disturbance', 'Retroperitoneal Sarcoma', 'Intraoperative Hypotension']}, 'referencesModule': {'references': [{'pmid': '30285214', 'type': 'BACKGROUND', 'citation': 'Casali PG, Abecassis N, Aro HT, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Brodowicz T, Broto JM, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dileo P, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kasper B, Kopeckova K, Krakorova DA, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schoffski P, Sleijfer S, Stacchiotti S, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee and EURACAN. Soft tissue and visceral sarcomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv268-iv269. doi: 10.1093/annonc/mdy321. No abstract available.'}, {'pmid': '29846498', 'type': 'BACKGROUND', 'citation': 'Casali PG, Abecassis N, Aro HT, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Brodowicz T, Broto JM, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dileo P, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kasper B, Kopeckova K, Krakorova DA, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schoffski P, Sleijfer S, Stacchiotti S, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee and EURACAN. Soft tissue and visceral sarcomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv51-iv67. doi: 10.1093/annonc/mdy096. No abstract available.'}, {'pmid': '28437313', 'type': 'BACKGROUND', 'citation': 'Visioni A, Shah R, Gabriel E, Attwood K, Kukar M, Nurkin S. Enhanced Recovery After Surgery for Noncolorectal Surgery?: A Systematic Review and Meta-analysis of Major Abdominal Surgery. Ann Surg. 2018 Jan;267(1):57-65. doi: 10.1097/SLA.0000000000002267.'}, {'pmid': '25316486', 'type': 'BACKGROUND', 'citation': 'Trans-Atlantic RPS Working Group. Management of primary retroperitoneal sarcoma (RPS) in the adult: a consensus approach from the Trans-Atlantic RPS Working Group. Ann Surg Oncol. 2015 Jan;22(1):256-63. doi: 10.1245/s10434-014-3965-2. Epub 2014 Oct 15.'}, {'pmid': '23324883', 'type': 'BACKGROUND', 'citation': 'Burry L, Little A, Hallett D, Mehta S. Detection of critical illness-related corticosteroid insufficiency using 1 mug adrenocorticotropic hormone test. Shock. 2013 Feb;39(2):144-8. doi: 10.1097/SHK.0b013e31827daf0b.'}, {'pmid': '28938253', 'type': 'BACKGROUND', 'citation': 'Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers SC, Russell JA, Van den Berghe G. Guidelines for the Diagnosis and Management of Critical Illness-Related Corticosteroid Insufficiency (CIRCI) in Critically Ill Patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Crit Care Med. 2017 Dec;45(12):2078-2088. doi: 10.1097/CCM.0000000000002737.'}]}, 'descriptionModule': {'briefSummary': 'Early recognition of adrenal function deficit in patients undergoing multivisceral surgery including adrenalectomy for primitive retroperitoneal sarcomas', 'detailedDescription': 'The extended multivisceral resection of retroperitoneum is the standard treatment for primary retroperitoneal soft tissue sarcomas. This procedure also includes the removal of the healthy adrenal gland ipsilateral to the tumor site.\n\nThe investigators think that a such extended surgical approach together with the removal of the adrenal gland may lead to a state of acute adrenal insufficiency and related hemodynamic instability.\n\nIn order to recognize this condition the investigators use a low dose ACTH test (Synacthen test) during the 1° and 10° post-operative days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary retroperitoneal sarcoma candidated to extended multivisceral resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age\\> 18 years)\n* Diagnosis of retroperitoneal sarcoma\n* Adrenalectomy enbloc included in multivisceral resection\n* Voluntary informed written consent\n\nExclusion Criteria:\n\n* Recurrent and / or metastatic disease\n* Patient chronically treated with corticosteroids\n* Primary disorders of adrenal gland\n* Basal serum cortisol values ≤ 7 µg / dL\n* Clinically significant heart disease\n* Altered TSH'}, 'identificationModule': {'nctId': 'NCT04225494', 'acronym': 'RAF', 'briefTitle': 'Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}, 'officialTitle': 'Evaluation of Perioperative Residual Adrenal Function After Extended Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study', 'orgStudyIdInfo': {'id': '64/19'}}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Five years after study complexion', 'ipdSharing': 'YES', 'description': 'Individual Participant Data will be shared upon request.', 'accessCriteria': 'Upon motivated request to PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marco Fiore', 'investigatorAffiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}}}}