Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-21 @ 6:23 AM
Study NCT ID:
NCT02741167
Status:
UNKNOWN
Last Update Posted:
2017-05-04
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010534', 'term': 'Peritoneal Neoplasms'}], 'ancestors': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084262', 'term': 'Hyperthermic Intraperitoneal Chemotherapy'}], 'ancestors': [{'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2016-03-30', 'studyFirstSubmitQcDate': '2016-04-12', 'lastUpdatePostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C reactive protein (CRP) mg/l, receiver operating characteristic (ROC)', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peritoneal surface malignancies', 'cytoreductive surgery', 'hyperthermic intraperitoneal chemotherapy'], 'conditions': ['Peritoneal Cancer']}, 'referencesModule': {'references': [{'pmid': '19474692', 'type': 'BACKGROUND', 'citation': 'Chua TC, Yan TD, Saxena A, Morris DL. Should the treatment of peritoneal carcinomatosis by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy still be regarded as a highly morbid procedure?: a systematic review of morbidity and mortality. Ann Surg. 2009 Jun;249(6):900-7. doi: 10.1097/SLA.0b013e3181a45d86.'}, {'pmid': '20888755', 'type': 'BACKGROUND', 'citation': 'Roviello F, Caruso S, Marrelli D, Pedrazzani C, Neri A, De Stefano A, Pinto E. Treatment of peritoneal carcinomatosis with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: state of the art and future developments. Surg Oncol. 2011 Mar;20(1):e38-54. doi: 10.1016/j.suronc.2010.09.002. Epub 2010 Dec 15.'}, {'pmid': '25793700', 'type': 'BACKGROUND', 'citation': 'Klein HJ, Csordas A, Falk V, Slankamenac K, Rudiger A, Schonrath F, Rodriguez Cetina Biefer H, Starck CT, Graf R. Pancreatic stone protein predicts postoperative infection in cardiac surgery patients irrespective of cardiopulmonary bypass or surgical technique. PLoS One. 2015 Mar 20;10(3):e0120276. doi: 10.1371/journal.pone.0120276. eCollection 2015.'}, {'pmid': '18726887', 'type': 'BACKGROUND', 'citation': 'Younan R, Kusamura S, Baratti D, Cloutier AS, Deraco M. Morbidity, toxicity, and mortality classification systems in the local regional treatment of peritoneal surface malignancy. J Surg Oncol. 2008 Sep 15;98(4):253-7. doi: 10.1002/jso.21057.'}, {'pmid': '22480844', 'type': 'BACKGROUND', 'citation': 'Votanopoulos K, Ihemelandu C, Shen P, Stewart J, Russell G, Levine EA. A comparison of hematologic toxicity profiles after heated intraperitoneal chemotherapy with oxaliplatin and mitomycin C. J Surg Res. 2013 Jan;179(1):e133-9. doi: 10.1016/j.jss.2012.01.015. Epub 2012 Mar 10.'}, {'pmid': '25131719', 'type': 'BACKGROUND', 'citation': 'Sonnenberg EM, Reinke CE, Bartlett EK, Collier KT, Karakousis GC, Holena DN, Kelz RR. Wind, water, wound, walk--do the data deliver the dictum? J Surg Educ. 2015 Jan-Feb;72(1):164-9. doi: 10.1016/j.jsurg.2014.05.019. Epub 2014 Aug 12.'}, {'pmid': '26669784', 'type': 'RESULT', 'citation': 'Lehmann K, Eshmuminov D, Slankamenac K, Kranzbuhler B, Clavien PA, Vonlanthen R, Gertsch P. Where Oncologic and Surgical Complication Scoring Systems Collide: Time for a New Consensus for CRS/HIPEC. World J Surg. 2016 May;40(5):1075-81. doi: 10.1007/s00268-015-3366-0.'}, {'pmid': '17708508', 'type': 'RESULT', 'citation': 'Capone A, Valle M, Proietti F, Federici O, Garofalo A, Petrosillo N. Postoperative infections in cytoreductive surgery with hyperthermic intraperitoneal intraoperative chemotherapy for peritoneal carcinomatosis. J Surg Oncol. 2007 Nov 1;96(6):507-13. doi: 10.1002/jso.20837.'}, {'pmid': '30954352', 'type': 'DERIVED', 'citation': 'Roth L, Eshmuminov D, Laminger F, Koppitsch C, Schneider M, Graf TR, Gupta A, Kober F, Roka S, Gertsch P, Lehmann K. Systemic inflammatory response after hyperthermic intraperitoneal chemotherapy (HIPEC): The perfusion protocol matters! Eur J Surg Oncol. 2019 Sep;45(9):1734-1739. doi: 10.1016/j.ejso.2019.03.036. Epub 2019 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the dynamics of inflammatory parameters in presence or absence of infectious complications after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.', 'detailedDescription': 'Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy is the treatment of choice in patients with primary or secondary peritoneal surface malignancies. However the survival benefit is achieved at the cost of increased morbidity and mortality due to an extensive surgery and intraoperative chemo-therapy. Among complications infectious complications are the most common. The early diagnosis of a potential fatal infection is therefore crucial to ensure a good outcome in patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive adult patients (more than 18 years) subjected to cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) due to peritoneal malignancy at our institution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive adult patients (more than 18 years) subjected to CRS and HIPEC due to peritoneal malignancy.\n* Written informed consent by the participant after information about the research project\n\nExclusion Criteria:\n\n* No primary or secondary peritoneal surface malignancy\n* No CRS and HIPEC\n* Pregnancy\n* Younger than 18 years'}, 'identificationModule': {'nctId': 'NCT02741167', 'briefTitle': 'Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy', 'orgStudyIdInfo': {'id': 'HIPEC 2015-0529'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRS and HIPEC', 'description': 'Patients subjected to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) due to primary or secondary peritoneal malignancy', 'interventionNames': ['Procedure: CRS and HIPEC']}], 'interventions': [{'name': 'CRS and HIPEC', 'type': 'PROCEDURE', 'description': 'During CRS, all visible peritoneal tumors are removed. Consequently micrometastasis are removed with hyperthermic intraperitoneal chemotherapy', 'armGroupLabels': ['CRS and HIPEC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Kuno Lehmann, MD, PhD', 'role': 'CONTACT', 'email': 'kuno.lehmann@usz.ch', 'phone': '+41 44 255 23 04'}, {'name': 'Dilmurodjon Eshmuminov, MD', 'role': 'CONTACT', 'email': 'dilmurodjon.eshmuminov@usz.ch', 'phone': '+41 44 255 11 11'}], 'facility': 'Division of Visceral Surgery and Transplantation , University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Kuno Lehmann, MD, PhD', 'role': 'CONTACT', 'email': 'kuno.lehmann@usz.ch', 'phone': '+41 44 255 23 04'}, {'name': 'Dilmurodjon Eshmuminov, MD', 'role': 'CONTACT', 'email': 'dilmurodjon.eshmuminov@usz.ch', 'phone': '+41 44 255 11 11'}], 'overallOfficials': [{'name': 'Kuno Lehmann, Md. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Kuno Lehmann, Division of Visceral Surgery and Transplantation, University Hospital Zurich, Ramistrasse 100, 8091 Zurich, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}