Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT03948958
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2019-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PREMO Study: to Investigate Port REMoval Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D055499', 'term': 'Catheter-Related Infections'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001777', 'term': 'Blood Coagulation'}, {'id': 'D000071066', 'term': 'Patient Reported Outcome Measures'}, {'id': 'D057785', 'term': 'Catheters'}], 'ancestors': [{'id': 'D006487', 'term': 'Hemostasis'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D019538', 'term': 'Health Care Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D063868', 'term': 'Patient Outcome Assessment'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-13', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient-reported outcome measure', 'timeFrame': 'during the 1 day of TIVAD removal', 'description': "Patient's experiences will be collected by means of the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire a self-reported 25-items questionnaire"}], 'primaryOutcomes': [{'measure': 'TIVAD function', 'timeFrame': 'during the 1 day of TIVAD removal, before the linogram', 'description': 'will be assessed in terms of both injection and aspiration abilities. The ability is scored as easy, difficult or impossible along the Catheter Injection and Aspiration (CINAS) classification.'}], 'secondaryOutcomes': [{'measure': 'Catheter tip position visualization by fluoroscopy', 'timeFrame': 'during the 1 day of TIVAD removal, just before the linogram', 'description': 'The patient will be positioned in a nearly standing position with chest elevation of 17°'}, {'measure': 'Port chamber filling, sleeve formation, sleeve extend, catheter tip thrombosis and damage in port chamber or catheter trajectory', 'timeFrame': 'during the 1 day of TIVAD removal', 'description': 'will be visualised by linogram (digital substraction angiography)'}, {'measure': 'Catheter tip and port chamber culture', 'timeFrame': 'during the 1 day of TIVAD removal (following TIVAD removal)', 'description': 'microbial culture'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular Access Devices', 'Implantable port', 'Flush interval', 'Catheter function', 'Catheter-related infection', 'Catheter tip location', 'Catheter tip thrombus', 'Catheter sleeve', 'Patient-reported outcome measure'], 'conditions': ['Neoplasms', 'Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '23553060', 'type': 'BACKGROUND', 'citation': 'Goossens GA, Jerome M, Janssens C, Peetermans WE, Fieuws S, Moons P, Verschakelen J, Peerlinck K, Jacquemin M, Stas M. Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial. Ann Oncol. 2013 Jul;24(7):1892-1899. doi: 10.1093/annonc/mdt114. Epub 2013 Apr 3.'}, {'pmid': '23978939', 'type': 'BACKGROUND', 'citation': 'Odabas H, Ozdemir NY, Ziraman I, Aksoy S, Abali H, Oksuzoglu B, Isik M, Civelek B, Dede D, Zengin N. Effect of port-care frequency on venous port catheter-related complications in cancer patients. Int J Clin Oncol. 2014 Aug;19(4):761-6. doi: 10.1007/s10147-013-0609-7. Epub 2013 Aug 27.'}, {'pmid': '24100090', 'type': 'BACKGROUND', 'citation': 'Palese A, Baldassar D, Rupil A, Bonanni G, Capellari Maria T, Contessi D, De Crignis L, Vidoni A, Piller Roner S, Zanini A. Maintaining patency in totally implantable venous access devices (TIVAD): a time-to-event analysis of different lock irrigation intervals. Eur J Oncol Nurs. 2014 Feb;18(1):66-71. doi: 10.1016/j.ejon.2013.09.002. Epub 2013 Oct 4.'}, {'pmid': '28084883', 'type': 'BACKGROUND', 'citation': 'Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.'}, {'pmid': '19340795', 'type': 'BACKGROUND', 'citation': 'Dal Molin A, Guerretta L, Mazzufero F, Rasero L. The management of totally implanted venous ports in the ambulatory oncologic patient. J Vasc Access. 2009 Jan-Mar;10(1):22-6. doi: 10.1177/112972980901000104.'}, {'pmid': '26075094', 'type': 'BACKGROUND', 'citation': 'Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14.'}, {'pmid': '25404862', 'type': 'BACKGROUND', 'citation': 'Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014.'}, {'pmid': '8150521', 'type': 'BACKGROUND', 'citation': 'Gristina AG, Giridhar G, Gabriel BL, Naylor PT, Myrvik QN. Cell biology and molecular mechanisms in artificial device infections. Int J Artif Organs. 1993 Nov;16(11):755-63.'}, {'pmid': '10524963', 'type': 'BACKGROUND', 'citation': 'Douard MC, Arlet G, Longuet P, Troje C, Rouveau M, Ponscarme D, Eurin B. Diagnosis of venous access port-related infections. Clin Infect Dis. 1999 Nov;29(5):1197-202. doi: 10.1086/313444.'}, {'pmid': '16596525', 'type': 'BACKGROUND', 'citation': 'Brouns F, Schuermans A, Verhaegen J, De Wever I, Stas M. Infection assessment of totally implanted long-term venous access devices. J Vasc Access. 2006 Jan-Mar;7(1):24-8. doi: 10.1177/112972980600700105.'}, {'pmid': '25865922', 'type': 'BACKGROUND', 'citation': 'Tang S, Beigel R, Arsanjani R, Larson B, Luthringer D, Siegel R. Infective Endovascular Fibrin Sheath Vegetations-A New Cause of Bacteremia Detected by Transesophageal Echocardiogram. Am J Med. 2015 Sep;128(9):1029-38. doi: 10.1016/j.amjmed.2015.03.019. Epub 2015 Apr 10.'}, {'pmid': '21305467', 'type': 'BACKGROUND', 'citation': 'Onal B, Coskun B, Karabulut R, Ilgit ET, Turkyilmaz Z, Sonmez K. Interventional radiological retrieval of embolized vascular access device fragments. Diagn Interv Radiol. 2012 Jan-Feb;18(1):87-91. doi: 10.4261/1305-3825.DIR.4098-10.1. Epub 2011 Feb 8.'}, {'pmid': '27768210', 'type': 'BACKGROUND', 'citation': 'Kojima S, Hiraki T, Gobara H, Iguchi T, Fujiwara H, Matsui Y, Mitsuhashi T, Kanazawa S. Fracture of totally implanted central venous access devices: a propensity-score-matched comparison of risks for Groshong silicone versus polyurethane catheters. J Vasc Access. 2016 Nov 2;17(6):535-541. doi: 10.5301/jva.5000606. Epub 2016 Oct 21.'}, {'pmid': '26209949', 'type': 'BACKGROUND', 'citation': 'Goossens GA, De Waele Y, Jerome M, Fieuws S, Janssens C, Stas M, Moons P. Diagnostic accuracy of the Catheter Injection and Aspiration (CINAS) classification for assessing the function of totally implantable venous access devices. Support Care Cancer. 2016 Feb;24(2):755-761. doi: 10.1007/s00520-015-2839-x. Epub 2015 Jul 26.'}, {'pmid': '24316016', 'type': 'BACKGROUND', 'citation': 'Bouza E, Martin-Rabadan P, Echenagusia A, Camunez F, Rodriguez-Rosales G, Simo G, Echenagusia M, Guembe M; GEIDI study group. Diagnosis of venous access port colonization requires cultures from multiple sites: should guidelines be amended? Diagn Microbiol Infect Dis. 2014 Feb;78(2):162-7. doi: 10.1016/j.diagmicrobio.2013.11.004. Epub 2013 Nov 14.'}, {'pmid': '25799876', 'type': 'BACKGROUND', 'citation': 'Marcy PY, Dahlet C, Brenet O, Yazbec G, Dubois PY, Salm B, Fouche Y, Mari V, Montastruc M, Lebrec N, Ancel B, Paillocher N, Dupoiron D, Rangeard O, Michel C, Chateau Y, Ettaiche M, Ferrero JM, Chamorey E. [Multicenter validation study of a questionnaire assessing patient satisfaction with and acceptance of totally-implanted central venous access devices]. Bull Cancer. 2015 Apr;102(4):301-15. doi: 10.1016/j.bulcan.2015.02.012. Epub 2015 Mar 21. French.'}, {'pmid': '16596559', 'type': 'BACKGROUND', 'citation': 'Goossens GA, Vrebos M, De Wever I, Stas M. Vacutainer filling time through subcutaneous venous access devices. J Vasc Access. 2004 Oct-Dec;5(4):154-60. doi: 10.1177/112972980400500404.'}, {'pmid': '40421915', 'type': 'DERIVED', 'citation': "Goossens GA, Douchy T, Jerome M, Peeters Y, Hompes D, Boecxstaens V. Port REMoval Outcomes (PREMO) study: Patients' experiences with a Totally Implantable Venous Access Device: A questionnaire at device removal. J Vasc Access. 2025 May 27:11297298251340461. doi: 10.1177/11297298251340461. Online ahead of print."}, {'pmid': '40359084', 'type': 'DERIVED', 'citation': 'Douchy T, Hompes D, Maleux G, Jerome M, Peeters Y, Goossens GA, Boecxstaens V. Port REMoval Outcomes (PREMO) study: A pilot study for functional, microbial, radiological, and macroscopic assessment of totally implantable venous access devices. J Vasc Access. 2025 May 13:11297298251335416. doi: 10.1177/11297298251335416. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.', 'detailedDescription': "A Totally Implantable Venous Access Device (TIVAD) or so called implantable port that is no longer in use for intravenous therapy, should be removed or flushed at established intervals to promote and maintain patency. The maintenance procedure consists of a 10 ml 0.9% sodium chloride pulsatile flush. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. In het university hospitals Leuven the current interval is 3 months. Studies confirmed the safety and efficacy of an extended maintenance interval to once every 4 months. Many patients have relatively poor compliance with their regular port flushing procedure.\n\nClinicians tend to prolong the recommended interval or even to omit the maintenance procedure. Therefore in clinical practice, intervals vary widely among institutions. To the best of our knowledge, a comprehensive investigation of the risks related to catheter patency, bacterial colonization and catheter integrity, has never been performed in patients whose port is electively removed using a 3 months flushing maintenance regimen. To assess the impact of the maintenance interval, patients will be included in the study if the patient's TIVAD is not being used for regularly therapy for a total period of at least one year.\n\nThis exploratory study will focus on catheter function and colonisation, tip position and tip thrombosis, sleeve formation, removal problems and also patient experiences at elective planned TIVAD removal therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of 18 years and older, with a TIVAD that is no longer used for intravenous therapy on a regular basis for the past 365 days after completing initially planned treatment.\n* Patients planned for an elective TIVAD removal under local anaesthesia.\n* Patients able to participate in the study and willing to sign an informed consent.\n* Patients able to understand and read Dutch.\n\nExclusion Criteria:\n\n• History of fever and/or chills following last flushing procedure'}, 'identificationModule': {'nctId': 'NCT03948958', 'acronym': 'PREMO', 'briefTitle': 'PREMO Study: to Investigate Port REMoval Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Pilot Trial to Assess Functional, Microbial, Radiological and Patient Reported Outcomes at Totally Implantable Venous Access Device (Port) Removal (PREMO Study)', 'orgStudyIdInfo': {'id': 'S62321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIVAD evaluation', 'description': 'TIVAD evaluation at port removal evaluation of catheter function, visualization of catheter tip, presence of thrombus material and sleeve and any device damage during linogram (contrast injection via TIVAD), tip and chamber content microbiological culture, macroscopic catheter and port chamber evaluation PROM: patient reported outcome measurements regarding TIVAD insertion, presence and removal', 'interventionNames': ['Other: Evaluation of the catheter function', 'Other: Catheter tip location, thrombus, sleeve and device damage visualization', 'Other: Catheter-related colonization', 'Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD', 'Other: Macroscopic evaluation of the port chamber and catheter']}], 'interventions': [{'name': 'Evaluation of the catheter function', 'type': 'OTHER', 'description': 'Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)', 'armGroupLabels': ['TIVAD evaluation']}, {'name': 'Catheter tip location, thrombus, sleeve and device damage visualization', 'type': 'OTHER', 'description': 'Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram', 'armGroupLabels': ['TIVAD evaluation']}, {'name': 'Catheter-related colonization', 'type': 'OTHER', 'description': 'TIVAD colonization will be investigated by microbiological culture of the tip and chamber content', 'armGroupLabels': ['TIVAD evaluation']}, {'name': 'patient-reported outcome measures (PROM) related to the presence of the TIVAD', 'type': 'OTHER', 'description': "PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.", 'armGroupLabels': ['TIVAD evaluation']}, {'name': 'Macroscopic evaluation of the port chamber and catheter', 'type': 'OTHER', 'description': 'Macroscopic evaluation of the port chamber and catheter will be performed after port removal.', 'armGroupLabels': ['TIVAD evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Marguerite Stas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'B. Braun Medical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Stas Marguerite', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}