{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T18:54:35Z","timestamp":1793386475480,"version":"4.5.0"},"reference-count":13,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2022,3,8]],"date-time":"2022-03-08T00:00:00Z","timestamp":1646697600000},"content-version":"unspecified","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100008276","name":"Skibsreder Per Henriksen, R. og hustrus fond","doi-asserted-by":"publisher","award":["300000 DKK"],"award-info":[{"award-number":["300000 DKK"]}],"id":[{"id":"10.13039\/501100008276","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009708","name":"Novo Nordisk Fonden","doi-asserted-by":"publisher","award":["2877084 DKK"],"award-info":[{"award-number":["2877084 DKK"]}],"id":[{"id":"10.13039\/501100009708","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,2,11]]},"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Pleural empyema is a frequent disease with a high morbidity and mortality. Current standard treatment includes antibiotics and thoracic ultrasound (TUS)-guided pigtail drainage. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of video-assisted thoracoscopic surgery (VATS) as first-line treatment. The aim of this study is to determine the difference in outcome in patients diagnosed with complex parapneumonic effusion (stage II) and pleural empyema (stage III) who are treated with either VATS surgery or TUS-guided drainage and intrapleural therapy (fibrinolytic (Alteplase) with DNase (Pulmozyme)) as first-line treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A national, multicentre randomised, controlled study. Totally, 184 patients with a newly diagnosed community acquired complicated parapneumonic effusion or pleural empyema are randomised to either (1) VATS procedure with drainage or (2) TUS-guided pigtail catheter placement and intrapleural therapy with Actilyse and DNase. The total follow-up period is 12 months. The primary endpoint is length of hospital stay and secondary endpoints include for example, mortality, need for additional interventions, consumption of analgesia and quality of life.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>\n                      All patients provide informed consent before randomisation. The research project is carried out in accordance with the Helsinki II Declaration, European regulations and Good Clinical Practice Guidelines. The Scientific Ethics Committees for Denmark and the Danish Data Protection Agency have provided permission. Information about the subjects is protected under the Personal Data Processing Act and the Health Act. The trial is registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"www.clinicaltrials.gov\">www.clinicaltrials.gov<\/jats:ext-link>\n                      , and monitored by the regional Good clinical practice monitoring unit. The results of this study will be published in peer-reviewed journals and presented at various national and international conferences.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04095676\">NCT04095676<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-054236","type":"journal-article","created":{"date-parts":[[2022,3,9]],"date-time":"2022-03-09T11:24:25Z","timestamp":1646825065000},"page":"e054236","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial \u2013 surgery as first-line treatment"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04095676","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6509-8510","authenticated-orcid":false,"given":"Thomas Decker","family":"Christensen","sequence":"first","affiliation":[{"name":"Department of Cardiothoracic and Vascular Surgery & Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morten","family":"Bendixen","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00f8ren Helbo","family":"Skaarup","sequence":"additional","affiliation":[{"name":"Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens-Ulrik","family":"Jensen","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, Copenhagen, Denmark"},{"name":"Institute for Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rene Horsleben","family":"Petersen","sequence":"additional","affiliation":[{"name":"Institute for Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merete","family":"Christensen","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Licht","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirsten","family":"Neckelmann","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo Martin","family":"Bibby","sequence":"additional","affiliation":[{"name":"Department of Public Health, Section for Biostatistics, Aarhus University, Aarhus, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars B","family":"M\u00f8ller","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Aalborg University Hospital, Aalborg, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1231-9209","authenticated-orcid":false,"given":"Uffe","family":"Bodtger","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine & Department of Respiratory Medicine, Zealand University Hospital, Naestved-Slagelse Hospital, Naestved, Denmark"},{"name":"Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morten Hornemann","family":"Borg","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine & Clinical Institute, Aalborg University Hospital, Aalborg, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zaigham","family":"Saghir","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, Copenhagen, Denmark"},{"name":"Institute for 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