{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,6,26]],"date-time":"2025-06-26T08:06:35Z","timestamp":1750925195468,"version":"3.32.0"},"reference-count":31,"publisher":"Walter de Gruyter GmbH","issue":"4","license":[{"start":{"date-parts":[[2024,11,18]],"date-time":"2024-11-18T00:00:00Z","timestamp":1731888000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_pp-2024-0014_abs_001\">\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) is a minimally invasive cancer-directed therapy for patients with malignant pleural effusion (MPE) and\/or pleural metastasis (PLM). PITAC is based on Pressurized IntraPeritoneal Aerosol Chemotherapy, which has proven to be safe and feasible. Since 2012, 47 PITACs have been published, and prospective data on feasibility, safety and potential local response are lacking.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_pp-2024-0014_abs_002\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The prospective, controlled, phase-I study is designed to treat MPE with PITAC. There are no data to support the estimated number of patients needed, but previous experience estimates the non-access rate to 20\u202f%. Twenty eligible patients with MPE will receive two or more PITACs at four-week intervals. During video-assisted thoracoscopy, MPE and\/or pleural lavage fluid is evacuated, and the extent of visible PLM is assessed. Pleural biopsies are collected, if possible, for histological response as per Thoracic Regression Grading Score (TRGS). Patients are screened for treatment-related intra- and postoperative complications. The primary outcome is the number of patients with Clavien-Dindo\u00a0\u22653b or Common Terminology Criteria for Adverse Events\u22654 within 30\u00a0days. Secondary objectives include PLM-score, TRGS and cytology, length of hospitalization, personnel safety, quality of life, and change in MPE volume.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_pp-2024-0014_abs_003\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>PITAC is expected to be safe and feasible for patients and personnel, and achieve positive results in the reduction of MPE volume.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_pp-2024-0014_abs_004\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The results may significantly impact the next clinical, technical, and scientific steps in the implementation of PITAC. Given the suboptimal treatment options for MPE and the seemingly promising results of PITAC, we find the implementation of PITAC ethically reasonable and sound.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/pp-2024-0014","type":"journal-article","created":{"date-parts":[[2024,11,20]],"date-time":"2024-11-20T21:00:17Z","timestamp":1732136417000},"page":"141-148","source":"Crossref","is-referenced-by-count":3,"title":["Implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) for the treatment of patients with malignant pleural effusion: study protocol for the Danish phase-I PITAC-OPC5 study"],"prefix":"10.1515","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-9615-8704","authenticated-orcid":false,"given":"Pernille Schj\u00f8dt","family":"Hansen","sequence":"first","affiliation":[{"name":"Odense PIPAC Center (OPC) and Odense Pancreas Center (OPAC) , Odense University Hospital , Odense , Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5719-4916","authenticated-orcid":false,"given":"Martin","family":"Graversen","sequence":"additional","affiliation":[{"name":"Odense PIPAC Center (OPC) and Odense Pancreas Center (OPAC) , Odense University Hospital , Odense , Denmark"},{"name":"Department of Surgery, HPB and Upper GI Section , Odense University Hospital , Odense , Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9466-2333","authenticated-orcid":false,"given":"S\u00f6nke","family":"Detlefsen","sequence":"additional","affiliation":[{"name":"Odense PIPAC Center (OPC) and Odense Pancreas Center (OPAC) , Odense University Hospital , Odense , Denmark"},{"name":"Department of Pathology , Odense University Hospital , Odense , Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8922-8877","authenticated-orcid":false,"given":"Alan Patrick","family":"Ainsworth","sequence":"additional","affiliation":[{"name":"Odense PIPAC Center (OPC) and Odense Pancreas Center (OPAC) , Odense University Hospital , Odense , Denmark"},{"name":"Department of Surgery, HPB and Upper GI Section , Odense University Hospital , Odense , Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claus Wilki","family":"Fristrup","sequence":"additional","affiliation":[{"name":"Odense PIPAC Center (OPC) and Odense Pancreas Center (OPAC) , Odense University Hospital , Odense , Denmark"},{"name":"Department of Surgery, HPB and Upper GI Section , Odense University Hospital , Odense , Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lise","family":"Eckhoff","sequence":"additional","affiliation":[{"name":"Department of Oncology , Odense University Hospital , Odense , Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mia","family":"Jelin-Klaric","sequence":"additional","affiliation":[{"name":"Department of Oncology , Odense University Hospital , Odense , Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7270-5005","authenticated-orcid":false,"given":"Michael Bau","family":"Mortensen","sequence":"additional","affiliation":[{"name":"Odense PIPAC Center (OPC) and Odense Pancreas Center (OPAC) , Odense University Hospital , Odense , Denmark"},{"name":"Faculty of Health Sciences , Institute of Clinical Research, University of Southern Denmark , Odense , Denmark"},{"name":"Department of Surgery, HPB and Upper GI Section , Odense University Hospital , Odense , Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"374","published-online":{"date-parts":[[2024,11,18]]},"reference":[{"doi-asserted-by":"crossref","unstructured":"Asciak, R, Rahman, NM. 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