{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T01:50:14Z","timestamp":1774576214185,"version":"3.50.1"},"reference-count":39,"publisher":"Georg Thieme Verlag KG","issue":"02","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Laryngorhinootologie"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>\n            Background Transoral laser microsurgery (TLM) is an accepted and effective treatment strategy for supraglottic carcinomas. Data on oncologic and to a lesser extent functional outcomes have been published by mainly European specialized single institutions. TLM for supraglottic carcinomas has never been tested in a multicenter trial on its applicability as surgical standard at every hospital.<\/jats:p><jats:p>\n            Objectives To test the efficacy of TLM supraglottic laryngectomy (TLM-SGL) in terms of swallowing function, oncologic outcome parameters, morbidity, complications of treatment, and quality of life in a multicenter setting.<\/jats:p><jats:p>\n            Methods The study is designed as a multicenter (approximately 25 centers), non-randomized, single-arm study with a targeted number of 200 previously untreated patients with squamous cell carcinomas (SCC) of the supraglottic larynx T2\/T3 N0\u20133 M0; UICC stage II\u2013IVa. The surgical treatment consists of TLM-SGL and elective or therapeutic uni- or bilateral selective neck dissection (SND). After pathologic risk stratification adjuvant radio- (RT) or radiochemotherapy (RCT) is indicated. Patients are followed-up for 2 years post surgically. Swallowing function is assessed by fibreoptic endoscopic evaluation of swallowing (FEES). The primary endpoint is aspiration-free swallowing at 12 months as established using FEES and defined as grade &lt; 6 of penetration-aspiration scale (PAS). Secondary endpoints include local control, larynx preservation, overall and disease-free survival, complications and side effects of treatment, prevalence of tracheostomy and percutaneous endoscopic gastrostomy (PEG)-tube-feeding, and dysphagia-specific quality of life (QoL) assessed by the MD Anderson Dysphagia Inventory (MDADI) as well as voice-related QoL assessed by the Voice Handicap Index (VHI).<\/jats:p>","DOI":"10.1055\/a-2321-5968","type":"journal-article","created":{"date-parts":[[2024,6,17]],"date-time":"2024-06-17T22:37:31Z","timestamp":1718663851000},"page":"94-102","source":"Crossref","is-referenced-by-count":6,"title":["Multicenter clinical trial on functional evaluation of transoral laser microsurgery for supraglottic laryngeal carcinomas"],"prefix":"10.1055","volume":"104","clinical-trial-number":[{"clinical-trial-number":"drks00004641","registry":"10.18810\/drks"}],"author":[{"given":"Petra","family":"Ambrosch","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, and Christian-Albrechts-University Kiel, Kiel, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asita","family":"Fazel","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, and Christian-Albrechts-University Kiel, Kiel, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Dietz","sequence":"additional","affiliation":[{"name":"Clinic of Otorhinolaryngology, University of Leipzig, Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rainer","family":"Fietkau","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, University of Erlangen-Nuremberg, Erlangen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ralf","family":"Tostmann","sequence":"additional","affiliation":[{"name":"Clinical Trial Unit, UMG, University of G\u00f6ttingen, G\u00f6ttingen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christoph","family":"Borzikowsky","sequence":"additional","affiliation":[{"name":"Institute of Medical Informatics and Statistics, Christian-Albrechts-University Kiel, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2024,6,17]]},"reference":[{"issue":"S 02","key":"ref1","doi-asserted-by":"publisher","first-page":"S68","DOI":"10.1017\/S0022215116000475","article-title":"Surgery in head and neck cancer: United Kingdom National Multidisciplinary Guidelines","volume":"130","author":"JJ Homer","year":"2016","journal-title":"J Laryngol Otol"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"116","DOI":"10.1016\/0196-0709(93)90050-h","article-title":"Results of curative laser microsurgery of laryngeal carcinomas","volume":"14","author":"W Steiner","year":"1993","journal-title":"Am J Otolaryngol"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"680","DOI":"10.1177\/000348949810700810","article-title":"Carbon dioxide laser microsurgery for early supraglottic carcinoma","volume":"107","author":"P Ambrosch","year":"1998","journal-title":"Ann Otol Rhinol Laryngol"},{"key":"ref4","volume-title":"Endoscopic laser surgery of the upper aerodigestive tract","author":"W Steiner","year":"2000"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"S83","DOI":"10.1055\/s-0030-1270449.","article-title":"Functional organ preservation in laryngeal and hypopharyngeal cancer","volume":"90","author":"P Ambrosch","year":"2011","journal-title":"Laryngorhinootologie"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"1245","DOI":"10.1001\/archotol.124.11.1245","article-title":"Transoral laser surgery of supraglottic cancer","volume":"124","author":"H Iro","year":"1998","journal-title":"Arch Otolaryngol Head Neck Surg"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1007\/s007610170103","article-title":"Die transorale Lasermikrochirurgie des Larynxkarzinoms. Eine retrospektive Analyse von 657 Patientenverl\u00e4ufen","volume":"7","author":"P Ambrosch","year":"2001","journal-title":"Onkologe"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"442","DOI":"10.1002\/hed.10395","article-title":"CO2 laser treatment of supraglottic cancer","volume":"26","author":"G Motta","year":"2004","journal-title":"Head Neck"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"900","DOI":"10.1016\/j.otohns.2006.12.015","article-title":"Transoral laser microsurgery for carcinoma of the supraglottic larynx","volume":"136","author":"DG Grant","year":"2007","journal-title":"Otolaryngol Head Neck Surg"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"1044","DOI":"10.1001\/archotol.133.10.1044","article-title":"Transoral carbon dioxide laser supraglottic laryngectomy and irradiation in stage I, II, and III squamous cell carcinoma of the supraglottic larynx: report of Southwest Oncology Group Phase 2 Trial S9709","volume":"133","author":"A Agrawal","year":"2007","journal-title":"Arch Otolaryngol Head Neck Surg"},{"key":"ref11","first-page":"87","article-title":"Endoscopic CO2 laser surgery for supraglottic cancer \u2013 ten years experience","volume":"33","author":"Z Bumber","year":"2009","journal-title":"Coll Antropol"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"1196","DOI":"10.1002\/hed.21085","article-title":"Endoscopic horizontal partial laryngectomy by CO2 laser in the management of supraglottic squamous cell carcinoma","volume":"31","author":"F Bussu","year":"2009","journal-title":"Head Neck"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"1735","DOI":"10.1007\/s00405-010-1284-1","article-title":"Transoral CO2 laser microsurgery for Tis-T3 supraglottic squamous cell carcinomas","volume":"267","author":"G Peretti","year":"2010","journal-title":"Eur Arch Otorhinolaryngol"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"2081","DOI":"10.1007\/s00405-012-2016-5","article-title":"Transoral CO2 laser surgery for supraglottic cancer","volume":"269","author":"R Gonz\u00e1lez-M\u00e1rquez","year":"2012","journal-title":"Eur Arch Otorhinolaryngol"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"2315","DOI":"10.1007\/s00405-012-2327-6","article-title":"Results of transoral laser microsurgery for supraglottic carcinoma in 277 patients","volume":"270","author":"M Canis","year":"2013","journal-title":"Eur Arch Otorhinolaryngol"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"140","DOI":"10.1016\/j.otorri.2012.01.013","article-title":"Transoral laser microsurgery for locally advanced laryngeal cancer","volume":"64","author":"I Vilaseca","year":"2013","journal-title":"Acta Otorrinolaringol Esp"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"1048","DOI":"10.1002\/hed.21289","article-title":"Evaluation of available surgical management options for early supraglottic cancer","volume":"32","author":"AD Karatzanis","year":"2010","journal-title":"Head Neck"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"947","DOI":"10.1007\/s00405-004-0882-1","article-title":"Extended and standard supraglottic laryngectomies: a review of 110 patients","volume":"262","author":"JM Prades","year":"2005","journal-title":"Eur Arch Otorhinolaryngol"},{"key":"ref19","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1111\/j.1365-2273.1996.tb01032.x","article-title":"Complications of supraglottic laryngectomy for carcinomas of the supraglottis and the base of tongue","volume":"21","author":"C Suarez","year":"1996","journal-title":"Clin Otolaryngol Allied Sci"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1007\/s00405-007-0415-9","article-title":"Supraglottic laryngectomy: analysis of 267 cases","volume":"265","author":"MA Sevilla","year":"2008","journal-title":"Eur Arch Otorhinolaryngol"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"232","DOI":"10.1002\/hed.2880160305","article-title":"Factors influencing outcome in supraglottic laryngectomy","volume":"16","author":"RN Beckhardt","year":"1994","journal-title":"Head Neck"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"965","DOI":"10.1044\/jshr.3705.965","article-title":"Mechanisms of recovery of swallow after supraglottic laryngectomy","volume":"37","author":"JA Logeman","year":"1994","journal-title":"J Speech Hear Res"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"195","DOI":"10.1067\/mhn.2001.112202","article-title":"Management of cancer of the supraglottis","volume":"124","author":"B Scola","year":"2001","journal-title":"Otorhinolaryngol Head Neck Surg"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"184","DOI":"10.1002\/jso.21101","article-title":"Voice, swallowing and quality of life in patients after transoral laser surgery for supraglottic carcinomas","volume":"98","author":"JL Roh","year":"2008","journal-title":"J Surg Oncol"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"1196","DOI":"10.1002\/hed.20778","article-title":"Oncologic outcomes of transoral laser surgery of supraglottic carcinoma compared with a transcervical approach","volume":"31","author":"R Cabanillas","year":"2009","journal-title":"Head Neck"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"1266","DOI":"10.1097\/00005537-200008000-00008","article-title":"Patterns of swallowing after supraglottic laryngectomy","volume":"110","author":"JM Schweinfurth","year":"2000","journal-title":"Laryngoscope"},{"key":"ref27","volume-title":"TNM Classification of Malignant Tumours. 7th edition","author":"I Sobin","year":"2010"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"180","DOI":"10.1067\/mhn.2001.111598","article-title":"Efficacy of selective neck dissection: a review of 503 cases of elective and therapeutic treatment of the neck in squamous cell carcinoma of the upper aerodigestive tract","volume":"124","author":"P Ambrosch","year":"2001","journal-title":"Otolaryngol Head Neck Surg"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1016\/j.oraloncology.2005.03.009","article-title":"Elective and therapeutic selective neck dissection","volume":"42","author":"A Ferlito","year":"2006","journal-title":"Oral Oncol"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1055\/s-2007-997084","article-title":"Special aspects of histopathologic diagnosis in laser microsurgery of cancers of the upper aerodigestive tract","volume":"73","author":"P Ambrosch","year":"1994","journal-title":"Laryngorhinootologie"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"1362","DOI":"10.1002\/hed.23110","article-title":"Surgical margins in head and neck cancer: a contemporary review","volume":"35","author":"ML Hinni","year":"2013","journal-title":"Head Neck"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"172","DOI":"10.1016\/j.radonc.2013.10.010","article-title":"Delineation of the neck node levels for head and neck tumors: A 2013 update. DAHANCA, EORTC, HKNPCSG, NCIC CTG, NCRI, RTOG, TROG consensus guidelines","volume":"110","author":"V Gregoire","year":"2014","journal-title":"Radiotherapy Oncology"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1007\/BF00417897","article-title":"A Penetration-Aspiration Scale","volume":"11","author":"JC Rosenbek","year":"1996","journal-title":"Dysphagia"},{"key":"ref34","doi-asserted-by":"publisher","first-page":"276","DOI":"10.1007\/s00106-013-2815-z","article-title":"Penetration-Aspiration Scale according to Rosenbek","volume":"62","author":"C Hey","year":"2014","journal-title":"Validation of the German version for endoscopic dysphagia diagnostics HNO"},{"key":"ref35","first-page":"65","article-title":"Ordinality and intervality of a penetration-aspiration scale","volume":"6","author":"G McCullough","year":"1998","journal-title":"J Med Speech Lang Pathol"},{"key":"ref36","first-page":"870","article-title":"The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer","volume":"127","author":"AY Chen","year":"2001","journal-title":"Arch Otolaryngol Head Neck Surg"},{"key":"ref37","doi-asserted-by":"publisher","first-page":"692","DOI":"10.1007\/s00106-010-2117-7","article-title":"Swallowing-related quality of life in oral cavity cancer. The German version of the Anderson Dysphagia Inventory","volume":"58","author":"F Bauer","year":"2010","journal-title":"HNO"},{"key":"ref38","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1044\/1058-0360.0603.66","article-title":"The voice handicap index (VHI): development and validation","volume":"6","author":"BH Jacobson","year":"1997","journal-title":"Am J Speech Lang Pathol"},{"key":"ref39","doi-asserted-by":"publisher","first-page":"921","DOI":"10.1007\/s00106-003-0909-8","article-title":"Validation of the German version of the voice handicap index","volume":"51","author":"T Nawka","year":"2003","journal-title":"HNO"}],"container-title":["Laryngo-Rhino-Otologie"],"original-title":[],"language":"de","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-2321-5968.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,3]],"date-time":"2025-02-03T23:30:57Z","timestamp":1738625457000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-2321-5968"}},"subtitle":["Trial protocol for a single-arm, multicenter clinical trial (SUPRATOL)"],"short-title":[],"issued":{"date-parts":[[2024,6,17]]},"references-count":39,"journal-issue":{"issue":"02","published-online":{"date-parts":[[2025,2,3]]},"published-print":{"date-parts":[[2025,2]]}},"URL":"https:\/\/doi.org\/10.1055\/a-2321-5968","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0935-8943","1438-8685"],"issn-type":[{"value":"0935-8943","type":"print"},{"value":"1438-8685","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,17]]}}}