Journal Article Multicenter Study Clinical Trial Ppublish 2 citations
PubMed: 38885651 DOI: 10.1055/a-2321-5968
Multicenter clinical trial on functional evaluation of transoral laser microsurgery for supraglottic laryngeal carcinomas.
Laryngorhinootologie 104(2):94-102
Authors: Petra Ambrosch, Asita Fazel, Andreas Dietz, Rainer Fietkau, Ralf Tostmann, Christoph Borzikowsky
Affiliations
- Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, and Christian-Albrechts-University Kiel, Kiel, Germany.
- Clinic of Otorhinolaryngology, University of Leipzig, Leipzig, Germany.
- Department of Radiation Oncology, University of Erlangen-Nuremberg, Erlangen, Germany.
- Clinical Trial Unit, UMG, University of Göttingen, Göttingen, Germany.
- Institute of Medical Informatics and Statistics, Christian-Albrechts-University Kiel, Germany.
Abstract
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.
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.
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 N0-3 M0; UICC stage II-IVa. 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 < 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).
MeSH
Quality Of Life, Larynx, Lasers, Microsurgery, Therapeutics, Deglutition