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Laryngorhinootologie 2025; 104(02): 94-102
DOI: 10.1055/a-2321-5968
Original Article

Multicenter clinical trial on functional evaluation of transoral laser microsurgery for supraglottic laryngeal carcinomas

Trial protocol for a single-arm, multicenter clinical trial (SUPRATOL)
Petra Ambrosch
1   Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, and Christian-Albrechts-University Kiel, Kiel, Germany
,
Asita Fazel
1   Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, and Christian-Albrechts-University Kiel, Kiel, Germany
,
Andreas Dietz
2   Clinic of Otorhinolaryngology, University of Leipzig, Leipzig, Germany
,
Rainer Fietkau
3   Department of Radiation Oncology, University of Erlangen-Nuremberg, Erlangen, Germany
,
Ralf Tostmann
4   Clinical Trial Unit, UMG, University of Göttingen, Göttingen, Germany
,
Christoph Borzikowsky
5   Institute of Medical Informatics and Statistics, Christian-Albrechts-University Kiel, Germany
› Author AffiliationsThis project is funded by DSZ-HNO, Bonn, Christian-Albrechts-University Kiel, and Beigelsche Stiftung zu Kiel
The SUPRATOL trial was sponsored by Universitätsklinikum Schleswig-Holstein (UKSH) and coordinated by the Department of Otorhinolaryngology, Head and Neck Surgery, UKSH, Campus Kiel, and Christian-Albrechts-University Kiel.

Clinical Trial: Registration number (trial ID): DRKS00004641, Trial registry: DSZ-HNO, Bonn, Christian-Albrechts-University Kiel, and Beigelsche Stiftung zu Kiel, Type of Study: The trial is a contribution to health service research and will improve knowledge on functional and oncologic outcomes of TLM-SGL in a multicenter setting.
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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).

Zusammenfassung

Hintergrund Die transorale Lasermikrochirurgie (TLM) ist eine anerkannte und effektive Behandlungsmethode für supraglottische Karzinome. Daten zu den onkologischen und in geringerem Maße auch zu den funktionellen Ergebnissen wurden hauptsächlich von einzelnen spezialisierten europäischen Kliniken veröffentlicht. Die TLM für supraglottische Karzinome wurde bislang noch nicht in einer multizentrischen Studie auf ihre Eignung als chirurgische Standardmethode untersucht.

Zielsetzung Untersuchung der Effektivität der transoralen lasermikrochirurgischen supraglottischen Larynxteilresektion (TLM-SGL) im Hinblick auf Schluckfunktion, onkologische Ergebnisse, Morbidität, Komplikationen und Lebensqualität in einer multizentrischen Studie.

Methoden Die Studie ist als multizentrische (ca. 25 Zentren), nicht-randomisierte, einarmige Studie mit einer angestrebten Zahl von 200 bisher unbehandelten Patienten mit Plattenepithelkarzinomen des supraglottischen Kehlkopfes T2/T3 N0–3 M0, UICC-Stadium II–IVa konzipiert. Die chirurgische Behandlung besteht aus TLM-SGL und elektiver oder therapeutischer ein- oder beidseitiger selektiver Neck Dissection (SND). Nach pathologischer Risikostratifizierung wird eine adjuvante Radio- (RT) oder Radiochemotherapie (RCT) durchgeführt. Die Nachbeobachtungszeit beträgt 2 Jahre. Die Schluckfunktion wird durch eine fiberendoskopische Schluckuntersuchung (FEES) beurteilt. Primärer Endpunkt ist das aspirationsfreie Schlucken nach 12 Monaten, ermittelt mit der FEES, und definiert als Grad < 6 der Penetrations-Aspirations-Skala (PAS). Sekundäre Endpunkte sind: lokale Kontrolle, Kehlkopferhalt, Gesamtüberleben, krankheitsfreies Überleben, Komplikationen und Nebenwirkungen der Behandlung, Prävalenz der Tracheostomie und der perkutanen endoskopischen Gastrostomie (PEG) sowie die Dysphagie-spezifische Lebensqualität, ermittelt mit dem MD Anderson Dysphagia Inventory (MDADI) und die stimmbezogene Lebensqualität, bewertet mit dem Voice Handicap Index (VHI).

Keywords

Multicenter clinical trial - health service research - supraglottic laryngeal carcinoma - transoral laser microsurgery - FEES - functional outcomes - oncologic outcomes - larynx preservation


Publication History

Article published online:
17 June 2024

© 2024. Thieme. All rights reserved.

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

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