PDF herunterladen
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
› InstitutsangabenThis 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.
› Weitere Informationen
Auch verfügbar auf
    Lizenzen und Reprints

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


Publikationsverlauf

Artikel online veröffentlicht:
17. Juni 2024

© 2024. Thieme. All rights reserved.

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

 

  • References

  • 1 Homer JJ. Surgery in head and neck cancer: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol 2016; 130 (Suppl. 02) S68-S70
    CrossrefPubMedSuche in Google Scholar
  • 2 Steiner W. Results of curative laser microsurgery of laryngeal carcinomas. Am J Otolaryngol 1993; 14: 116-121
    CrossrefPubMedSuche in Google Scholar
  • 3 Ambrosch P, Kron M, Steiner W. Carbon dioxide laser microsurgery for early supraglottic carcinoma. Ann Otol Rhinol Laryngol 1998; 107: 680-688
    CrossrefPubMedSuche in Google Scholar
  • 4 Steiner W, Ambrosch P. Endoscopic laser surgery of the upper aerodigestive tract. Stuttgart, New York: Thieme; 2000
    Suche in Google Scholar
  • 5 Ambrosch P, Fazel A. Functional organ preservation in laryngeal and hypopharyngeal cancer. Laryngorhinootologie 2011; 90: S83-109
    CrossrefPubMedSuche in Google Scholar
  • 6 Iro H, Waldfahrer F, Altendorf-Hofmann A. et al. Transoral laser surgery of supraglottic cancer. Arch Otolaryngol Head Neck Surg 1998; 124: 1245-1250
    CrossrefPubMedSuche in Google Scholar
  • 7 Ambrosch P, Rödel R, Kron M. et al. Die transorale Lasermikrochirurgie des Larynxkarzinoms. Eine retrospektive Analyse von 657 Patientenverläufen. Onkologe 2001; 7: 505-512
    CrossrefPubMedSuche in Google Scholar
  • 8 Motta G, Esposito E, Tesla D. et al. CO2 laser treatment of supraglottic cancer. Head Neck 2004; 26: 442-446
    CrossrefPubMedSuche in Google Scholar
  • 9 Grant DG, Salassa JR, Hinni ML. et al. Transoral laser microsurgery for carcinoma of the supraglottic larynx. Otolaryngol Head Neck Surg 2007; 136: 900-906
    CrossrefPubMedSuche in Google Scholar
  • 10 Agrawal A, Moon J, Davis RK. et al. 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. Arch Otolaryngol Head Neck Surg 2007; 133: 1044-1050
    CrossrefPubMedSuche in Google Scholar
  • 11 Bumber Z, Prgomet D, Janjanin S. Endoscopic CO2 laser surgery for supraglottic cancer – ten years experience. Coll Antropol 2009; 33: 87-91
    PubMedSuche in Google Scholar
  • 12 Bussu F, Almadori G, De Corso E. et al. Endoscopic horizontal partial laryngectomy by CO2 laser in the management of supraglottic squamous cell carcinoma. Head Neck 2009; 31: 1196-1206
    CrossrefPubMedSuche in Google Scholar
  • 13 Peretti G, Piazza C, Ansarin M. et al. Transoral CO2 laser microsurgery for Tis-T3 supraglottic squamous cell carcinomas. Eur Arch Otorhinolaryngol 2010; 267: 1735-1742
    CrossrefPubMedSuche in Google Scholar
  • 14 González-Márquez R, Rodrigo JP, Llorente JL. Transoral CO2 laser surgery for supraglottic cancer. Eur Arch Otorhinolaryngol 2012; 269: 2081-2086
    CrossrefPubMedSuche in Google Scholar
  • 15 Canis M, Martin A, Ihler F. et al. Results of transoral laser microsurgery for supraglottic carcinoma in 277 patients. Eur Arch Otorhinolaryngol 2013; 270: 2315-2326
    CrossrefPubMedSuche in Google Scholar
  • 16 Vilaseca I, Bernal-Sprekelsen M. Transoral laser microsurgery for locally advanced laryngeal cancer. Acta Otorrinolaringol Esp 2013; 64: 140-149
    CrossrefPubMedSuche in Google Scholar
  • 17 Karatzanis AD, Psychogios G, Zenk J. et al. Evaluation of available surgical management options for early supraglottic cancer. Head Neck 2010; 32: 1048-1055
    CrossrefPubMedSuche in Google Scholar
  • 18 Prades JM, Simon PG, Timoshenko AP. et al. Extended and standard supraglottic laryngectomies: a review of 110 patients. Eur Arch Otorhinolaryngol 2005; 262: 947-952
    CrossrefPubMedSuche in Google Scholar
  • 19 Suarez C, Rodrigo JP, Herranz J. et al. Complications of supraglottic laryngectomy for carcinomas of the supraglottis and the base of tongue. Clin Otolaryngol Allied Sci 1996; 21: 87-90
    CrossrefPubMedSuche in Google Scholar
  • 20 Sevilla MA, Rodrigo JP, Llorente JL. et al. Supraglottic laryngectomy: analysis of 267 cases. Eur Arch Otorhinolaryngol 2008; 265: 11-16
    CrossrefPubMedSuche in Google Scholar
  • 21 Beckhardt RN, Murray JG, Ford CN. et al. Factors influencing outcome in supraglottic laryngectomy. Head Neck 1994; 16: 232-239
    CrossrefPubMedSuche in Google Scholar
  • 22 Logeman JA, Gibbons P, Rademaker AW. et al. Mechanisms of recovery of swallow after supraglottic laryngectomy. J Speech Hear Res 1994; 37: 965-974
    CrossrefPubMedSuche in Google Scholar
  • 23 Scola B, Fernandez-Vega M, Martinez T. et al. Management of cancer of the supraglottis. Otorhinolaryngol Head Neck Surg 2001; 124: 195-198
    CrossrefPubMedSuche in Google Scholar
  • 24 Roh JL, Kim DH, Park CI. Voice, swallowing and quality of life in patients after transoral laser surgery for supraglottic carcinomas. J Surg Oncol 2008; 98: 184-189
    CrossrefPubMedSuche in Google Scholar
  • 25 Cabanillas R, Rodrigo JP, Llorente JL. et al. Oncologic outcomes of transoral laser surgery of supraglottic carcinoma compared with a transcervical approach. Head Neck 2009; 31: 1196-1206
    CrossrefPubMedSuche in Google Scholar
  • 26 Schweinfurth JM, Silver SM. Patterns of swallowing after supraglottic laryngectomy. Laryngoscope 2000; 110: 1266-1270
    CrossrefPubMedSuche in Google Scholar
  • 27 Sobin I, Gospodarowicz M, Wittekind C. UICC International Union Against Cancer. TNM Classification of Malignant Tumours. 7th edition. Oxford: Blackwell Publishing Ltd; 2010
    Suche in Google Scholar
  • 28 Ambrosch P, Kron M, Pradier O. et al. 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. Otolaryngol Head Neck Surg 2001; 124: 180-187
    CrossrefPubMedSuche in Google Scholar
  • 29 Ferlito A, Rinaldo A, Silver CE. et al. Elective and therapeutic selective neck dissection. Oral Oncol 2006; 42: 14-25
    CrossrefPubMedSuche in Google Scholar
  • 30 Ambrosch P, Brinck U, Fischer G. et al. Special aspects of histopathologic diagnosis in laser microsurgery of cancers of the upper aerodigestive tract. Laryngorhinootologie 1994; 73: 78-83
    Thieme ConnectPubMedSuche in Google Scholar
  • 31 Hinni ML, Ferlito A, Brandwein-Gensler MS. et al. Surgical margins in head and neck cancer: a contemporary review. Head Neck 2013; 35: 1362-1370
    CrossrefPubMedSuche in Google Scholar
  • 32 Gregoire V, Ang K, Budach W. et al. Delineation of the neck node levels for head and neck tumors: A 2013 update. DAHANCA, EORTC, HKNPCSG, NCIC CTG, NCRI, RTOG, TROG consensus guidelines. Radiotherapy Oncology 2014; 110: 172-181
    CrossrefPubMedSuche in Google Scholar
  • 33 Rosenbek JC, Robbins JA, Roecker EB. et al. A Penetration-Aspiration Scale. Dysphagia 1996; 11: 93-98
    CrossrefPubMedSuche in Google Scholar
  • 34 Hey C, Pluschinski P, Zaretsky Y. et al. Penetration-Aspiration Scale according to Rosenbek. Validation of the German version for endoscopic dysphagia diagnostics HNO 2014; 62: 276-281
    CrossrefPubMedSuche in Google Scholar
  • 35 McCullough G, Rosenbek J, Robbins JA. et al. Ordinality and intervality of a penetration-aspiration scale. J Med Speech Lang Pathol 1998; 6: 65-72
    PubMedSuche in Google Scholar
  • 36 Chen AY, Frankowski R, Bishop-Leone J. et al. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer. Arch Otolaryngol Head Neck Surg 2001; 127: 870-876
    PubMedSuche in Google Scholar
  • 37 Bauer F, Seiss M, Gräussel E. et al. Swallowing-related quality of life in oral cavity cancer. The German version of the Anderson Dysphagia Inventory. HNO 2010; 58: 692-697
    CrossrefPubMedSuche in Google Scholar
  • 38 Jacobson BH, Johnson A, Grywalski C. et al. The voice handicap index (VHI): development and validation. Am J Speech Lang Pathol 1997; 6: 66-70
    CrossrefPubMedSuche in Google Scholar
  • 39 Nawka T, Wiesmann U, Gonnermann U. Validation of the German version of the voice handicap index. HNO 2003; 51: 921-30
    CrossrefPubMedSuche in Google Scholar
  • 40 National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) Version 4, NIH Publication No. 09–5410, June 2010. 2010
    PubMedSuche in Google Scholar