Octreotide VS Placebo in Prevention of Salivary Fistulae After Post Radiation Salvage Surgery

Summary

Salivary fistulae have been the bane of surgical salvage in the era of primary chemoradiation for head and neck (H\&N) cancers. The "blame"of prior chemoradiation tissue damage encouraged compensatory surgical techniques that focused on the insertion of non-irradiated tissue into the field. This study emphasizes a paradigm shift in the understanding and treatment of pharyngocutaneous fistulae. The detrimental effects of salivary enzymes on tissue healing and surgical anastomoses are addressed and novel treatment strategy is outlined.

Timeline

Start

2015-10

Primary completion

2021-06

Completion

2021-06

Publications

• Background Gilbert MR, Sturm JJ, Gooding WE, Johnson JT, Kim S. Pectoralis major myofascial onlay and myocutaneous flaps and pharyngocutaneous fistula in salvage laryngectomy. Laryngoscope. 2014 Dec;124(12):2680-6. doi: 10.1002/lary.24796. Epub 2014 Jul 30.
• Background Agra IM, Carvalho AL, Pontes E, Campos OD, Ulbrich FS, Magrin J, Kowalski LP. Postoperative complications after en bloc salvage surgery for head and neck cancer. Arch Otolaryngol Head Neck Surg. 2003 Dec;129(12):1317-21. doi: 10.1001/archotol.129.12.1317.
• Background Bomeli SR, Desai SC, Johnson JT, Walvekar RR. Management of salivary flow in head and neck cancer patients--a systematic review. Oral Oncol. 2008 Nov;44(11):1000-8. doi: 10.1016/j.oraloncology.2008.02.007. Epub 2008 May 16.
• Background Loguercio C, de Sio I, Romano M, del Vecchio Blanco C, Coltorti M. Effect of somatostatin on salivary secretion in man. Digestion. 1987;36(2):91-5. doi: 10.1159/000199405.
• Background Spinell C, Ricci E, Berti P, Miccoli P. Postoperative salivary fistula: therapeutic action of octreotide. Surgery. 1995 Jan;117(1):117-8. doi: 10.1016/s0039-6060(05)80242-9. No abstract available.
• Background Victora CG, Huttly SR, Fuchs SC, Olinto MT. The role of conceptual frameworks in epidemiological analysis: a hierarchical approach. Int J Epidemiol. 1997 Feb;26(1):224-7. doi: 10.1093/ije/26.1.224.

Drugs

Indications