The tendency toward better hearing improvement in the treatment group, the rather conservative inclusion criteria, the limited placebo-controlled observation period and the absence of serious adverse events supports further investigation local inner ear drug delivery as a first or second line treatment option for ISSHL.
The average pure-tone threshold after intratympanic salvage treatment showed a statistically significant improvement of 15 dB (95% CI 7-24 dB; p<0.001). After exclusion of patients with complete anacusis, i.e. a non-measurable hearing threshold, the local therapy group showed a significantly better improvement (mean 19 dB; 95% CI 6-32 dB) than the historical control group (mean 5 dB; 95% CI -2-11 dB; p<0.05).
Background: The German multicenter randomized phase II larynx organ preservation (LOP) trial DeLOS-II was carried out to prove the hypothesis that cetuximab (E) added to induction chemotherapy (IC) and radiotherapy improves laryngectomy-free survival (LFS; survival with preserved larynx) in locally advanced laryngeal/hypopharyngeal cancer (LHSCC).Patients and methods: Treatment-naïve patients with stage III/IV LHSCC amenable to total laryngectomy (TL) were randomized to three cycles IC with TPF [docetaxel (T) and cisplatin (P) 75 mg/m 2 /day 1, 5-FU (F) 750 mg/m 2 /day days 1-5] followed by radiotherapy (69.6 Gy) without (A) or with (B) standard dose cetuximab for 16 weeks throughout IC and radiotherapy (TPFE). Response to first IC-cycle (IC-1) with !30% endoscopically estimated tumor surface shrinkage (ETSS) was used to define early responders; early salvage TL was recommended to non-responders. The primary objective was 24 months LFS above 35% in arm B.
Wullstein, the founder of modern microscopic ear surgery, already used an oto-endoscope intraoperatively. However, it is only after the recent development of modern video-endoscopy with high-definition, 4K, and 3‑dimensional imaging that endoscopically guided surgery of the middle ear is gaining some importance. Key ventilation routes like the isthmus tympani and the epitympanic diaphragm can be visualized far better using an endoscope than with a microscope. Going through the external meatus, surgery of middle ear pathologies is possible without external incision. This type of primary endoscopic ear surgery has to be distinguished from secondary endoscopic ear surgery, where standard microscopic ear surgery is supplemented by endoscopic surgery. Having to hold the endoscope in one hand, surgery has to be performed single-handedly, which is awkward. In cases of extensive bone removal or excessive bleeding, the view through the endoscope lens is obscured; therefore; the endoscope cannot fully substitute the microscope. It is, however, an interesting adjunct to microscopic ear surgery.
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