Investigators at the University of Pittsburgh (UP), Department of Otolaryngology, received a 2-year NIH “Exploratory/Development Grant” on April 1, 2014 to evaluate the efficacy of the new and controversial balloon dilation for Eustachian tube dysfunction (ETD) in 18 to 50 old patients. Cuneyt M. Alper, MD is the Principal Investigator. Eustachian tube (ET) testing will be conducted at the Middle Ear Physiology Laboratory. There have been popular balloon dilation procedures in patients with sinusitis and obstructive narrowing of the lower airway by Otolaryngologists for several years but most recently this procedure has been advocated for patients, adults and children, who have suspected ETD (physician diagnosed) with and without middle- ear disease. There have been 15 articles published in the peer-reviewed literature during the past 5 years describing studies of feasibility, safety and purported efficacy. In addition, there have been courses teaching physicians this procedure, presentations at a national society of Otolaryngologists in the US, and has been increasingly used in Europe. Nevertheless, the few clinical studies published failed to evaluate the direct effect of the procedure on ET function, included small numbers of patients, had weak definitions of “cure,” failed to study patients for the long term, and most importantly, none were randomized controlled trials (RCT), which is the accepted scientific method to establish efficacy. Thus, balloon dilation of the ET has not been proven to be effective and remains experimental. Indeed, this grant affirms that NIH agrees that this procedure is of uncertain efficacy.
The new NIH-funded grant is not designed to test the safety and efficacy of balloon dilation of the ET in an RCT, but if this pilot study proves to be promising, then such a trial would be the next step. In addition, none of the published studies evaluated conditions that may adversely affect the ET, such as sinusitis, allergy, and gastroesophageal reflux (GERD), whereas this new study does include evaluating ET function before and after treatment of these relatively common maladies, since successful treatment would make the balloon procedure unnecessary.
In the April, 2014 issue of Otolaryngology-Head and Neck (volume 150, no 4:505-508) journal, the official publication of the American Academy of Otolaryngology-Head and Neck, an editorial by the editor Richard M. Rosenfeld, MD, MPH, specifically questions the safety and efficacy of balloon dilations for ear disease and deems it as being a “Gizmo.”
SUMMARY OF NIH GRANT
The Eustachian tube (ET) is a potential communication between the middle ear (ME) and nasopharynx (NP). The lumen of the ET is usually closed but can be transiently opened by the activity of the paratubal muscles. It is known that the ET opening function (ETF) is impaired in patients presenting with otitis media with effusion (OME) and that constitutive ET dysfunction (ETD) can cause the persistence of the disease as a chronic condition. No standard medical therapy is effective in improving ETF or in resolving persistent OME long-term and the usual treatment is insertion of ventilation tubes (VTs) which bypasses the ET to maintain an open communication between the ME and environment. However, the functional half-life of a VT in adults is approximately 4-9 months and the disease often recurs when the VT is extruded or becomes non-functional. Recently, an alternative and perhaps more permanent surgical treatment for ETD, balloon dilation of the ET (BDET), has been described as being relatively easy to perform, safe and efficacious in resolving OME and is being actively promoted to practicing surgeons for adoption in their practices. However, the few clinical studies that evaluated the efficacy of the procedure included small sample sizes, a weak definition of “cure” and were not randomized, blinded or sham controlled. Importantly, none of the studies evaluated the direct effect of the procedure on ETF. Here, we propose to conduct a pilot study to define the safety and efficacy with respect to improving ETF of BDET. Over a 2-year period, we will identify otherwise healthy patients between 18-50 years of age who have VTs inserted as a treatment for OME caused by ETD. Forty of the patients who provide informed consent for experimental, unilateral BDET will be enrolled as subjects in the study. They will have baseline ETF tests and endoscopic ET/NP evaluations to document the presence or absence of ETD. The subset of subjects with ETD will be evaluated for 3 common conditions that can down-grade ETF: allergy, sinusitis and gastro-esophageal reflux disease. If a condition is diagnosed, the subject will be treated medically as appropriate; otherwise, they will be treated with intranasal steroids. ETF tests and nasal endoscopic examinations will be repeated and 20 subjects with ETD unresponsive to medical treatment will have unilateral BDET done under monitored anesthesia care. For safety and measurement of ET luminal geometry, a modified CT protocol focused on the ET and ME will be done prior to the procedure. ETF tests and endoscopic evaluations will be repeated at 1, 3 and 6 months and the CT scan will be repeated at 3 months after the BDET. The data will be analyzed to: define the frequency and cause of ETD in unselected adults with OME; determine if a short course of medical treatment for co-morbid conditions or for inflammation can be used to disqualify subjects from consideration for BDET, identify the type and frequency of complications associated with the procedure, describe the effect of the procedure on ETF and ET luminal geometry. These results will determine if a multi-center, phase II/III clinical trial of the procedure is warranted.
ELIGIBLITY OF CANDIDATES FOR THE STUDY
Those patients who are otherwise healthy, 18-50 years of age, and have had middle-ear disease in the past, and who have a ventilation tube in one or both ear drums may be candidates. The study requires 1 screening visit (up to 3-4 hours). Full participation requires 7 visits over about 8 months. The study involves ET function testing and examinations, x-rays, and if eligible, balloon dilation procedure done under anesthesia. All research procedures and testing are free of charge. Subjects will be reimbursed for transportation and for participation ($1400 for full participation).
For more information, patients interested in being evaluated for this new study can call Julie Banks, 412-692-3595, at the University of Pittsburgh Middle-Ear Physiology Laboratory: