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Navigation-Assisted Balloon Eustachian Tuboplasty for Eustachian Tube Dilatory Dysfunction.

ABSTRACT: OBJECTIVES:Balloon Eustachian tuboplasty (BET) is a novel treatment method for Eustachian tube dilatory dysfunction (ETD). However, surgeons cannot identify the insertion depth of the catheter during BET, resulting in potential risks such as internal carotid artery (ICA) injury. Therefore, we developed an image-guided navigation balloon catheter to identify the insertion depth of the catheter and to establish awareness of the proximity of the ICA. This study aimed to evaluate the technical feasibility of this image-guided navigation balloon catheter system in patients with ETD. METHODS:Twenty-nine patients (38 ears; nine bilateral; 21 right ears, and 17 left ears) diagnosed with ETD were assessed. All patients who showed no improvement despite medical therapy with topical steroids, anti-reflux medication, and the Valsalva maneuver for a minimum of 6 weeks received image-guided navigation-assisted BET. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score and Valsalva maneuver were used to evaluate patients' symptoms preoperatively and at the postoperative follow-up. RESULTS:Image-guided navigation-assisted BET was safely performed in all patients. The mean total ETDQ-7 score was 25.4±7.1 preoperatively, 17.5±6.2 at 1 month, and 15.2±7.0 at 6 months (P<0.001). In total, a Valsalva maneuver was possible for 28 of 38 ears (73.7%) at the time of the patient's final visit at 6 months post-procedure. CONCLUSION:Image-guided navigation balloon catheters are a potentially valuable tool in patients with ETD. Their use is also technically feasible and safe when performing BET to treat ETD.

SUBMITTER: Choi SW

PROVIDER: S-EPMC7669314 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Navigation-Assisted Balloon Eustachian Tuboplasty for Eustachian Tube Dilatory Dysfunction.

Choi Sung-Won SW Lee Seok-Hwan SH Oh Se-Joon SJ Kong Soo-Keun SK

Clinical and experimental otorhinolaryngology 20200512 4

<h4>Objectives</h4>Balloon Eustachian tuboplasty (BET) is a novel treatment method for Eustachian tube dilatory dysfunction (ETD). However, surgeons cannot identify the insertion depth of the catheter during BET, resulting in potential risks such as internal carotid artery (ICA) injury. Therefore, we developed an image-guided navigation balloon catheter to identify the insertion depth of the catheter and to establish awareness of the proximity of the ICA. This study aimed to evaluate the technic ...[more]

PMID: 32392639

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Project description:BackgroundOtitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure.Methods and analysisThis is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs).DiscussionThis is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial's rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy.Trial registrationChinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452 .

Dataset Information

Navigation-Assisted Balloon Eustachian Tuboplasty for Eustachian Tube Dilatory Dysfunction.

Publications

Navigation-Assisted Balloon Eustachian Tuboplasty for Eustachian Tube Dilatory Dysfunction.

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