Feasibility and Safety of Office-Based Transnasal Balloon Dilation for Neopharyngeal and Proximal Esophageal Strictures in Patients with a History of Head and Neck Carcinoma

This prospective case series was conducted from May 2018 until September 2019 at the department of Otorhinolaryngology and Head and Neck Surgery in a tertiary referral head and neck center in The Netherlands. Eligible study participants were adult patients with a history of head and neck carcinoma having symptoms of dysphagia caused by a neopharyngeal or proximal esophageal stricture. Additionally, patients had to have a sufficiently patent nasal cavity for the transnasal esophagoscope to pass through. Patients in whom general anesthesia was contra-indicated due to comorbidities and patients who preferred to undergo dilation under topical anesthesia were included. Written informed consent was acquired from each patient.

Transnasal balloon dilation was performed in the outpatient clinic under topical anesthesia. First, both nasal cavities were anesthetized with cotton pledgets soaked in 10% lidocaine spray and 0.1% xylometazoline solution. After 10–15 min, these pledgets were removed. Subsequently, a maximum of 10 sprays of 10% lidocaine was administered through the oropharynx to anesthetize the (laryngo-)pharyngeal region. A transnasal esophagoscope with 2 mm diameter working channel (EE1580K, Pentax Medical, Uithoorn, The Netherlands, diameter 5.1 mm) was introduced in the most patent nasal cavity and the stricture was visualized. Digital images were processed using a video processor (EPK-i5000-HD, Pentax Medical, Uithoorn, The Netherlands). If the stricture was large enough for the esophagoscope to pass, the entire esophagus was visualized. Four sizes of balloon dilators were available, i.e. 6–8, 8–10, 10–12, and 12–15 mm diameter, with a balloon length of 5.5 cm (CRE™ PRO Wireguided, Boston Scientific Corporation, USA). The balloon size was chosen based on the extent of the stricture, which can be estimated in reference to the endoscope tip (5.1 mm). Alongside the esophagoscope, the balloon dilator with guidewire was introduced in the nasal cavity and the balloon was positioned across the area to be dilated. By using a syringe filled with water placed in an integrated pressure gauge (Alliance™ II Integrated Inflation Device, Boston Scientific Corporation, USA), the balloon dilators were inflated under constant visualization while monitoring pressure and balloon size. After 1 min, the balloon was fully deflated. If the patient tolerated the first dilation, a second dilation was performed with 1 min between the inflations. At each subsequent inflation, the dilator diameter was increased with a maximum of 1.0–1.5 mm. In accordance with the clinical esophageal dilation guidelines, a maximum of 3 subsequent inflations in 1 session were performed [15]. After each inflation, the dilation site was inspected for mucosal injury. The procedure was aborted when mucosal defects occurred or when the patient did not tolerate further dilation because of pain or discomfort. The target diameter of the balloon was 15 mm because this luminal diameter is expected to be sufficient for patients to be relieved of dysphagia [15]. If this target was not reached after the dilation session and the patient was willing to undergo another dilation procedure, this was planned 2–4 weeks later. When a luminal patency of 15 mm was achieved, a follow-up consultation by phone was planned after 4 and 8 weeks. If the patient had recurring or persisting symptoms and was unwilling to undergo another transnasal dilation, alternative treatment options were discussed.

Demographical data of the included patients were collected. At all pre- and post-procedural visits or consultations by phone, dysphagia grade was assessed using a score ranging 0–5: (0) normal swallowing function (no or minimal dietary modifications, normal duration of taking a meal, no aspiration) and no complaints of dysphagia; (1) normal swallowing function with intermittent complaints of dysphagia with solid food; (2) unable to swallow solid food; (3) unable to swallow minced food; (4) unable to swallow pureed / liquidized food; (5) unable to swallow clear liquids or saliva [16]. Data on the procedures were recorded, i.e. whether the endoscope could be passed through the stricture, the maximal diameter of dilations, the number of repeated dilation procedures, completion rate (if the patient had undergone 3 subsequent dilations in 1 session), and complications.

After each procedure, patients were requested to fill out a questionnaire concerning the procedural experiences. Patients were asked to rate their experiences according to pain in the nose and throat, complaints of gagging, ructus or nausea, and to give a general opinion on tolerability of the procedure. For this rating, VAS (visual analogue scale) was used with scores ranging from 0–10; 0 meaning no discomfort, 10 meaning unbearable discomfort.

For the data analyses, IBM SPSS statistics version 25 (IBM Corporation, Armonk, NY, USA) for Windows (Microsoft Corporation, Redmond, WA, USA) was used.