203 the submandibular gland were percutaneous, and ethanol was combined with sodium tetradecyl sulfate, which induces a greater extent of inflammation.86 The submandibular duct was not cannulated because there was no experience with submandibular duct surgery. There is broad experience with submandibular duct surgery in our institution, and cannulation of the submandibular duct is easily performed. In conclusion, intraductal ethanol infusion is safe and effective. 2-DL is a safe and effective treatment for drooling, but there is a certain degree of relapse. This study aims to evaluate the feasibility of submandibular duct ligation right after intraductal ethanol infusion into the submandibular salivary gland ablation (Ethanol two-duct ligation [E-2DL]) to improve treatment effect, prevent recurrence and hinder alternative salivary pathway-formation. METHODS Primary objective 1. The primary objective was to evaluate the procedure’s feasibility defined by adverse events and postoperative complaints (i.e. safety). Adverse events (AEs). AEs are classified as related or unrelated to the surgical procedure where pain, dysphagia and xerostomia for less than 14 days is considered an ordinary post-operative course.68, 91 Submandibular swelling for less than four weeks without other sequelae is considered a normal post-operative course. AE that required (prolonged) hospitalization, surgical re-intervention, caused permanent injury or are life-threatening are defined as Serious Adverse Events (SAE). When one SAE related to the procedure occurs, we will discontinue the study for consultation with the Institutional Review Board (IRB). When one patient suffers an SAE, we will internally discuss whether these events were related to the procedure. If these events are related to the procedure, we will abort the pilot study. We deem the pilot study successful when one or fewer patients suffer from an SAE related to the procedure.
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