Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

Inclusion Criteria: * Dysphagia due to benign esophageal stricture (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy) requiring esophageal dilation * Requiring first esophageal dilation for dysphagia due to a severe benign esophageal stricture with no patency for standard upper endoscope (9-10mm diameter) * No history of esophageal endoscopic dilations for benign strictures the past 6 months * Dysphagia for solid, semisolid or liquid food (dysphagia score ≥ 2 \[Ogilvie\]16, and dysphagia score ≤ 21 \[Dakkak and Bennett\]19, see appendix) * Written informed consent Exclusion Criteria: * Patient \< 18 years old * Patient is unwilling or unable to sign and date the informed consent * Patient is unwilling or unable to comply with the follow-up schedule * Patient is unable to understand informed consent and fill in the questionnaires due to a language barrier * Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 month * Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study * Previous esophageal dilation for benign stricture within the past 6 months * Patient with a life expectancy \< 12 months * Patient with a known eosinophilic esophagitis or motility disorder (such as achalasia) * Patients with a known malignant esophageal stricture * Patients with a benign stricture due to a previous performed laryngectomy Endoscopic exclusion criteria: * Benign strictures in the upper part of the esophagus too close to the cricopharyngeal muscle (for the purpose of this protocol, within 1½ cm of the upper esophageal sphincter) * Patients with stricture ≥ 10 cm in length * Patients with an active esophageal perforation, leak, fistula, or varices * Stricture within necrotic chronically bleeding tumors * Highly suspected esophageal malignancy * Stricture within polypoid lesions * Known or strongly suspected dysmotility esophageal disorder * Patient with high suspicion for an esophageal web, Schatzki ring, eosinophilic esophagitis, or motility disorder (such as achalasia)