Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

Progressive Versus Conservative Dilation Strategy for Benign Esophageal Strictures: a Randomized Controlled Trial

A randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation compared to conservative esophageal dilation in patients with severe benign esophageal strictures.

A randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation (up to 6mm) compared to esophageal dilation according to the rule-of-3 in patients with severe benign esophageal strictures. Patients will be followed up for 6 months. When recurrent dysphagia occurs within 6 months the patients will be dilated according to the previously allocated strategy.

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)