Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial
Progressive Esophageal Dilation for Benign 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)