Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

Recruitment & Eligibility

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)

Study & Design

Arm && Interventions

Group	Intervention	Description
Progressive	Savary bougie dilation	Patients will be dilated \> 3mm and can be dilated up to 6mm in diameter
Conservative (rule-of-3)	Savary bougie dilation	Patients will be dilated according to the rule-of-3 (i.e. dilation of no more than 3mm in diameter)

Primary Outcome Measures

Name	Time	Method
Total number of dilation procedures within 6 months of follow-up	6 months	Total number of dilation procedures within 6 months of follow-up
Total number of dilation procedures during first dilation session to 16-18mm	1 month	Total number of dilation procedures during first dilation session to 16-18mm

Secondary Outcome Measures

Name	Time	Method
Dysphagia free patients	6 months	Number of patients remaining dysphagia free within 6 months after dilation to 16-18mm
Timeframe first dilation session	1 month	Time from first dilation session to dilation of 16-18mm
Dysphagia free time period	6 months	Time to dilation of recurrent stricture after initial dilation to 16-18mm
Incidence of treatment-related mortality (serious) adverse events (safety)	7 months	Incidence of treatment-related mortality (serious) adverse events (safety)
Quality of Life	6 months	SF-36, disease specific questionnaire
Medical costs	7 months	Direct medicals costs: procedures, secondary interventions

Recruitment & Eligibility