Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Benign Esophageal Stricture

Intervention / Treatment
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* Device: Savary bougie dilation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled patient groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive<br>Patients will be dilated > 3mm and can be dilated up to 6mm in diameter | Device: Savary bougie dilation<br>* Patients will be dilated with the use of the Savary bougienage device<br>|
| Active Comparator: Conservative (rule-of-3)<br>Patients will be dilated according to the rule-of-3 (i.e. dilation of no more than 3mm in diameter) | Device: Savary bougie dilation<br>* Patients will be dilated with the use of the Savary bougienage device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of dilation procedures within 6 months of follow-up | Total number of dilation procedures within 6 months of follow-up | 6 months | 
| Total number of dilation procedures during first dilation session to 16-18mm | Total number of dilation procedures during first dilation session to 16-18mm | 1 month | 

Secondary Outcome Measures

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