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

Radboud University Medical Center

Status: Unknown

Conditions: Benign Esophageal Stricture

Treatments: Device: Savary bougie dilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03192098

NL.60222.901.16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Progressive

Experimental group

Description:

Patients will be dilated \> 3mm and can be dilated up to 6mm in diameter

Treatment:

Device: Savary bougie dilation

Conservative (rule-of-3)

Active Comparator group

Description:

Patients will be dilated according to the rule-of-3 (i.e. dilation of no more than 3mm in diameter)

Treatment:

Device: Savary bougie dilation