Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial (NCT03192098) | Clinical Trial Compass
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Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial
Netherlands80 participantsStarted 2017-05-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Total number of dilation procedures within 6 months of follow-up
Timeframe: 6 months
2
Total number of dilation procedures during first dilation session to 16-18mm