Benign Esophageal Stricture
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICESavary bougie dilation
Patients will be dilated with the use of the Savary bougienage device
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will be blinded for dilation strategy.
Intervention model description
randomized controlled patient groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Dysphagia free patients | 6 months | Number of patients remaining dysphagia free within 6 months after dilation to 16-18mm |
| Medical costs | 7 months | Direct medicals costs: procedures, secondary interventions |
| Quality of Life | 6 months | SF-36, disease specific questionnaire |
| Timeframe first dilation session | 1 month | Time from first dilation session to dilation of 16-18mm |
Countries
Netherlands
Contacts
Primary ContactBram Vermeulen, Drs.
Backup ContactPeter Siersema, Dr.
Outcome results
None listed