Clinical trial NCT03192098: Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial
Official title: Progressive Versus Conservative Dilation Strategy for Benign Esophageal Strictures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Esophageal Stricture
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled patient groups
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total number of dilation procedures within 6 months of follow-up
timeFrame: 6 months
measure: Total number of dilation procedures during first dilation session to 16-18mm
timeFrame: 1 month
Secondary outcomes:
measure: Dysphagia free patients
timeFrame: 6 months
measure: Timeframe first dilation session
timeFrame: 1 month
measure: Dysphagia free time period
timeFrame: 6 months
measure: Incidence of treatment-related mortality (serious) adverse events (safety)
timeFrame: 7 months
measure: Quality of Life
timeFrame: 6 months
measure: Medical costs
timeFrame: 7 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: