Clinical trial NCT03604523: Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation
Official title: Effectiveness of Semi-rigid Savary Dilators vs. Balloon Dilators During Esophageal Dilation in the Treatment of Esophageal Dysmotility
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Dysmotility
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to procedure, but if participant fails the first procedure they are given the opportunity to crossover to the other arm for a follow up procedure.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to prospectively evaluate the most effective treatment of esophageal dysmotility that alleviates symptoms of dysphagia and improves quality of life.

Current practice uses either semi-rigid Savary dilators or balloon dilators for esophageal dilation to treat dysphagia due to esophageal dysmotility. The study aims to show which treatment method is more effective in alleviating symptoms, since there are no other treatments available. The null hypothesis is that there is no difference between the clinical benefits of each treatment.

Detailed description: Both the Savary and balloon dilators are used as routine procedure at University of Massachusetts (UMass) Medical School's academic medical center UMass Memorial Health Care (UMMHC). Gastroenterologists are required as part of their training to be familiar with both types of procedures. This study aims to definitively determine which treatment method is more effective in alleviating the symptoms of esophageal dysmotility.

The primary clinical endpoint is to assess the therapeutic efficacy of different types of dilators in an esophageal dilation procedure in patients with esophageal dysmotility. This will be evaluated through the use of the dysphagia scale (Knyrim et al, 1993). The secondary aims are to assess time to relapse, diet improvement, as well as change in quality of life. Investigators will determine time to relapse by time between the dilation procedures. Participants are instructed to contact the GI office to schedule another dilation if they feel as though the therapeutic effect of the procedure has subsided and they are in need of additional relief. Diet will be assessed using the diet score (Cox et al, 1998) and quality of life will be assessed using the Short Form (SF) SF-12 Health Survey.

If patients fail the first procedure, they can be offered the alternative procedure at a later date. Both the patient and physician must agree that the treatment has not worked, and then the patient will be given the opportunity to cross over to the other procedure, still blinded to the device that will be used. Investigators will conduct an interim evaluation to assess the progress of the study and degree of crossover. This will ensure that all subjects are given the opportunity to have both devices used in the event that one is significantly superior to the other.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Dysphagia to liquids and/or solids
* Diagnosis of esophageal dysmotility
* Normal endoscopic exam

Exclusion Criteria:

* Diagnosis of achalasia
* Defined strictures or webs
* Vulnerable populations:
* Adults unable to consent (Individuals who are not yet adults (infants, children, teenagers), Pregnant women, Prisoners)

Primary outcomes:
measure: Therapeutic Efficacy as Measured by Change in Dysphagia Scale Score
timeFrame: Baseline to 6 months post-procedure
Secondary outcomes:
measure: Participants With Relapse
timeFrame: Baseline to 6 months
measure: Time to Relapse
timeFrame: Initial intervention to second dilation
measure: Diet Dysphagia Score Change
timeFrame: baseline to 6 months post procedure
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: Professor of Medicine, UMass Medical School
name: David Cave, MD
role: PRINCIPAL_INVESTIGATOR
References: