Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation
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|ClinicalTrials.gov Identifier: NCT03604523|
Recruitment Status : Terminated (Slow enrollment)
First Posted : July 27, 2018
Results First Posted : April 13, 2021
Last Update Posted : April 13, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Dysmotility||Device: Dilation by Balloon Device: Dilation by Semi-rigid Savary||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Official Title:||Effectiveness of Semi-rigid Savary Dilators vs. Balloon Dilators During Esophageal Dilation in the Treatment of Esophageal Dysmotility|
|Actual Study Start Date :||August 14, 2014|
|Actual Primary Completion Date :||November 26, 2016|
|Actual Study Completion Date :||November 26, 2016|
Active Comparator: Dilation by Balloon
Esophageal dilation by balloon device.
Device: Dilation by Balloon
Esophageal dilation by balloon device.
Active Comparator: Dilation by Semi-rigid Savary
Esophageal dilation by semi-rigid savary device.
Device: Dilation by Semi-rigid Savary
Esophageal dilation by semi-rigid savary device
- Therapeutic Efficacy as Measured by Change in Dysphagia Scale Score [ Time Frame: Baseline to 6 months post-procedure ]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 1993). Minimum score is 0. Maximum score is 4. Higher scores indicate a worse outcome. The data presented represent a change from baseline to 6 months calculated as the value at 6 months minus the value at baseline.
- Participants With Relapse [ Time Frame: Baseline to 6 months ]Participants who required esophageal dilation within time frame
- Time to Relapse [ Time Frame: Initial intervention to second dilation ]For the participants who relapsed, measure of time to relapse based on time from procedure to need for additional dilation due to subsidence of therapeutic effect of procedure.
- Diet Dysphagia Score Change [ Time Frame: baseline to 6 months post procedure ]Diet dysphagia score change based on change to Cox diet score, taken from Table 1 of publication Gut, 1988, 29, 1741-1747. The scores are determined based on the foods that cause dysphagia. The minimum value on the score is 0 (no dysphagia), followed by 1 (dysphagia with meat), 2 (dysphagia with bread), 3 (dysphagia with semi-solids), 4 (dysphagia with liquids), and the maximum score is 5 (total dysphagia). A higher score indicates a worse clinical outcome. The data presented represent a change from baseline to 6 months calculated as the value at 6 months minus the value at baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604523
|United States, Massachusetts|
|UMass Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||David Cave, MD||Professor of Medicine, UMass Medical School|