Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/29/2018 |
| Start Date: | August 14, 2014 |
| End Date: | August 13, 2020 |
| Contact: | Anne Foley |
| Email: | IBDClinicalTrials@umassmed.edu |
Effectiveness of Semi-rigid Savary Dilators vs. Balloon Dilators During Esophageal Dilation in the Treatment of Esophageal Dysmotility
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.
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.
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.
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.
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)
We found this trial at
1
site
Click here to add this to my saved trials
