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Slow enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilation by Balloon | Active Comparator | Esophageal dilation by balloon device. |
|
| Dilation by Semi-rigid Savary | Active Comparator | Esophageal dilation by semi-rigid savary device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilation by Balloon | Device | Esophageal dilation by balloon device. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Efficacy as Measured by Change in Dysphagia Scale Score | 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. | Baseline to 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Relapse | Participants who required esophageal dilation within time frame | Baseline to 6 months |
| Time to Relapse | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Cave, MD | Professor of Medicine, UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dilation by Balloon | Esophageal dilation by balloon device. Dilation by Balloon: Esophageal dilation by balloon device. |
| FG001 | Dilation by Semi-rigid Savary | Esophageal dilation by semi-rigid savary device. Dilation by Semi-rigid Savary: Esophageal dilation by semi-rigid savary device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dilation by Balloon | Esophageal dilation by balloon device. Dilation by Balloon: Esophageal dilation by balloon device. |
| BG001 | Dilation by Semi-rigid Savary | Esophageal dilation by semi-rigid savary device. Dilation by Semi-rigid Savary: Esophageal dilation by semi-rigid savary device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Therapeutic Efficacy as Measured by Change in Dysphagia Scale Score | 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. | Data missing from participants who were lost to follow up at 6 months. Data provided for participants who completed 6 month follow up dysphagia score assessment. | Posted | Mean | Full Range | units on a scale | Baseline to 6 months post-procedure |
|
Baseline to 6 months after procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dilation by Balloon | Esophageal dilation by balloon device. Dilation by Balloon: Esophageal dilation by balloon device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
Recruitment was much slower than planned and the study was terminated early with only 15.6% of overall study goal enrolled. Early termination led to small numbers of subjects analyzed. Subjects unable to be reached for followup led to missing data for outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Cave | UMass Medical School | 508-856-8399 | david.cave@umassmemorial.org |
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| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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.
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| Dilation by Semi-rigid Savary |
| Device |
Esophageal dilation by semi-rigid savary device |
|
| Initial intervention to second dilation |
| Diet Dysphagia Score Change | 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 | baseline to 6 months post procedure |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Dilation by Semi-rigid Savary | Esophageal dilation by semi-rigid savary device. Dilation by Semi-rigid Savary: Esophageal dilation by semi-rigid savary device |
|
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| Secondary | Participants With Relapse | Participants who required esophageal dilation within time frame | The population of those who were enrolled in the arms and received the assigned intervention. | Posted | Count of Participants | Participants | Baseline to 6 months |
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|
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| Secondary | Time to Relapse | 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. | Participants who experienced a relapse in time period from baseline to 6 months. Only 2 participants in the dilation by balloon group experienced a relapse. This population was used to calculate the time to relapse. No participants in the dilation by semi-rigid Savary experienced a relapse during this time. | Posted | Mean | Full Range | days | Initial intervention to second dilation |
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|
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| Secondary | Diet Dysphagia Score Change | 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 | Data is incomplete. Only 1 participant provided full diet score survey at 6 months. | Posted | Number | units on a scale | baseline to 6 months post procedure |
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| 0 |
| 4 |
| 1 |
| 4 |
| 4 |
| 4 |
| EG001 | Dilation by Semi-rigid Savary | Esophageal dilation by semi-rigid savary device. Dilation by Semi-rigid Savary: Esophageal dilation by semi-rigid savary device | 0 | 5 | 1 | 5 | 5 | 5 |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Chest pain | General disorders | Non-systematic Assessment |
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| Leg cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
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