Trial Outcomes & Findings for Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management (NCT NCT03738566)
NCT ID: NCT03738566
Last Updated: 2023-05-24
Results Overview
Number of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
6 months following serial dilation
Results posted on
2023-05-24
Participant Flow
6 subjects randomized to self-dilation group and 6 subjects randomized to standard of care with repeat endoscopy and dilations as needed at symptoms recurrence. 5 subjects from the standard of care group crossed over to receive self-dilation because they were considered treatment failures due to requiring 2 endoscopic dilation after 3 months of study participation. 14 subjects choose not to participate in the randomized trial, but did agree to be followed in a prospective observational group.
Participant milestones
| Measure |
Standard Clinical Care Endoscopic Dilation Group
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Esophageal Self-Dilation Therapy (ESDT) Group
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
|
Observational Study Group
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Standard Clinical Care Endoscopic Dilation, Then ESDT
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
|---|---|---|---|---|
|
Initial Study Phase
STARTED
|
6
|
6
|
14
|
0
|
|
Initial Study Phase
COMPLETED
|
0
|
4
|
12
|
0
|
|
Initial Study Phase
NOT COMPLETED
|
6
|
2
|
2
|
0
|
|
Cross-over for Treatment Failure
STARTED
|
0
|
0
|
0
|
5
|
|
Cross-over for Treatment Failure
COMPLETED
|
0
|
0
|
0
|
4
|
|
Cross-over for Treatment Failure
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Standard Clinical Care Endoscopic Dilation Group
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Esophageal Self-Dilation Therapy (ESDT) Group
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
|
Observational Study Group
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Standard Clinical Care Endoscopic Dilation, Then ESDT
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
|---|---|---|---|---|
|
Initial Study Phase
Withdrawal by Subject
|
1
|
1
|
2
|
0
|
|
Initial Study Phase
Death
|
0
|
1
|
0
|
0
|
|
Initial Study Phase
Treatment failure
|
5
|
0
|
0
|
0
|
|
Cross-over for Treatment Failure
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Data are reported separately for the initial phase and cross over phase. Data was not collected in the initial study phase for the Standard Clinical Care Endoscopic Dilation, Then ESDT group. Data was not collected in the cross-over for Treatment Failure phase for Standard Clinical Care Endoscopic Dilation Group, Esophageal Self-Dilation Therapy (ESDT) Group, or Observational Study Group as these groups were only part of the initial study phase.
Baseline characteristics by cohort
| Measure |
Standard Clinical Care Endoscopic Dilation Group
n=6 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Esophageal Self-Dilation Therapy (ESDT) Group
n=6 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
|
Observational Study Group
n=14 Participants
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Standard Clinical Care Endoscopic Dilation, Then ESDT
n=5 Participants
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Initial Study Phase
|
64.0 years
STANDARD_DEVIATION 11.0 • n=6 Participants • Data are reported separately for the initial phase and cross over phase. Data was not collected in the initial study phase for the Standard Clinical Care Endoscopic Dilation, Then ESDT group. Data was not collected in the cross-over for Treatment Failure phase for Standard Clinical Care Endoscopic Dilation Group, Esophageal Self-Dilation Therapy (ESDT) Group, or Observational Study Group as these groups were only part of the initial study phase.
|
62.3 years
STANDARD_DEVIATION 9.6 • n=6 Participants • Data are reported separately for the initial phase and cross over phase. Data was not collected in the initial study phase for the Standard Clinical Care Endoscopic Dilation, Then ESDT group. Data was not collected in the cross-over for Treatment Failure phase for Standard Clinical Care Endoscopic Dilation Group, Esophageal Self-Dilation Therapy (ESDT) Group, or Observational Study Group as these groups were only part of the initial study phase.
|
62 years
STANDARD_DEVIATION 15 • n=14 Participants • Data are reported separately for the initial phase and cross over phase. Data was not collected in the initial study phase for the Standard Clinical Care Endoscopic Dilation, Then ESDT group. Data was not collected in the cross-over for Treatment Failure phase for Standard Clinical Care Endoscopic Dilation Group, Esophageal Self-Dilation Therapy (ESDT) Group, or Observational Study Group as these groups were only part of the initial study phase.
|
—
|
62.9 years
STANDARD_DEVIATION 12.3 • n=26 Participants • Data are reported separately for the initial phase and cross over phase. Data was not collected in the initial study phase for the Standard Clinical Care Endoscopic Dilation, Then ESDT group. Data was not collected in the cross-over for Treatment Failure phase for Standard Clinical Care Endoscopic Dilation Group, Esophageal Self-Dilation Therapy (ESDT) Group, or Observational Study Group as these groups were only part of the initial study phase.
|
|
Age, Continuous
Cross-over for Treatment Failure
|
—
|
—
|
—
|
65 years
STANDARD_DEVIATION 7 • n=5 Participants • Data are reported separately for the initial phase and cross over phase. Data was not collected in the initial study phase for the Standard Clinical Care Endoscopic Dilation, Then ESDT group. Data was not collected in the cross-over for Treatment Failure phase for Standard Clinical Care Endoscopic Dilation Group, Esophageal Self-Dilation Therapy (ESDT) Group, or Observational Study Group as these groups were only part of the initial study phase.
|
65 years
STANDARD_DEVIATION 7 • n=5 Participants • Data are reported separately for the initial phase and cross over phase. Data was not collected in the initial study phase for the Standard Clinical Care Endoscopic Dilation, Then ESDT group. Data was not collected in the cross-over for Treatment Failure phase for Standard Clinical Care Endoscopic Dilation Group, Esophageal Self-Dilation Therapy (ESDT) Group, or Observational Study Group as these groups were only part of the initial study phase.
|
|
Sex: Female, Male
Initial Study Phase · Female
|
3 Participants
n=6 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
4 Participants
n=6 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
7 Participants
n=14 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
0 Participants
Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
14 Participants
n=26 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
|
Sex: Female, Male
Initial Study Phase · Male
|
3 Participants
n=6 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
2 Participants
n=6 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
7 Participants
n=14 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
0 Participants
Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
12 Participants
n=26 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
|
Sex: Female, Male
Cross-over for Treatment Failure · Female
|
0 Participants
Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
0 Participants
Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
0 Participants
Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
3 Participants
n=5 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
3 Participants
n=5 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
|
Sex: Female, Male
Cross-over for Treatment Failure · Male
|
0 Participants
Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
0 Participants
Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
0 Participants
Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
2 Participants
n=5 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
2 Participants
n=5 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
6 participants
n=6 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
14 participants
n=14 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
5 participants
n=5 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
5 participants
n=5 Participants • Data collected from the cross over study group are being reported separately to avoid multi-counted participants.
|
PRIMARY outcome
Timeframe: 6 months following serial dilationNumber of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care
Outcome measures
| Measure |
Standard Clinical Care Endoscopic Dilation Group
n=5 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Esophageal Self-Dilation Therapy (ESDT) Group
n=6 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
|
Observational Study Group
n=14 Participants
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Standard Clinical Care Endoscopic Dilation, Then ESDT
n=4 Participants
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
|---|---|---|---|---|
|
Number of Endoscopic Interventions
|
12 endoscopies
|
11 endoscopies
|
12 endoscopies
|
7 endoscopies
|
SECONDARY outcome
Timeframe: 6 monthsNumber of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia
Outcome measures
| Measure |
Standard Clinical Care Endoscopic Dilation Group
n=5 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Esophageal Self-Dilation Therapy (ESDT) Group
n=6 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
|
Observational Study Group
n=14 Participants
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Standard Clinical Care Endoscopic Dilation, Then ESDT
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
|---|---|---|---|---|
|
Length of Days Intervention Free
|
7 days
Interval 2.0 to 33.0
|
82 days
Interval 39.0 to 124.0
|
147 days
Interval 113.5 to 166.5
|
—
|
SECONDARY outcome
Timeframe: BaselineThe MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"
Outcome measures
| Measure |
Standard Clinical Care Endoscopic Dilation Group
n=6 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Esophageal Self-Dilation Therapy (ESDT) Group
n=6 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
|
Observational Study Group
n=14 Participants
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Standard Clinical Care Endoscopic Dilation, Then ESDT
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
|---|---|---|---|---|
|
Mayo Dysphagia Questionnaire (MDQ-30) at Baseline
|
7.16 score on a scale
Standard Deviation 1.16
|
7.56 score on a scale
Standard Deviation 1.44
|
5.36 score on a scale
Standard Deviation 2.17
|
—
|
SECONDARY outcome
Timeframe: 12 monthsThe MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"
Outcome measures
| Measure |
Standard Clinical Care Endoscopic Dilation Group
n=4 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Esophageal Self-Dilation Therapy (ESDT) Group
n=12 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
|
Observational Study Group
n=4 Participants
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Standard Clinical Care Endoscopic Dilation, Then ESDT
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
|---|---|---|---|---|
|
Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months
|
5.55 score on a scale
Standard Deviation 2.07
|
5.83 score on a scale
Standard Deviation 3.60
|
5.17 score on a scale
Standard Deviation 2.04
|
—
|
SECONDARY outcome
Timeframe: 12 monthsNumber of clinically significant adverse events including perforation, bleeding and pain
Outcome measures
| Measure |
Standard Clinical Care Endoscopic Dilation Group
n=6 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Esophageal Self-Dilation Therapy (ESDT) Group
n=6 Participants
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
|
Observational Study Group
n=14 Participants
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Standard Clinical Care Endoscopic Dilation, Then ESDT
n=5 Participants
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
|---|---|---|---|---|
|
Clinically Significant Adverse Events
|
0 events
|
0 events
|
0 events
|
1 events
|
Adverse Events
Standard Clinical Care Endoscopic Dilation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Esophageal Self-Dilation Therapy (ESDT) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Observational Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Clinical Care Endoscopic Dilation, Then ESDT
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Clinical Care Endoscopic Dilation Group
n=6 participants at risk
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Esophageal Self-Dilation Therapy (ESDT) Group
n=6 participants at risk
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
|
Observational Study Group
n=14 participants at risk
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
Standard Clinical Care Endoscopic Dilation, Then ESDT
n=5 participants at risk
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Esophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
Endoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Esophageal perforation
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for a total of approximately 12 months on all participants.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for a total of approximately 12 months on all participants.
|
0.00%
0/14 • Adverse events were collected from baseline to end of study for a total of approximately 12 months on all participants.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 12 months on all participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place