Trial Outcomes & Findings for The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus (NCT NCT03193216)
NCT ID: NCT03193216
Last Updated: 2023-03-08
Results Overview
To compare the percentage of patients who achieved complete endoscopic eradication of dysplastic Barrett's Esophagus(BE) and non-dysplastic BE with the combination of PPI and liquid alginate solution vs. those treated with PPI alone within eighteen months from the start of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
18 months
Results posted on
2023-03-08
Participant Flow
This study had two groups. An active group with participants receiving alginate along with EET treatment and a historical control group comprised of a historical cohort of patients with dysplastic Barrett's esophagus who had EET treatment from 2017 to 2020. All patients in the historical group were treated by the same expert endoscopists included in the study and were on twice a day PPI therapy alone. Patients were matched by age, race, and length of BE.
Participant milestones
| Measure |
Alginate Group
Patients in this group will be taking the study medication -- alginate solution in addition to standard of care twice daily proton pump inhibitor therapy
Alginates: Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.
|
Historical Control Group
A control group comprised of a historical cohort of patients with dysplastic Barrett's esophagus undergoing EET treatment from 2017 to 2020 were collected.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
|
Overall Study
COMPLETED
|
14
|
21
|
|
Overall Study
NOT COMPLETED
|
10
|
0
|
Reasons for withdrawal
| Measure |
Alginate Group
Patients in this group will be taking the study medication -- alginate solution in addition to standard of care twice daily proton pump inhibitor therapy
Alginates: Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.
|
Historical Control Group
A control group comprised of a historical cohort of patients with dysplastic Barrett's esophagus undergoing EET treatment from 2017 to 2020 were collected.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Physician Decision
|
4
|
0
|
Baseline Characteristics
The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus
Baseline characteristics by cohort
| Measure |
Alginate Group
n=24 Participants
Patients in this group will be taking the study medication -- alginate solution in addition to standard of care twice daily proton pump inhibitor therapy
Alginates: Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.
|
Historical Control Group
n=21 Participants
A control group comprised of a historical cohort of patients with dysplastic Barrett's esophagus undergoing EET treatment from 2017 to 2020 were collected.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
61.1 years
n=5 Participants
|
64.9 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsTo compare the percentage of patients who achieved complete endoscopic eradication of dysplastic Barrett's Esophagus(BE) and non-dysplastic BE with the combination of PPI and liquid alginate solution vs. those treated with PPI alone within eighteen months from the start of treatment.
Outcome measures
| Measure |
Alginate Group
n=14 Participants
Patients in this group will be taking the study medication -- alginate solution in addition to standard of care twice daily proton pump inhibitor therapy
Alginates: Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.
|
Historical Control Group
n=21 Participants
A control group comprised of a historical cohort of patients with dysplastic Barrett's esophagus undergoing EET treatment from 2017 to 2020 were collected.
|
|---|---|---|
|
Percentage of Patients With Successful Eradication
Percentage of patients with eradication of dysplasia
|
45.5 percentage of participants
|
38.1 percentage of participants
|
|
Percentage of Patients With Successful Eradication
Percentage of patients with eradication of all Barretts (dysplasic and non-dysplastic)
|
36.4 percentage of participants
|
19.04 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsTo compare the number of treatment sessions required to achieve endoscopic eradication of dysplastic BE and complete eradication of all BE (dysplastic and non-dysplastic) in patients treated with the combination of PPI and liquid alginate solution vs. those treated with PPI alone.The minimum number of treatments would be 1 and maximum number of treatments in the 18 month period is 8.
Outcome measures
| Measure |
Alginate Group
n=14 Participants
Patients in this group will be taking the study medication -- alginate solution in addition to standard of care twice daily proton pump inhibitor therapy
Alginates: Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.
|
Historical Control Group
n=21 Participants
A control group comprised of a historical cohort of patients with dysplastic Barrett's esophagus undergoing EET treatment from 2017 to 2020 were collected.
|
|---|---|---|
|
Number of Treatments (Mean)
Average number of treatments to achieve eradication of all Barrett's (dysplastic and non-dysplastic)
|
3.75 number of treatment sessions
Interval 1.0 to 8.0
|
5 number of treatment sessions
Interval 1.0 to 8.0
|
|
Number of Treatments (Mean)
Average number of treatments to achieve eradication of dysplasia
|
3.1 number of treatment sessions
Interval 1.0 to 8.0
|
3.88 number of treatment sessions
Interval 1.0 to 8.0
|
Adverse Events
Alginate Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historical Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Puja Elias, Associate Professor, PI for study
Medical University of South Carolina
Phone: 8438764269
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place