Trial Outcomes & Findings for Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy (NCT NCT02069847)

Results Overview

Number of subjects with Non-dysplastic, low grade dysplasia, high grade dysplasia and T1a early esophageal adenocarcinoma. As measured by using the BE dysplasia grading system of Non-dysplastic (no cancerous tissue present), low-grade dysplasia (minor cell changes found), high-grade dysplasia (extensive cell changes found, but not yet cancer), and noninvasive cancer (T1a early esophageal adenocarcinoma)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

3 months

Results posted on

2020-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Esophageal Stricture, Budesonide Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) Budesonide: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply. The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup. Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide.	Control Group Retrospective collect data for subjects who undergo endoscopic submucosal dissection or endoscopic mucosal resection
Overall Study STARTED	22	68
Overall Study COMPLETED	22	68
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esophageal Stricture, Budesonide n=22 Participants Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection or endoscopic mucosal resection Budesonide: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply. The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup. Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide.	Control Group n=68 Participants Retrospective collect data for subjects who undergo endoscopic submucosal dissection or endoscopic mucosal resection	Total n=90 Participants Total of all reporting groups
Age, Continuous	72.7 years STANDARD_DEVIATION 10.6 • n=22 Participants	67.9 years STANDARD_DEVIATION 10.3 • n=68 Participants	70.2 years STANDARD_DEVIATION 10.3 • n=90 Participants
Sex: Female, Male Female	4 Participants n=22 Participants	10 Participants n=68 Participants	14 Participants n=90 Participants
Sex: Female, Male Male	18 Participants n=22 Participants	58 Participants n=68 Participants	76 Participants n=90 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	22 participants n=22 Participants	68 participants n=68 Participants	90 participants n=90 Participants

PRIMARY outcome

Timeframe: 3 months

Number of subjects with Non-dysplastic, low grade dysplasia, high grade dysplasia and T1a early esophageal adenocarcinoma. As measured by using the BE dysplasia grading system of Non-dysplastic (no cancerous tissue present), low-grade dysplasia (minor cell changes found), high-grade dysplasia (extensive cell changes found, but not yet cancer), and noninvasive cancer (T1a early esophageal adenocarcinoma)

Outcome measures

Outcome measures
Measure	Esophageal Stricture, Budesonide n=22 Participants Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection or endoscopic mucosal resection Budesonide: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply. The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup. Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide.	Control Group n=68 Participants Retrospective collect data for subjects who undergo endoscopic submucosal dissection or endoscopic mucosal resection
Dysplasia in Barrett Esophagus (BE) High grade dysplasia BE	6 Participants	20 Participants
Dysplasia in Barrett Esophagus (BE) T1a early esophageal adenocarcinoma	9 Participants	20 Participants
Dysplasia in Barrett Esophagus (BE) Non-dysplastic BE	4 Participants	4 Participants
Dysplasia in Barrett Esophagus (BE) Low grade dysplasia BE	3 Participants	23 Participants

SECONDARY outcome

Timeframe: 3 months

Number of subjects with 50-74%, 75-99% and 100% esophageal stricture. Defined as the percentage of esophageal lumen narrowing requiring dilation prior to passage of the endoscope and/or presence of new dysphagia.

Outcome measures

Outcome measures
Measure	Esophageal Stricture, Budesonide n=22 Participants Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection or endoscopic mucosal resection Budesonide: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply. The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup. Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide.	Control Group n=68 Participants Retrospective collect data for subjects who undergo endoscopic submucosal dissection or endoscopic mucosal resection
Rate of Esophageal Stricture 50-74% esophageal stricture	1 Participants	9 Participants
Rate of Esophageal Stricture 75-99% esophageal stricture	0 Participants	6 Participants
Rate of Esophageal Stricture 100% esophageal stricture	3 Participants	0 Participants

Adverse Events

Esophageal Stricture, Budesonide

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Esophageal Stricture, Budesonide n=22 participants at risk Budesonide 1mg twice a day for a total of 8 weeks following endoscopic submucosal dissection or endoscopic mucosal resection Budesonide: Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply. The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup. Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide.
Gastrointestinal disorders Dilation	18.2% 4/22 • Number of events 4 • Adverse events were only collected on the prospective arm of the study, the Budesonide treatment arm and not available for the retrospective chart review of the control arm. Adverse events were collected for each subject from enrollment until 12 week follow up, for an overall study duration of approximately 3 years.
Gastrointestinal disorders Dysphagia	31.8% 7/22 • Number of events 7 • Adverse events were only collected on the prospective arm of the study, the Budesonide treatment arm and not available for the retrospective chart review of the control arm. Adverse events were collected for each subject from enrollment until 12 week follow up, for an overall study duration of approximately 3 years.

Additional Information

Michael B. Wallace

Mayo Clinic

Phone: 507-953-2221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place