Barrett Adenocarcinoma, Barretts Esophagus With High Grade Dysplasia
Conditions
Keywords
Barrett's esophagus, Endoscopic Mucosal Resection
Brief summary
This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.
Interventions
DEVICEAcell MatriStem® Surgical Matrix
Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pilot study 10 in each group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide consent * Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions * Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma
Exclusion criteria
* Pregnant women * Prior esophageal EMR or ESD in the same region * Anyone unable to provide informed consent * Medical co-morbidities precluding EGD evaluation * History of chemoradiotherapy to the neck/esophagus * Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are permissible)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of EMR Site Healing at Follow up Endoscopy | approximately 3-4 months post EMR | Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Stricture Formation at Follow up Endoscopy | approximately 3-4 months post EMR | Number of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endoscopic Submucosal Resection With Extracelluar Matrix Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time. | 1 |
| Endoscopic Submucosal Resection Standard of Care Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care. | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Endoscopic Submucosal Resection Standard of Care | Total | Endoscopic Submucosal Resection With Extracelluar Matrix |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 participants | 3 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
Completeness of EMR Site Healing at Follow up Endoscopy
Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.
Time frame: approximately 3-4 months post EMR
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Submucosal Resection With Extracelluar Matrix | Completeness of EMR Site Healing at Follow up Endoscopy | 1 Participants |
| Endoscopic Submucosal Resection Standard of Care | Completeness of EMR Site Healing at Follow up Endoscopy | 2 Participants |
Secondary
Presence of Stricture Formation at Follow up Endoscopy
Number of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy).
Time frame: approximately 3-4 months post EMR
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endoscopic Submucosal Resection With Extracelluar Matrix | Presence of Stricture Formation at Follow up Endoscopy | 0 Participants |
| Endoscopic Submucosal Resection Standard of Care | Presence of Stricture Formation at Follow up Endoscopy | 0 Participants |