Subepithelial Esophageal Lesions: The Mayo Clinic Experience
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-002205
Sponsor Protocol Number: 17-002205
About this study
The aims of this study are to:
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Study the history of esophageal leiomyomas in patients followed with periodic surveillance with endoscopic ultrasound.
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Determine baseline characteristics and symptoms of patients diagnosed with esophageal leiomyomas.
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Determine the transformation rate of malignancy or symptoms (if previously asymptomatic) in patients who undergo interval surveillance EUS examinations for esophageal leiomyomas.
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Determine risk factors for progression of symptoms or malignancy in patients followed with interval surveillance EUS exams for esophageal leiomyomas.
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Assess morbidity and mortality in patients followed with interval surveillance EUS examinations for esophageal leiomyomas.
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Identify malignant sub-epithelial tumors, including leiomyosarcomas, granular cell tumors, and gastrointestinal stromal tumors (GIST) to see if there was a history of benign neoplasm preceding their diagnosis.
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Evaluate symptom progression in follow up by contacting patient to complete a validated, brief questionnaire (BEDQ: Brief Esopageal Dysphagia Questionnaire).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Exclusion Criteria:
- Children less than 18
- Prior diagnosis of metastatic malignancy, regardless of location
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Karthik Ravi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available