NCT06033976RecruitingNot Applicable
Endoscopic Submucosal Dissection Patients Registry in "Agrippa Ionescu" Hospital, Bucharest, Romania
Carol Davila University of Medicine and Pharmacy1 site in 1 country200 target enrollmentStarted: January 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Rate of curative resection
Study Overview
Brief Summary
This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive tract lesions treated with curative intention by endoscopic submucosal dissection (ESD) technique.
Detailed Description
Cases will be registered one by one in an electronic record, with the consent of the patient and respecting all legal requirements.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •epithelial pre-neoplastic (eg. adenoma, dysplasia) lesion on the esophageal, gastric, duodenal or colorectal mucosa
- •non-epithelial (eg. neuroendocrine tumor) lesion on the esophageal, gastric, duodenal or colorectal mucosa
- •age > 18 years old
- •informed consent
Exclusion Criteria
- •age < 18 years old
- •no informed consent
Outcomes
Primary Outcomes
Rate of curative resection
Time Frame: through study completion, an average of 1 year
Secondary Outcomes
- Rate of R0 resection(through study completion, an average of 1 year)
Investigators
Mihai Ciocirlan
Clinical Professor (Associate Professor)
Carol Davila University of Medicine and Pharmacy
Study Sites (1)
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