ESDREG: Endoscopic Submucosal Dissection Registry
Sponsor
Carol Davila University of Medicine and Pharmacy (Other)
Overall Status
Recruiting
CT.gov ID
NCT06033976
Collaborator
(none)
200
1
120
1.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 [Patient Registry]
Anticipated Enrollment
:
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Endoscopic Submucosal Dissection Patients Registry in "Agrippa Ionescu" Hospital, Bucharest, Romania
Actual Study Start Date
:
Jan 1, 2021
Anticipated Primary Completion Date
:
Jan 1, 2031
Anticipated Study Completion Date
:
Jan 1, 2031
Outcome Measures
Primary Outcome Measures
- Rate of curative resection [through study completion, an average of 1 year]
Secondary Outcome Measures
- Rate of R0 resection [through study completion, an average of 1 year]
Other Outcome Measures
- Rate of perforation [30 days]
- Rate of delayed bleeding [30 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 100 Years
Sexes Eligible for Study:
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | "Agrippa Ionescu" Hospital | Bucharest | Romania |
Sponsors and Collaborators
- Carol Davila University of Medicine and Pharmacy
Investigators
- Principal Investigator: Mihai L Ciocirlan, Associate Professor, Carol Davila University of Medicine and Pharmacy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mihai Ciocirlan,
Clinical Professor (Associate Professor),
Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT06033976
Other Study ID Numbers:
- ESDREG
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: