- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06033976
Endoscopic Submucosal Dissection Registry (ESDREG)
September 10, 2023 updated by: Mihai Ciocirlan, Carol Davila University of Medicine and Pharmacy
Endoscopic Submucosal Dissection Patients Registry in "Agrippa Ionescu" Hospital, Bucharest, Romania
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ciocirlan L Mihai, Associate Professor
- Phone Number: 0040722322625
- Email: mihai.ciocirlan@umfcd.ro
Study Locations
-
-
-
Bucharest, Romania
- Recruiting
- "Agrippa Ionescu" Hospital
-
Contact:
- Mihai L Ciocirlan
- Phone Number: 0040722322625
- Email: mihai.ciocirlan@umfcd.ro
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed at or referred to Gastroenterology Clinic, University of Medicine and Pharmacy, "Agrippa Ionescu" Hospital, Bucharest, Romania
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of curative resection
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of R0 resection
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of perforation
Time Frame: 30 days
|
30 days
|
Rate of delayed bleeding
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mihai L Ciocirlan, Associate Professor, Carol Davila University of Medicine and Pharmacy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Estimated)
January 1, 2031
Study Completion (Estimated)
January 1, 2031
Study Registration Dates
First Submitted
September 3, 2023
First Submitted That Met QC Criteria
September 10, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 10, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Head and Neck Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Esophageal Diseases
- Duodenal Diseases
- Neoplasms
- Stomach Neoplasms
- Colorectal Neoplasms
- Esophageal Neoplasms
- Duodenal Neoplasms
Other Study ID Numbers
- ESDREG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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