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Endoscopic Submucosal Dissection Registry

Endoscopic Submucosal Dissection Patients Registry in Agrippa Ionescu Hospital, Bucharest, Romania

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06033976
Acronym
ESDREG
Enrollment
200
Registered
2023-09-13
Start date
2021-01-01
Completion date
2031-01-31
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm, Colorectal, Neoplasm, Duodenal, Neoplasm, Esophagus, Neoplasm, Stomach

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.

Interventions

Endoscopic injection of fluid into the gastrointestinal submucosal space followed by endoscopic knife dissection around and under the lesion so as to remove the lesion specimen in one piece with lesion free resection margins.

Sponsors

Carol Davila University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frame
Rate of curative resectionthrough study completion, an average of 1 year

Secondary

MeasureTime frame
Rate of R0 resectionthrough study completion, an average of 1 year

Other

MeasureTime frame
Rate of perforation30 days
Rate of delayed bleeding30 days

Countries

Romania

Contacts

Primary ContactCiocirlan L Mihai, Associate Professor
mihai.ciocirlan@umfcd.ro0040722322625

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026