Endoscopic Submucosal Dissection Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorCarol Davila University of Medicine and Pharmacy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
age < 18 years old
no informed consent
Trial population
Patients diagnosed at or referred to Gastroenterology Clinic, University of Medicine and Pharmacy, "Agrippa Ionescu" Hospital, Bucharest, Romania
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endoscopic submucosal dissection (ESD)
Procedure/SurgeryEndoscopic 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rate of curative resection
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Rate of R0 resection
Time frame
through study completion, an average of 1 yearOther outcomes
1
Rate of perforation
Time frame
30 days2
Rate of delayed bleeding
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov