An observational study in Neoplasm, Stomach, Neoplasm, Colorectal and Neoplasm, Esophagus, sponsored by Carol Davila University of Medicine and Pharmacy. Recruiting at 1 site in Romania. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Carol Davila University of Medicine and Pharmacy · Observational
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.
Cases will be registered one by one in an electronic record, with the consent of the patient and respecting all legal requirements.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 200 is below the median of 278 across 790 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Carol Davila University of Medicine and Pharmacy is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed at or referred to Gastroenterology Clinic, University of Medicine and Pharmacy, "Agrippa Ionescu" Hospital, Bucharest, Romania
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: ESD
Rate of curative resection
Time frame: through study completion, an average of 1 year
Rate of R0 resection
Time frame: through study completion, an average of 1 year
Rate of perforation
Time frame: 30 days
Rate of delayed bleeding
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Jan 2031, 120 months after the start.
Of 322 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's planned 120 months is above that.
Counting every sponsor, half of 364 studies reached it within 54 months; a quarter within 29 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Carol Davila University of Medicine and Pharmacy