Endoscopic Submucosal Dissection Registry

Neoplasm, Colorectal Clinical Trial

— ESDREG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033976
• Other study ID #: ESDREG
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: January 2031

Study information

• Verified date: September 2023
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: Ciocirlan L Mihai, Associate Professor
• Phone: 0040722322625
• Email: mihai.ciocirlan[@]umfcd.ro
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Cases will be registered one by one in an electronic record, with the consent of the patient and respecting all legal requirements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2031
• Est. primary completion date: January 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Duodenal Neoplasms
• Esophageal Neoplasms
• Neoplasm, Colorectal
• Neoplasm, Esophagus
• Neoplasm, Stomach
• Neoplasms
• Stomach Neoplasms

Intervention

Procedure:
• Endoscopic submucosal dissection (ESD)
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.

Locations

Country	Name	City	State
Romania	"Agrippa Ionescu" Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of perforation		30 days
Other	Rate of delayed bleeding		30 days
Primary	Rate of curative resection		through study completion, an average of 1 year
Secondary	Rate of R0 resection		through study completion, an average of 1 year