Multi-center Evaluation of the Clinical Utility of ESD in the Western Population

Endoscopic Submucosal Dissection Clinical Trial

Official title:

Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02989818
• Other study ID #: IRB201600246
• Status: Recruiting
• Start date: March 2016
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: Peter Draganov, MD
• Phone: 352-273-9472
• Email: peter.draganov[@]medicine.ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this multi-center study is to prospectively document the clinical utility of ESD.

Description:

Multi-center prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

All patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated will be considered for the study. Patients in whom ESD is considered as part of their standard medical care will be offered to participate in this study. The physician performing the procedure will also discuss the study with the subjects. If the patient agrees to participate, he or she will be given the informed consent form and allowed enough time to read it. Opportunity to ask questions will be provided. If the patient agrees to participate, he or she will sign the consent form and a copy will be provided. Data will be prospectively recorded according to the data collection form. ESD will be performed as medically indicated. The investigators from each respective center on this project will also be in charge of the medical care of the patients enrolled in the study. Follow-up will be carried out as medically indicated and no additional studies or clinic visits will be needed specifically for the purpose of this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• a. Age 18 years or older.

• b. Scheduled to undergo ESD as part of their standard of care.

Exclusion Criteria:

• a. Any contraindication to performing endoscopy.

• b. Participation in another research protocol that could interfere or influence the outcome measures of the present study.

• c. Patient is unable/unwilling to provide informed consent.

Related Conditions & MeSH terms

• Endoscopic Submucosal Dissection

Intervention

Other:
• Endoscopic Submucosal Dissection
This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Florida	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of en-bloc resection	An Excision of the targeted lesion in a single specimen	3-4 hours
Secondary	Rate of R0 resection	when all vertical and horizontal margins are negative	3-4 hours
Secondary	Rate of R1 resection	complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins	3-4 hours
Secondary	Curative resection	this will have the following: R0 resection, Well to moderately differentiated histology, Absence of Lymphovascular invasion, Absence of budding, Absence of invasion beyond superficial submucosa	3-4 hours
Secondary	Rate of Adverse events with ESD	Early (<48 hours) and late (>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)	1 month
Secondary	Rate of complete remission of neoplasia	Absence of a visible lesion and/or absence of the neoplastic lesion on biopsy specimens (histopathology) obtained from the ESD site on follow up evaluations	1 month