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

Recruiting

• Conditions: Endoscopic Submucosal Dissection
• Interventions: Other: Endoscopic Submucosal Dissection

• Registration Number: NCT02989818
• Lead Sponsor: University of Florida

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• a. Age 18 years or older.
• b. Scheduled to undergo ESD as part of their standard of care.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lesion of the Gastrointestinal tract	Endoscopic Submucosal Dissection	Investigator will collect prospective data on the Endoscopic Submucosal dissection that is used as part of the subjects standard of care to remove the Gastrointestinal lesion

Primary Outcome Measures

Name	Time	Method
Rate of en-bloc resection	3-4 hours	An Excision of the targeted lesion in a single specimen

Secondary Outcome Measures

Name	Time	Method
Rate of R1 resection	3-4 hours	complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins
Rate of Adverse events with ESD	1 month	Early (\<48 hours) and late (\>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)
Curative resection	3-4 hours	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
Rate of complete remission of neoplasia	1 month	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
Rate of R0 resection	3-4 hours	when all vertical and horizontal margins are negative

Trial Locations

Locations (3)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States