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

University of Florida300 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Endoscopic Submucosal Dissection

Interventions

Endoscopic Submucosal DissectionOTHER

This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (3)

University of Florida

Gainesville, Florida, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Rate of en-bloc resection

An Excision of the targeted lesion in a single specimen

Time frame: 3-4 hours

Secondary Outcomes

Rate of R0 resection

when all vertical and horizontal margins are negative

Time frame: 3-4 hours

Rate of R1 resection

complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins

Time frame: 3-4 hours

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

Time frame: 3-4 hours

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)

Time frame: 1 month

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

Time frame: 1 month

Central Contacts

Peter Draganov, MD

CONTACT

352-273-9472 peter.draganov@medicine.ufl.edu

Data from ClinicalTrials.gov

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