Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02989818

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Endoscopic Submucosal Dissection

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, Gainesville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Submucosal Dissection

Other

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

Other names: ESD

Primary outcomes

  1. Rate of en-bloc resection

    Time frame: 3-4 hours

    An Excision of the targeted lesion in a single specimen

Secondary outcomes

  1. Rate of R0 resection

    Time frame: 3-4 hours

    when all vertical and horizontal margins are negative

  2. Rate of R1 resection

    Time frame: 3-4 hours

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

  3. Curative resection

    Time frame: 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

  4. Rate of Adverse events with ESD

    Time frame: 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)

  5. Rate of complete remission of neoplasia

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Draganov, MD

CONTACT

[email protected]

352-273-9472

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2016
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.