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

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

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

Study Overview

• Status: Recruiting
• Conditions: Endoscopic Submucosal Dissection
• Intervention / Treatment: Other: Endoscopic Submucosal Dissection

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Peter Draganov, MD; Phone Number: 352-273-9472; Email: peter.draganov@medicine.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Principal Investigator: Peter Draganov, MD
      • Contact: Peter Draganov, MD; Phone Number: 352-273-9472; Email: peter.draganov@medicine.ufl.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated and part of their standard of care

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lesion of the Gastrointestinal tract; 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	Other: Endoscopic Submucosal Dissection; This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.; Other Names: ESD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of en-bloc resection	An Excision of the targeted lesion in a single specimen	3-4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of R0 resection	when all vertical and horizontal margins are negative	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	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	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)	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	1 month

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Peter Draganov, MD, University of Florida

Publications and helpful links

General Publications

• Yang D, King W, Aihara H, Karasik MS, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Jawaid SA, Perbtani YB, Hoffman BJ, Akki AS, Schlachterman A, Coman RM, Wang AY, Draganov PV. Effect of endoscopic submucosal dissection on histologic diagnosis in Barrett's esophagus visible neoplasia. Gastrointest Endosc. 2022 Apr;95(4):626-633. doi: 10.1016/j.gie.2021.11.046. Epub 2021 Dec 11.
• Draganov PV, Aihara H, Karasik MS, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Jawaid SA, Westerveld D, Perbtani YB, Hoffman BJ, Schlachterman A, Siegel A, Coman RM, Wang AY, Yang D. Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study. Gastroenterology. 2021 Jun;160(7):2317-2327.e2. doi: 10.1053/j.gastro.2021.02.036. Epub 2021 Feb 19.
• King W, Draganov P, Gorrepati VS, Hayat M, Aihara H, Karasik M, Ngamruengphong S, Aadam AA, Othman MO, Sharma N, Grimm IS, Rostom A, Elmunzer BJ, Yang D. Safety and feasibility of same-day discharge after endoscopic submucosal dissection: a Western multicenter prospective cohort study. Gastrointest Endosc. 2023 Jun;97(6):1045-1051. doi: 10.1016/j.gie.2023.01.042. Epub 2023 Jan 30.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimated): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Endoscopic Mucosal Resection
• Other Study ID Numbers: IRB201600246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED