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

NCT02989818 | Recruiting

• 1 other identifier: IRB201600246
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

• Rate of en-bloc resection

  An Excision of the targeted lesion in a single specimen

  3-4 hours

Secondary Outcomes (5)

• Rate of R0 resection

  3-4 hours

• Rate of R1 resection

  3-4 hours

• Curative resection

  3-4 hours

• Rate of Adverse events with ESD

  1 month

• Rate of complete remission of neoplasia

  1 month

Study Arms (1)

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

Interventions

Endoscopic Submucosal Dissection OTHER

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

Also known as: ESD

Lesion of the Gastrointestinal tract

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (3)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 36731578 DERIVED

• 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.

  PMID: 34906544 DERIVED

• 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.

  PMID: 33610532 DERIVED

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Peter Draganov, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Draganov, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 12, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

US (3)