Endoscopic Submucosal Dissection (ESD) (ESD)

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

This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic submucosal dissection. All patients will receive standard of medical care and no experimental interventions will be performed.

Study Overview

• Status: Recruiting
• Conditions: Barrett Esophagus; Esophageal Lesion; Gastrointestinal Lesions
• Intervention / Treatment: Procedure: Endoscopic Submucosal Dissection

Detailed Description

The technique of Endoscopic Mucosal Resection (EMR) is currently widely used in the US to remove precancerous or cancerous lesions confined to the mucosa of the GI tract. EMR carries lower morbidity and mortality compare to surgery, at the expense of a higher rate of piecemeal removal, incomplete resection and cancer recurrence. Endoscopic Submucosal Dissection (ESD) is a newer technique developed in Japan that involves en-bloc resection of the entire lesion irrespective of size, allowing for a detailed analysis of the resected margins and depth of invasion and producing a lower local recurrence. Due to the lack of dedicated ESD devices the procedure has not been disseminated in Western countries. Recently the Food and Drug Administration (FDA) approved a number of devices for ESD. The vast majority of studies evaluating the clinical outcomes from ESD are originating in Japan where the technique is mostly applied to patients with early gastric cancer (Japan has the highest incidence of gastric cancer in the word). In the US lesions that are currently treated with EMR are mostly located in the esophagus (Barrett esophagus) and colon (large adenomatous polyps and intramucosal cancer). These esophageal and colonic lesions can be treated with ESD with expected higher rate of en-block resection and lower recurrence rate compare to EMR. With the differences in patient population and disease location one can anticipate some differences in outcomes between ESD performed in Asian and US patients. Therefore, the investigator wants to prospectively record the experience with ESD done as part of routine medical care in United States (US) population. This will be a prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Dennis Yang, MD; Phone Number: 407-303-2570; Email: Dennis.Yang.MD@adventhealth.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Recruiting
      • AdventHealth Orlando
      • Contact: Dennis Yang, MD; Phone Number: 407-303-2570; Email: Dennis.Yang.MD@adventhealth.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the Center of Interventional Endoscopy for standard of care ESD procedure.

Description

Inclusion Criteria:

• Age 18 years or older
• Scheduled to undergo ESD

Exclusion Criteria:

• Any contraindication to performing endoscopy
• Participation in another research protocol that could interfere or influence the outcomes measures of the present study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the utility of ESD for treatment of gastrointestinal lesions	The primary endpoint of this study will be the prospective evaluation of the utility of ESD for the endoscopic treatment of GI lesions.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
En-Bloc Resection Rate	1)This is the proportion of lesions that are resected en-bloc (in one piece) using ESD	6 months
Complete Resection Rate	2) This is the proportion of lesions that are completely resected (clean lateral and deep resection margins) with ESD.	6 months
Curative Resection Rate	3) This is the proportion of lesions that are considered to have been cured based on endoscopic and histological criteria	6 months
Safety- Adverse Events	4) This will be measured based on the rate of adverse events with the procedure	12 months

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Dennis Yang, MD, AdventHealth Orlando

Publications and helpful links

General Publications

• Kotzev AI, Yang D, Draganov PV. How to master endoscopic submucosal dissection in the USA. Dig Endosc. 2019 Jan;31(1):94-100. doi: 10.1111/den.13240. Epub 2018 Aug 22.
• Yang D, Wagh MS, Draganov PV. The status of training in new technologies in advanced endoscopy: from defining competence to credentialing and privileging. Gastrointest Endosc. 2020 Nov;92(5):1016-1025. doi: 10.1016/j.gie.2020.05.047. Epub 2020 Jun 3.
• Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Kudo SE, Tsuruta O, Sugihara KI, Watanabe T, Saitoh Y, Igarashi M, Toyonaga T, Ajioka Y, Ichinose M, Matsui T, Sugita A, Sugano K, Fujimoto K, Tajiri H. JGES guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2015 May;27(4):417-434. doi: 10.1111/den.12456. Epub 2015 Mar 5.
• Yang D, Othman M, Draganov PV. Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection For Barrett's Esophagus and Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2019 May;17(6):1019-1028. doi: 10.1016/j.cgh.2018.09.030. Epub 2018 Sep 26.
• Yang D, Draganov PV. Expanding Role of Third Space Endoscopy in the Management of Esophageal Diseases. Curr Treat Options Gastroenterol. 2018 Mar;16(1):41-57. doi: 10.1007/s11938-018-0169-z.
• Fuccio L, Hassan C, Ponchon T, Mandolesi D, Farioli A, Cucchetti A, Frazzoni L, Bhandari P, Bellisario C, Bazzoli F, Repici A. Clinical outcomes after endoscopic submucosal dissection for colorectal neoplasia: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Jul;86(1):74-86.e17. doi: 10.1016/j.gie.2017.02.024. Epub 2017 Feb 28.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus; 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: 1798539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No