Endoscopic Submucosal Dissection (ESD)

Recruiting

• Conditions: Esophageal Lesion; Barrett Esophagus; Gastrointestinal Lesions

• Registration Number: NCT05468008
• Lead Sponsor: AdventHealth

Brief Summary

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.

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 Timeline

• Study Start: 2022-02-04
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2027-02
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States