NCT05468008

Endoscopic Submucosal Dissection (ESD)

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Lesion
• Barrett Esophagus
• Gastrointestinal Lesions

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Submucosal Dissection	Endoscopic submucosal dissection (ESD) is an outpatient procedure to remove deep tumors from the gastrointestinal (GI) tract

Timeline

• Start date: 2022-02-04
• Primary completion: 2027-02-01
• Completion: 2027-12-01
• First posted: 2022-07-21
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States