Barrett Esophagus, Esophageal Lesion, Gastrointestinal Lesions
Conditions
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.
Interventions
PROCEDUREEndoscopic Submucosal Dissection
Endoscopic submucosal dissection (ESD) is an outpatient procedure to remove deep tumors from the gastrointestinal (GI) tract
Sponsors
AdventHealth
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Safety- Adverse Events | 12 months | 4\) This will be measured based on the rate of adverse events with the procedure |
Countries
United States
Contacts
CONTACTDennis Yang, MD
PRINCIPAL_INVESTIGATORDennis Yang, MD
AdventHealth Orlando
Outcome results
None listed