Endoscopic Submucosal Dissection (ESD)

Barrett Esophagus Clinical Trial

— ESD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05468008
• Other study ID #: 1798539
• Status: Recruiting
• Start date: February 4, 2022
• Est. completion date: December 2027

Study information

• Verified date: October 2023
• Source: AdventHealth
• Contact: Dennis Yang, MD
• Phone: 407-303-2570
• Email: Dennis.Yang.MD[@]adventhealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Lesion
• Gastrointestinal Lesions

Intervention

Procedure:
• Endoscopic Submucosal Dissection
Endoscopic submucosal dissection (ESD) is an outpatient procedure to remove deep tumors from the gastrointestinal (GI) tract

Locations

Country	Name	City	State
United States	AdventHealth Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	En-Bloc Resection Rate	1)This is the proportion of lesions that are resected en-bloc (in one piece) using ESD	6 months
Secondary	Complete Resection Rate	2) This is the proportion of lesions that are completely resected (clean lateral and deep resection margins) with ESD.	6 months
Secondary	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
Secondary	Safety- Adverse Events	4) This will be measured based on the rate of adverse events with the procedure	12 months