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NCT04484311 Clinical Trial

Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia

Colorectal Neoplasms Clinical Trial

— NC-ESD  

Official title:
Multi-center Survey on Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04484311
Other study ID # Non-Curative ESDs Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date December 2020

Study information
Verified date July 2020
Source Universidade do Porto
Contact João Santos-Antunes, MD, MSc
Phone +351917490406
Email joao.claudio.antunes@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Short and long outcomes of ESD are well described, particularly in Eastern series. However, the outcome of non-curative ESDs is scarcely reported in the west (particularly among non-gastric or submucosal lesions). Therefore, the aim of this project is to describe the European experience with non-curative ESDs, analysing all the consecutive ESDs performed in several reference centers, assessing the presence of residual lesion in the endoscopic follow-up or in the surgical specimen.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract

Exclusion Criteria:

- Patients without endoscopic follow-up or surgery will be excluded from the analysis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Portugal Hospital S. João Porto

Sponsors (1)
Lead Sponsor Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Residual neoplasia Presence of residual neoplasia after non-curative ESD 2010-2020
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