- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478919
Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection
September 19, 2013 updated by: Premysl Falt MD, Vitkovice Hospital
Risk Factors for Local Residual Neoplasia After Convetional Endoscopic Mucosal Resection of Laterally Spreading Tumors
Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer.
Endoscopic treatment has replaced surgery in most of the cases.
Nevertheless, after conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue.
Therefore, endoscopic follow-up and treatment are necessary.
To decrease its occurrence, the risk factors of LRN shoudl be identified.
Thereafter, in high-risk patients, other modalities of initial treatment including Endoscopic Submucosal Dissection (ESD) and surgical treatment, could be considered.
The purpose of this prospective study is to identify risk factors associated with the presence of LRN after CER of LSTs.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
127
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ostrava, Czech Republic, 703 84
- Vitkovice Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients referred for Endoscopic Mucosal Resection (EMR) of Laterally Spreading Tumors (LST.)
Description
Inclusion Criteria:
- all consecutive patients referred for EMR of LST
Exclusion Criteria:
- polyposis syndromes
- previous therapeutic attempt
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurence of Local Residual Neoplasia (LRN)
Time Frame: 3 months
|
LRN was defined as a histologically confirmed neoplastic tissue in the biopsy samples obtained from post-resection scar during follow-up colonoscopy 3 months after endoscopic resection
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Selected Risk Factors for Local Residual Neoplasia (LRN)
Time Frame: 3 months
|
Evaluation of selected patient- and lesion-related risk factors associated with LRN (gender, age, lesion size, location, morphology, pit pattern, histology, type of resection, and others)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
November 21, 2011
First Submitted That Met QC Criteria
November 22, 2011
First Posted (Estimate)
November 23, 2011
Study Record Updates
Last Update Posted (Estimate)
September 20, 2013
Last Update Submitted That Met QC Criteria
September 19, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DDC VN 02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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