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Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Premysl Falt MD, Vitkovice Hospital
ClinicalTrials.gov Identifier:
NCT01478919
First received: November 21, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Local Residual Neoplasia After Convetional Endoscopic Mucosal Resection of Laterally Spreading Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vitkovice Hospital:

Primary Outcome Measures:
  • Occurence of Local Residual Neoplasia (LRN) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Evaluation of Selected Risk Factors for Local Residual Neoplasia (LRN) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 127
Study Start Date: January 2010
Study Completion Date: November 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred for Endoscopic Mucosal Resection (EMR) of Laterally Spreading Tumors (LST.)

Criteria

Inclusion Criteria:

  • all consecutive patients referred for EMR of LST

Exclusion Criteria:

  • polyposis syndromes
  • previous therapeutic attempt
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478919

Locations
Czech Republic
Vitkovice Hospital
Ostrava, Czech Republic, 703 84
Sponsors and Collaborators
Vitkovice Hospital
  More Information

No publications provided

Responsible Party: Premysl Falt MD, Investigator, Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT01478919     History of Changes
Other Study ID Numbers: DDC VN 02
Study First Received: November 21, 2011
Last Updated: November 22, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Vitkovice Hospital:
Endoscopic Mucosal Resection
Laterally Spreading Tumor
Local Residual Neoplasia
Colonoscopy
Therapy

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on June 17, 2013