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: September 19, 2013
Last verified: September 2013

November 21, 2011
September 19, 2013
January 2010
December 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01478919 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Colorectal Cancer
Not Provided
Not Provided
Urban O, Kijonkova B, Kajzrlikova IM, Vitek P, Kliment M, Fojtik P, Falt P, Reiterova K, Horava V Jr. Local residual neoplasia after endoscopic treatment of laterally spreading tumors during 15 months of follow-up. Eur J Gastroenterol Hepatol. 2013 Jun;25(6):733-8. doi: 10.1097/MEG.0b013e32835eda96.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
November 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all consecutive patients referred for EMR of LST

Exclusion Criteria:

  • polyposis syndromes
  • previous therapeutic attempt
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01478919
DDC VN 02
No
Premysl Falt MD, Vitkovice Hospital
Vitkovice Hospital
Not Provided
Not Provided
Vitkovice Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP