Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection

Colorectal Cancer Clinical Trial

Official title:

Risk Factors for Local Residual Neoplasia After Convetional Endoscopic Mucosal Resection of Laterally Spreading Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478919
• Other study ID #: DDC VN 02
• Status: Completed
• Phase: N/A
• First received: November 21, 2011
• Last updated: September 19, 2013
• Start date: January 2010
• Est. completion date: November 2011

Study information

• Verified date: September 2013
• Source: Vitkovice Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: November 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all consecutive patients referred for EMR of LST

Exclusion Criteria:

• polyposis syndromes

• previous therapeutic attempt

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer

Locations

Country	Name	City	State
Czech Republic	Vitkovice Hospital	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
Vitkovice Hospital

Country where clinical trial is conducted

Czech Republic, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of Local Residual Neoplasia (LRN)	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	No
Secondary	Evaluation of Selected Risk Factors for Local Residual Neoplasia (LRN)	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	No