Endoscopic Treatment for Local Residual Neoplasia

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Standardized endoscopic treatment of local residual neoplasia

• Registration Number: NCT02386618
• Lead Sponsor: Vitkovice Hospital

Brief Summary

Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread. According to the investigators previous study, local residual neoplasia (LRN) after conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic therapy of LRN was not sufficient in 53 % and has not been standardized yet.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-19
• Study Start: 2013-10
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-04
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• patients older than 18 years
• patients with local residual neoplasia in scar in three months after endoscopic mucosal resection for laterally spreading tumor (0-IIa > 10 mm)
• signed informed consent

Exclusion Criteria

• incomplete endoscopic mucosal resection
• previous therapy for local residual neoplasia
• difficult or impossible localization of post-EMR scar

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Local residual neoplasia	Standardized endoscopic treatment of local residual neoplasia	Patients with local residual neoplasia in 3 months after endoscopic resection of colorectal lateral spreading tumors diagnosed endoscopically and/or histologically

Primary Outcome Measures

Name	Time	Method
Efficacy of endoscopic treatment od local residual neoplasia (absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination)	6 months	Efficacious endoscopic treatment is defined as absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination in 6 months after endoscopic treatment od local residual neoplasia.

Trial Locations

Locations (1)

Vitkovice Hospital; 🇨🇿 Ostrava, Czech Republic