Endoscopic Treatment for Local Residual Neoplasia

Colorectal Cancer Clinical Trial

Official title:

Endoscopic Treatment for Local Residual Neoplasia After Endoscopic Mucosal Resection of the Colorectal Lateral Spreading Tumors (LST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386618
• Other study ID #: DDC VN 07
• Status: Completed
• Phase: N/A
• First received: September 19, 2013
• Last updated: October 4, 2015
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Vitkovice Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Standardized endoscopic treatment of local residual neoplasia
Endoscopic treatment will be performed according to the type of local residual neoplasia (LRN): A - endoscopically negative scar and neoplastic tissue found only in biopsy specimens - treatment by argon plasmacoagulation, B - endoscopically aparent LRN < 5 mm - forceps biopsy + argon plasmacoagulation, C - endoscopically evident LRN > 5 mm + lifting during submucosal injection - endoscopic mucosal resectio + argon plasmacoagulation, D - endoscopically evident LRN > 5 mm + non-lifting during submucosal injection - endoscopic submucosal disection (ESD) or surgical resection

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of endoscopic treatment od local residual neoplasia (absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination)	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.	6 months	No