Back to resultsEndoscopic Treatment for Local Residual Neoplasia
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Standardized endoscopic treatment of local residual neoplasia
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, laterally spreading tumors, endoscopic mucosal resestion, local residual neoplasia
Eligibility Criteria
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
Sites / Locations
- Vitkovice Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Local residual neoplasia
Arm Description
Patients with local residual neoplasia in 3 months after endoscopic resection of colorectal lateral spreading tumors diagnosed endoscopically and/or histologically
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02386618
Brief Title
Endoscopic Treatment for Local Residual Neoplasia
Official Title
Endoscopic Treatment for Local Residual Neoplasia After Endoscopic Mucosal Resection of the Colorectal Lateral Spreading Tumors (LST)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vitkovice Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, laterally spreading tumors, endoscopic mucosal resestion, local residual neoplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local residual neoplasia
Arm Type
Other
Arm Description
Patients with local residual neoplasia in 3 months after endoscopic resection of colorectal lateral spreading tumors diagnosed endoscopically and/or histologically
Intervention Type
Procedure
Intervention Name(s)
Standardized endoscopic treatment of local residual neoplasia
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy of endoscopic treatment od local residual neoplasia (absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Premysl Falt, MD, PhD
Organizational Affiliation
Vitkovice Hospital, Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vitkovice Hospital
City
Ostrava
ZIP/Postal Code
703 84
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Treatment for Local Residual Neoplasia
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