Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia
1 other identifier
interventional
80
1 country
1
Brief Summary
Most of the cancers develop from the adenomatous polyps. The therapeutic methods have been established already - endoscopic polypectomy (EPE) for stalked polyps and endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for non-pedunculated polyps. EMR is preferred in European countries over ESD because of its higher feasibility. However, the local residual neoplasia (LRN) after EMR has been reported in 14 - 24 % cases. There is a higher LRN risk in sessile polyps which do not elevate sufficiently after the submucosal injection (non-lifting sign) and the piece-meal resection needs to be used. Therefore, the new method of endoscopic full-thickness resection (FTR) has been developed to resect these lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
May 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 20, 2022
April 1, 2022
3 years
March 7, 2019
April 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of R0 procedures
proportion of patients with resection specimens with negative horizontal and vertical margins confirmed by histopathology
3 months
Secondary Outcomes (1)
Proportion of curative resections
12 months
Study Arms (2)
EMR/ESD
EXPERIMENTALStandard EMR or ESD technique
Over- the- scope full- thickness resection device
EXPERIMENTALEndoscopic full thickness resection
Interventions
Endoscopic mucosal resection using a resection snare Endoscopic submucosal dissection using an electrosurgical knife
Endoscopic resection of neoplastic lesions of the colon using the over- the- scope full- thickness resection device
Eligibility Criteria
You may qualify if:
- age ≥ 18 years
- colorectal lesions of 10-25 mm size with positive non-lifting sign
- signed informed consent with the study and with colonoscopy
You may not qualify if:
- age \< 18 years
- lesions \> 25 mm
- pedunculated polyps
- colorectal stenosis
- colonoscopy contraindication
- severe acute inflammatory bowel disease
- severe comorbidities
- patient not able to sign the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Military University Hospital, Praguelead
- Masaryk Universitycollaborator
- University Hospital Olomouccollaborator
Study Sites (1)
Military University Hospital
Prague, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stepan Suchanek, MD., Ph.D
Military University Hospital, Prague
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Endoscopy unit
Study Record Dates
First Submitted
March 7, 2019
First Posted
March 11, 2019
Study Start
May 31, 2019
Primary Completion
June 1, 2022
Study Completion
December 1, 2022
Last Updated
April 20, 2022
Record last verified: 2022-04