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Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia

NCT03868605 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-04-20

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

EMR and ESD

Endoscopic mucosal resection using a resection snare Endoscopic submucosal dissection using an electrosurgical knife

DEVICE

Over- the- scope full- thickness resection device

Endoscopic resection of neoplastic lesions of the colon using the over- the- scope full- thickness resection device

Sponsors & Collaborators

  • Masaryk University

    collaborator OTHER

  • University Hospital Olomouc

    collaborator OTHER

  • Military University Hospital, Prague

    lead OTHER

Principal Investigators

  • Stepan Suchanek, MD., Ph.D · Military University Hospital, Prague

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868605 on ClinicalTrials.gov