Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia

NCT ID: NCT03868605

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2022-12-31

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.

Detailed Description

In this project, 80 individuals (age ≥ 18 years) with colorectal lesions of 10-25 mm size with positive non-lifting sign will be included. Such lesions might be found during the colonoscopies at the trial endoscopy centers or at the cooperating referring endoscopy centers outside the study. Patient will be scheduled for the index therapeutic colonoscopy (iTC) and randomized in two groups - FTR group (therapy with FTRD) and ST group (standard therapy, EMR or ESD due to the indication, decided by the endoscopist). First follow-up colonoscopy (FC1) will be performed in 6 months interval. In case of LRN negativity at FC1, the second follow-up colonoscopy (FC2) will be done after 12 months (18 months since iTC). In case of LRN positivity at FC1, the LRN therapeutic colonoscopy (LRN-TC) will follow with the endoscopic method due the findings (patients will be divided into four groups): APC group (LRN ≤ 5 mm; APC therapy), EMR group (LRN > 5 mm and negative non-lifting sign negative; EMR therapy), FTR group (LRN > 5 mm and positive non-lifting sign; therapy with FTRD) and surgery group (complex lesion; surgical therapy). In some LRN positive cases, FC1 will be the same as LRN-TC. The first follow-up colonoscopy after LRN therapy (LRN-FC1) will be performed after 6 months (12 months since TC). In case of re-LRN negativity at LRN-FC1 the second follow-up colonoscopy after LRN therapy (LRN-FC2) will be done after 6 months (18 months since iTC). In case of re-LRN positivity at LRN- FC1 the therapy will be done same as during FC1 and next follow-up will be done outside this trial. In some re-LRN positive cases, LRN-FC1 will be the same as re-LRN-TC. In conclusion, all patients will be followed-up within the study for 18 months, if timely possible.

Conditions

Polyps; Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMR/ESD

Standard EMR or ESD technique

Group Type: EXPERIMENTAL

EMR and ESD

Intervention Type: DEVICE

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

Over- the- scope full- thickness resection device

Endoscopic full thickness resection

Group Type: EXPERIMENTAL

Over- the- scope full- thickness resection device

Intervention Type: DEVICE

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

Interventions

EMR and ESD

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years
• colorectal lesions of 10-25 mm size with positive non-lifting sign
• signed informed consent with the study and with colonoscopy

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masaryk University

OTHER

Sponsor Role: collaborator

University Hospital Olomouc

OTHER

Sponsor Role: collaborator

Military University Hospital, Prague

OTHER

Sponsor Role: lead

Responsible Party

Stepan Suchanek, MD., Ph.D.

Head of Endoscopy unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stepan Suchanek, MD., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Military University Hospital, Prague

Locations

Military University Hospital

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Stepan Suchanek, MD., Ph.D.

Role: CONTACT

stepan.suchanek@uvn.cz

973208367 ext. 00420

Michal Voska, MD.

Role: CONTACT

michal.voska@uvn.cz

773200360 ext. 00420

Facility Contacts

Stepan Suchanek, Ph.D.

Role: primary

Other Identifiers

NV-18-08-00246

Identifier Type: -

Identifier Source: org_study_id