Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia

Colon Cancer Clinical Trial

Official title:

Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia - Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03868605
• Other study ID #: NV-18-08-00246
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Military University Hospital, Prague
• Contact: Stepan Suchanek, MD., Ph.D.
• Phone: 973208367
• Email: stepan.suchanek[@]uvn.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Neoplasms
• Polyps

Intervention

Device:
• EMR and ESD
Endoscopic mucosal resection using a resection snare Endoscopic submucosal dissection using an electrosurgical knife
• Over- the- scope full- thickness resection device
Endoscopic resection of neoplastic lesions of the colon using the over- the- scope full- thickness resection device

Locations

Country	Name	City	State
Czechia	Military University Hospital	Prague

Sponsors (3)

Lead Sponsor	Collaborator
Military University Hospital, Prague	Masaryk University, University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of R0 procedures	proportion of patients with resection specimens with negative horizontal and vertical margins confirmed by histopathology	3 months
Secondary	Proportion of curative resections	Proportion of the LRN at 6 months and 12 months follow-up colonoscopy after the index therapeutic colonoscopy	12 months