Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Polyps; Colon Cancer
• Intervention / Treatment: Device: EMR and ESD; Device: Over- the- scope full- thickness resection device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michal Voska, MD.; Phone Number: 00420 773200360; Email: michal.voska@uvn.cz

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • Military University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMR/ESD; Standard EMR or ESD technique	Device: EMR and ESD; Endoscopic mucosal resection using a resection snare Endoscopic submucosal dissection using an electrosurgical knife
Experimental: Over- the- scope full- thickness resection device; Endoscopic full thickness resection	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of R0 procedures	proportion of patients with resection specimens with negative horizontal and vertical margins confirmed by histopathology	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of curative resections	Proportion of the LRN at 6 months and 12 months follow-up colonoscopy after the index therapeutic colonoscopy	12 months

Collaborators and Investigators

• Sponsor: Military University Hospital, Prague
• Collaborators: University Hospital Olomouc; Masaryk University
• Investigators: Principal Investigator: Stepan Suchanek, MD., Ph.D, Military University Hospital, Prague

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: NV-18-08-00246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No