Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.

University of Roma La Sapienza90 enrolled

Overview

Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from previous resections endoscopic colon. The dimensional cut off of these lesions is ≤30mm

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Full-Thickness Resection (EFTR)PROCEDURE

Full Thickness Endoscopic Resection using the FTRD Ovesco Device

Endoscopic Submucosal Dissection (ESD)PROCEDURE

Standard Endoscopic Submucosal Dissection using standard procedure described in international guidelines.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * patients of age \>18 years * Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter * "no-lift" colic injuries ≤ 3cm in diameter * residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter Exclusion criteria: * pregnant women * failure to accept or understand the consent to participate in the study * patients with severe coagulopathies * patients with short life expectancy (Charlson comorbidity index ≥8) * patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)

Locations (1)

Ospedale Dei Castelli

Ariccia, Rome, Italy

Outcomes

Primary Outcomes

En-bloc resection rate

the rate of one-piece resection of the lesions

Time frame: 1 year

R0 resection rate

percentage of patients with histologically negative lateral and deep margins

Time frame: 1 year

Data from ClinicalTrials.gov

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