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

Endoscopic Full Thickness Resection (EFTR) Versus Endoscopic Submucosal Dissection (ESD) in the Treatment of Difficult Colorectal Lesions With Dimensional Cut-off ≤ 30mm: Laterally Spreading Tumor Non Granular Type (LST-NG), no Lift Lesions and Residual / Relapses of Previous Resections. Endoscopic.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05502276

Enrollment

Registered

2022-08-16

Start date

2019-01-01

Completion date

2022-09-30

Last updated

2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Brief summary

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

Interventions

PROCEDUREEndoscopic Full-Thickness Resection (EFTR)

Full Thickness Endoscopic Resection using the FTRD Ovesco Device

PROCEDUREEndoscopic Submucosal Dissection (ESD)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
En-bloc resection rate	1 year	the rate of one-piece resection of the lesions
R0 resection rate	1 year	percentage of patients with histologically negative lateral and deep margins

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026