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OpenTrials
Completed

NCT Number: NCT05502276

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

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

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Dei Castelli

Ariccia, Rome, 00040, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. En-bloc resection rate

    Time frame: 1 year

    the rate of one-piece resection of the lesions

  2. R0 resection rate

    Time frame: 1 year

    percentage of patients with histologically negative lateral and deep margins

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2022
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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