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

Colorectal Neoplasms Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05502276
• Other study ID #: RESECT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Procedure:
• Endoscopic Full-Thickness Resection (EFTR)
Full Thickness Endoscopic Resection using the FTRD Ovesco Device
• Endoscopic Submucosal Dissection (ESD)
Standard Endoscopic Submucosal Dissection using standard procedure described in international guidelines.

Locations

Country	Name	City	State
Italy	Ospedale Dei Castelli	Ariccia	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

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