Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study

Among advanced resection techniques, endoscopic full thickness resection (EFTR) allows closure and full-thickness resection by the use of the non-exposed full thickness resection device (FTRD). The study is a retrospective analysis of technical failure occurring during colorectal full-thickness resection. Full thickness resection is a safe and effective procedure for "difficult" colorectal lesions. However, technical failure can occur and to date there is no evidence about type and clinical consequences in this setting.

Study Overview

• Status: Completed
• Conditions: Colorectal Adenoma; Endoscopic Full Thickness Resection (EFTR); Residual /Recurrent Colorectal Lesion; Full-thickness Resection Device (FTRD); Non-lifting Colorectal Lesions; Intraprocedural Complication

Detailed Description

The study is a multicentre retrospective study involving centres with experience in advanced colorectal resections.

Each centre is invited to submit information about the Centre and to report alle the consecutive cases corresponding to technical failure.

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• Italy
  • Forlì-Cesena
    • Forlì, Forlì-Cesena, Italy
      • Ospedale Morgagni-Pierantoni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing colorectal EFTR with occurrence of technical failure.

Description

Inclusion Criteria:

• Consecutive colorectal EFTR procedures with technical failure by using OVESCO Full Thickness Resection Device

Exclusion Criteria:

• EFTR performed by exposed techniques and/or devices different from FTRD
• Patients not able to give informed consent for data collection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Procedures corresponding to technical failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Technical failure rate and classification	2014 - 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conservative Management of technical failure	Performance of rescue endoscopic resection	2014-2022
Clinical success (R0 resection)		2014-2022
Complication rate		2014-2022

Collaborators and Investigators

• Sponsor: Azienda Unità Sanitaria Locale della Romagna

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 2993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual Participant Data require data about experience in colorectal resections and EFTR; each centre will provide details for each technical failure including demographics, lesions characteristics, intraprocedural details and post-procedure outcomes.

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