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

Completed

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

• Registration Number: NCT05913453
• Lead Sponsor: Azienda Unità Sanitaria Locale della Romagna

Brief Summary

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.

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 Timeline

• Study Start: 2022-11-30
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical failure rate and classification	2014 - 2022

Secondary Outcome Measures

Name	Time	Method
Complication rate	2014-2022
Clinical success (R0 resection)	2014-2022
Conservative Management of technical failure	2014-2022	Performance of rescue endoscopic resection

Trial Locations

Locations (1)

Ospedale Morgagni-Pierantoni; 🇮🇹 Forlì, Forlì-Cesena, Italy