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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05913453
Enrollment
77
Registered
2023-06-22
Start date
2022-11-30
Completion date
2023-01-31
Last updated
2023-06-22

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

Conditions

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

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.

Interventions

None listed

Sponsors

Azienda Unità Sanitaria Locale della Romagna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Technical failure rate and classification2014 - 2022

Secondary

MeasureTime frameDescription
Conservative Management of technical failure2014-2022Performance of rescue endoscopic resection
Clinical success (R0 resection)2014-2022
Complication rate2014-2022

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026