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

NCT ID: NCT05913453

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Procedures corresponding to technical failure

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Unità Sanitaria Locale della Romagna

OTHER

Sponsor Role lead

Responsible Party

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Carlo Fabbri

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale Morgagni-Pierantoni

Forlì, Forlì-Cesena, Italy

Site Status

Countries

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Italy

References

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Gibiino G, Binda C, Papparella LG, Spada C, Andrisani G, Di Matteo FM, Gagliardi M, Maurano A, Sferrazza S, Azzolini F, Grande G, de Nucci G, Cesaro P, Aragona G, Cennamo V, Fusaroli P, Staiano T, Soriani P, Campanale M, Di Mitri R, Pugliese F, Anderloni A, Cucchetti A, Repici A, Fabbri C; "through thick and thin" study group. Technical failure during colorectal endoscopic full-thickness resection: the "through thick and thin" study. Endoscopy. 2024 Nov;56(11):831-839. doi: 10.1055/a-2328-4753. Epub 2024 May 16.

Reference Type DERIVED
PMID: 38754466 (View on PubMed)

Other Identifiers

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2993

Identifier Type: -

Identifier Source: org_study_id

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