Technical Failure During Colorectal Endoscopic Full Thick... | NCT05913453

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

NCT05913453

Sponsor

Azienda Unità Sanitaria Locale della Romagna

Status

Completed

Last Update Posted

Jun 22, 2023Actual

Enrollment

77Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2022Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Jan 31, 2023Actual

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

Jun 12, 2023

First Posted Date

Jun 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2023

Last Update Posted Date

Jun 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlo Fabbri, Dr., Azienda Unità Sanitaria Locale della RomagnaPrincipal Investigator

Lead Sponsor

Azienda Unità Sanitaria Locale della RomagnaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Label	Type	Description	Intervention Names
Procedures corresponding to technical failure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing colorectal EFTR with occurrence of technical failure.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale Morgagni-Pierantoni		Forlì	Forlì-Cesena		Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38754466	Derived	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.