Hydrodissection of the Hepatoduodenal Ligament | NCT06190821

Studies
Hydrodissection of the Hepatoduodenal Ligament

NCT06190821

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jan 5, 2024Actual

Enrollment

13Estimated

Phase

Not provided

Conditions

Hepatic Lesions

Interventions

Not provided

Countries

France

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2022Actual

Primary Completion Date

Feb 2025Estimated

Completion Date

Feb 20, 2025Estimated

First Submitted Date

Sep 6, 2022

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Jan 5, 2024Actual

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

Dec 19, 2023

Last Update Posted Date

Jan 5, 2024Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Percutaneous treatment of liver lesions adjacent to the duodenum exposes the duodenum to the risk of thermal injury, limiting removal and oncologic outcome. In this study the investigators investigate the feasibility of hepato duodenal ligament dissection in the percutaneous treatment of liver lesions adjacent to the duodenum.

Detailed Description

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

13Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective description of the hepatoduodenal ligament dissection in the percutaneous treatment of liver lesions adjacent to the duodenum	This study is retrospective	Files analysed retrospectively from January 01, 2019 to July 31, 2022 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Major subject (≥18 years of age)
Subject who underwent percutaneous ablation of primary or secondary liver lesions at HUS that required per-procedure hepatoduodenal ligament hydrodissection in the interventional imaging department of the New Civil Hospital from January 2019 to July 2022.
Subject who has not expressed opposition to the reuse of their data for the purpose of this research.

Exclusion Criteria:

- Opposition to the reuse of his/her data for the purpose of scientific research.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Major subject (≥18 years of age) who underwent percutaneous ablation of primary or secondary liver lesions at HUS that required per-procedure hepatoduodenal ligament hydrodissection in the interventional imaging department of the New Civil Hospital from January 2019 to July 2022.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julien GARNON, MD	Contact	33 3.69.55.03.04		julien.garnon@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Imagerie interventionnelle oncologique et viscérale - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France