Hepatic LesionsDuodenalNCT06190821
Hydrodissection of the Hepatoduodenal Ligament
An observational study of Hepatic Lesions, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Lesions
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2022to 20 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- Opposition to the reuse of his/her data for the purpose of scientific research.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Imagerie interventionnelle oncologique et viscérale - CHU de Strasbourg - France
Strasbourg, 67091
Julien GARNON, MD, PhD, 33 3.69.55.03.04, julien.garnon@chru-strasbourg.fr
Julien GARNON, MD, PhD
About this study
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.
- Conditions
- Hepatic Lesions
- Keywords
- hepatic lesions, liver lesions, duodenum, hepato duodenal ligament
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the hepatoduodenal ligament dissection in the percutaneous treatment of liver lesions adjacent to the duodenum
This study is retrospective
Measured: Files analysed retrospectively from January 01, 2019 to July 31, 2022 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Jul 2022
- Primary completionFeb 2025 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic LesionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190821
- Sponsor's protocol ID
- 8695
- Acronym
- Duodenal
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrodissection of the Hepatoduodenal Ligament
- ClinicalTrials.gov ID
- NCT06190821
- Acronym / sponsor ID
- Duodenal / 8695
- Conditions
- Hepatic Lesions
- Keywords
- hepatic lesions, liver lesions, duodenum, hepato duodenal ligament
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Opposition to the reuse of his/her data for the purpose of scientific research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective description of the hepatoduodenal ligament dissection in the percutaneous treatment of liver lesions adjacent to the duodenum
Time frame: Files analysed retrospectively from January 01, 2019 to July 31, 2022 will be examined
This study is retrospective
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Lesions, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien GARNON, MD (33 3.69.55.03.04, julien.garnon@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the hepatoduodenal ligament dissection in the percutaneous treatment of liver lesions adjacent to the duodenum (time frame: Files analysed retrospectively from January 01, 2019 to July 31, 2022 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.