Malignant Liver TumorNCT03995459
Deportalization, Venous Deprivation, Venous Congestion
An observational study of Malignant Liver Tumor, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Patients with multiple primary or secondary liver tumors have a low survival rate unless they can benefit from curative extended hepatic resections with R0 or R1 marge resection. Post-operative acute liver failure may occur after such surgery when the remnant liver is insufficient, leading to high morbimortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Liver Tumor
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 1 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the investigator's institution for major hepatectomy in a context of small FLR. Small FRL was defined as baseline FLR function (clearance rate of 99mTc-mebrofenin) <2.69%/min/m2
Who may be able to join
- Age > or = 18 years
- primary or secondary liver tumor(s)
- major hepatectomy approved by multidisciplinary tumor meeting
- small FRL (baseline FLR <2.69%/min/m2)
Who cannot join
- liver fibrosis / cirrhosis
- biliary obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deportalization, Venous Deprivation, Venous Congestion: Impact on Liver Volume and Function
Patients with multiple primary or secondary liver tumors have a low survival rate unless they can benefit from curative extended hepatic resections with R0 or R1 marge resection. Post-operative acute liver failure may occur after such surgery when the remnant liver is insufficient, leading to high morbimortality.
The future remnant liver (FRL) preoperative evaluation is then the key consideration before performing extended liver resection. The FRL volume measurement on computed tomography (CT) imaging is the most widespread method of FRL evaluation. Threshold values of acceptable FRL volume depend on the underlying liver function, it ranges from 20-30% in healthy liver to 40% in cirrhotic liver. However, it recently appeared that the FRL function would be more valuable in predicting post-operative liver failure. 99mTc-mebrofenin hepatobiliary scintigraphy (HBS) combined with SPECT/CT enables reliable FRL function measurement with a threshold value calculated at 2.69%/min/m2, to predict post-hepatectomy liver failure.
Read more
When the FRL evaluation does not reach the acceptable threshold values to avoid liver failure, portal vein embolization (PVE), consisting of portal branches occlusion of the future removed liver, can be performed. It is now the standard of care to induce FRL regeneration before surgery. Right PVE induces right hemiliver (S5-8) deportalization (portal input deprivation with hepatic venous drainage preservation) leading to left hemiliver (S2-4) regeneration.
To optimize PVE results, recent effective techniques have been developed such as the simultaneous embolization of the right portal branch and the right hepatic vein (HV), and the right accessory HV if so, which is called liver venous deprivation technique. Additional simultaneous embolization of the middle HV defined the extended liver venous deprivation (ELVD) technique. ELVD induces right liver (S5-8) venous deprivation (deprivation of both portal input and venous drainage) and leads to rapid increase in FRL function. After ELVD, segment IV (S4) portal input from left portal branch is preserved while its venous drainage through the middle HV is disrupted, resulting in venous congestion.
The aim of this study is to analyze the volumetric and functional evolutions after embolization procedures in deportalized liver (S5-8 after PVE), vein-deprived liver (S5-8 after ELVD) and congestive liver (S4 after ELVD).
- Conditions
- Malignant Liver Tumor
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline liver volume
- Change from baseline liver volume (expressed in mL, assessed by manual regional volumetric measurements on CT) in the deportalized liver, the vein deprived liver and the congestive liver at day 7, day 14 and day 21.
Measured: day 7, day 14 and day 21
Evolution from baseline of liver volume and liver function values
Evolution from baseline of liver volume and liver function values in the deportalized liver, the vein deprived liver and the congestive liver respectively : liver function (%/min/m2): assessed by regional measurements on 99mTC-mebrofenin hepatobiliary scintigraphy
Measured: 1 day
Secondary outcomes (2)
Evolution from baseline of liver volume and liver function values
Evolution from baseline of liver volume and liver function values in the non embolized liver : liver volume (mL): assessed by manual regional volumetric measurements on CT at baseline, day 7, day 14 and day 21
Measured: day 7, day 14 and day 21
Evolution from baseline of liver volume and liver function values
Evolution from baseline of liver volume and liver function values in the non embolized liver : liver function (%/min/m2): assessed by regional measurements on 99mTC-mebrofenin hepatobiliary scintigraphy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Apr 2019
- Primary completion30 Apr 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Liver TumorStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORIS GUIU, PU-PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995459
- Sponsor's protocol ID
- RECHMPL19_0250
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deportalization, Venous Deprivation, Venous Congestion: Impact on Liver Volume and Function
- ClinicalTrials.gov ID
- NCT03995459
- Acronym / sponsor ID
- RECHMPL19_0250
- Conditions
- Malignant Liver Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 24 Jun 2019 (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.
Patients with multiple primary or secondary liver tumors have a low survival rate unless they can benefit from curative extended hepatic resections with R0 or R1 marge resection. Post-operative acute liver failure may occur after such surgery when the remnant liver is insufficient, leading to high morbimortality.
The future remnant liver (FRL) preoperative evaluation is then the key consideration before performing extended liver resection. The FRL volume measurement on computed tomography (CT) imaging is the most widespread method of FRL evaluation. Threshold values of acceptable FRL volume depend on the underlying liver function, it ranges from 20-30% in healthy liver to 40% in cirrhotic liver. However, it recently appeared that the FRL function would be more valuable in predicting post-operative liver failure. 99mTc-mebrofenin hepatobiliary scintigraphy (HBS) combined with SPECT/CT enables reliable FRL function measurement with a threshold value calculated at 2.69%/min/m2, to predict post-hepatectomy liver failure.
When the FRL evaluation does not reach the acceptable threshold values to avoid liver failure, portal vein embolization (PVE), consisting of portal branches occlusion of the future removed liver, can be performed. It is now the standard of care to induce FRL regeneration before surgery. Right PVE induces right hemiliver (S5-8) deportalization (portal input deprivation with hepatic venous drainage preservation) leading to left hemiliver (S2-4) regeneration.
To optimize PVE results, recent effective techniques have been developed such as the simultaneous embolization of the right portal branch and the right hepatic vein (HV), and the right accessory HV if so, which is called liver venous deprivation technique. Additional simultaneous embolization of the middle HV defined the extended liver venous deprivation (ELVD) technique. ELVD induces right liver (S5-8) venous deprivation (deprivation of both portal input and venous drainage) and leads to rapid increase in FRL function. After ELVD, segment IV (S4) portal input from left portal branch is preserved while its venous drainage through the middle HV is disrupted, resulting in venous congestion.
The aim of this study is to analyze the volumetric and functional evolutions after embolization procedures in deportalized liver (S5-8 after PVE), vein-deprived liver (S5-8 after ELVD) and congestive liver (S4 after ELVD).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the investigator's institution for major hepatectomy in a context of small FLR. Small FRL was defined as baseline FLR function (clearance rate of 99mTc-mebrofenin) <2.69%/min/m2
Key inclusion criteria (4 listed)
- Age > or = 18 years
- primary or secondary liver tumor(s)
- major hepatectomy approved by multidisciplinary tumor meeting
- small FRL (baseline FLR <2.69%/min/m2)
Key exclusion criteria (2 listed)
- liver fibrosis / cirrhosis
- biliary obstruction
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
Change from baseline liver volume
Time frame: day 7, day 14 and day 21
1. Change from baseline liver volume (expressed in mL, assessed by manual regional volumetric measurements on CT) in the deportalized liver, the vein deprived liver and the congestive liver at day 7, day 14 and day 21.
Evolution from baseline of liver volume and liver function values
Time frame: 1 day
Evolution from baseline of liver volume and liver function values in the deportalized liver, the vein deprived liver and the congestive liver respectively : liver function (%/min/m2): assessed by regional measurements on 99mTC-mebrofenin hepatobiliary scintigraphy
2 secondary outcomes
Evolution from baseline of liver volume and liver function values
Time frame: day 7, day 14 and day 21
Evolution from baseline of liver volume and liver function values
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Malignant Liver Tumor
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
RecruitingPhase 2
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Metastatic Colorectal Cancer (Mcrc), Intrahepatic Cholangiocarcinoma (Icc)
Recruiting
Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases
Colorectal Cancer, Colorectal Neoplasms Malignant
Active, not recruitingPhase 2
Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study
Malignant Liver Neoplasm
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.
BORIS GUIU, PU-PH study director
University Hospital, Montpellier
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 Malignant Liver Tumor, run by University Hospital, Montpellier 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 12 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline liver volume (time frame: day 7, day 14 and day 21). The study lists 2 primary outcomes in all. 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 12 Aug 2019.