Liver Function FailureNCT04559451
Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI
An observational study of Liver Function Failure and Liver Malignant Tumors, run by Peking University Third Hospital at 1 site in China.
Trial summary
Insufficient future liver remnant (FLR), which may render post-hepatectomy liver failure, is one of the major obstacles for performing liver resection for patients with liver malignants. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Function Failure, Liver Malignant Tumors
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Dec 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who underwent ALPPS in Department of General Surgery, Peking University Third Hospital were collected. The indication for the performance of ALPPS were evaluated by multi-disciplinary team (MDT).
Who may be able to join
- future liver remnant volume <30%;
- indocyanine green clearance (ICG) rate <20% at 15 minutes;
- Child A liver function, serum platelet count > 50×109/L;
- good general condition.
Who cannot join
- complete right portal vein thrombosis;
- serum platelet count < 50×109/L;
- clinical signs of portal hypertension such as ascites, and/or intra-abdominal varices.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Mu-xing Li, M.D., +861082267338, limuxing@bjmu.edu.cn
About this study
Insufficient future liver remnant (FLR), which may render post-hepatectomy liver failure, is one of the major obstacles for performing liver resection for patients with liver malignants. Associating liver partition and portal vein ligation (ALPPS) was introduced to induce rapid and extensive liver hypertrophy, which offers the opportunity for removing the liver malignancy in the second stage operation for patients with insufficient FLR at their first stage operation. Feasibility of the second stage of ALPPS has been assessed mostly on the basis of laboratory parameters and volumetry by the 3D reconstruction of CT. Meanwhile, part of the patients who underwent the second stage ALPPS still experienced postoperative liver failure, even in patients with sufficient FLR volume. In other words, this volumetric increase may not reflect the increase of liver function. And the laboratory parameters can only partly reflect the global liver function but not the regional liver function. Therefore, the combination of volumetric and global liver function tests might be unsuitable for predicting FLR function after first stage ALPPS because function is distributed unequally between left and right liver lobe. The Gd-EOB-DTPA-enhanced liver MRI, which has remarkable potential to evaluate regional liver function and could therefore be an ideal diagnostic test for performing volumetric and functional measurement after the first stage ALPPS in one examination. Thus we performed this clinical trial in order to evaluate the efficacy of Gd-EOB-DTPA-enhanced liver MRI in evaluating the FLR liver function after the first stage ALPPS.
Read the detailed description
The clinical data and follow up information of the patients who underwent laparoscopic ALPPS in Department of General Surgery, Peking University Third Hospital were collected. The indication for the performance of the first and second ALPPS was evaluated by multi-disciplinary team (MDT). The liver function evaluation indexes of Gd-EOB-DTPA Enhanced liver MRI such as RE (Relative enhancement of the liver)=（SI20min-SIunenhanced）/ SIunenhanced and other related indexes were calculated. SI referred to signal intensity. SI20 min referred to the signal intensity in the hepatocyte phase (20 min after the injection). The relationship between the indexes and postoperative liver failure as well as other complications were analyzed.
- Conditions
- Liver Function Failure, Liver Malignant Tumors
- Keywords
- Gd-EOB-DTPA Enhanced MRI, ALPPS, liver failure
- Medical subject headings
- Hepatic Insufficiency, Carcinoma, Hepatocellular, Liver Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative liver function failure
The "50-50 criteria" was applied to assess post-treatment liver failure, which considers the increased total bilirubin level (>50 umol/L) and decreased PTA (<50%) on postoperative day 5.
Measured: Within 90 days after the operation
Secondary outcomes (1)
Postoperative morbidities and mortalities
Postoperative morbidities and mortalities were graded according to the Clavien classification.
Measured: Within 90 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Function FailureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559451
- Sponsor's protocol ID
- PekingUTH-ALPPS
- Status last verified
- Mar 2021
- First submitted
- 16 Sep 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI
- ClinicalTrials.gov ID
- NCT04559451
- Acronym / sponsor ID
- PekingUTH-ALPPS
- Conditions
- Liver Function Failure, Liver Malignant Tumors
- Keywords
- Gd-EOB-DTPA Enhanced MRI, ALPPS, liver failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Sep 2020 (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.
Insufficient future liver remnant (FLR), which may render post-hepatectomy liver failure, is one of the major obstacles for performing liver resection for patients with liver malignants. Associating liver partition and portal vein ligation (ALPPS) was introduced to induce rapid and extensive liver hypertrophy, which offers the opportunity for removing the liver malignancy in the second stage operation for patients with insufficient FLR at their first stage operation. Feasibility of the second stage of ALPPS has been assessed mostly on the basis of laboratory parameters and volumetry by the 3D reconstruction of CT. Meanwhile, part of the patients who underwent the second stage ALPPS still experienced postoperative liver failure, even in patients with sufficient FLR volume. In other words, this volumetric increase may not reflect the increase of liver function. And the laboratory parameters can only partly reflect the global liver function but not the regional liver function. Therefore, the combination of volumetric and global liver function tests might be unsuitable for predicting FLR function after first stage ALPPS because function is distributed unequally between left and right liver lobe. The Gd-EOB-DTPA-enhanced liver MRI, which has remarkable potential to evaluate regional liver function and could therefore be an ideal diagnostic test for performing volumetric and functional measurement after the first stage ALPPS in one examination. Thus we performed this clinical trial in order to evaluate the efficacy of Gd-EOB-DTPA-enhanced liver MRI in evaluating the FLR liver function after the first stage ALPPS.
Detailed description
The clinical data and follow up information of the patients who underwent laparoscopic ALPPS in Department of General Surgery, Peking University Third Hospital were collected. The indication for the performance of the first and second ALPPS was evaluated by multi-disciplinary team (MDT). The liver function evaluation indexes of Gd-EOB-DTPA Enhanced liver MRI such as RE (Relative enhancement of the liver)=（SI20min-SIunenhanced）/ SIunenhanced and other related indexes were calculated. SI referred to signal intensity. SI20 min referred to the signal intensity in the hepatocyte phase (20 min after the injection). The relationship between the indexes and postoperative liver failure as well as other complications were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who underwent ALPPS in Department of General Surgery, Peking University Third Hospital were collected. The indication for the performance of ALPPS were evaluated by multi-disciplinary team (MDT).
Key inclusion criteria (4 listed)
- future liver remnant volume <30%;
- indocyanine green clearance (ICG) rate <20% at 15 minutes;
- Child A liver function, serum platelet count > 50×109/L;
- good general condition.
Key exclusion criteria (3 listed)
- complete right portal vein thrombosis;
- serum platelet count < 50×109/L;
- clinical signs of portal hypertension such as ascites, and/or intra-abdominal varices.
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
Postoperative liver function failure
Time frame: Within 90 days after the operation
The "50-50 criteria" was applied to assess post-treatment liver failure, which considers the increased total bilirubin level (>50 umol/L) and decreased PTA (<50%) on postoperative day 5.
1 secondary outcome
Postoperative morbidities and mortalities
Time frame: Within 90 days after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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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 Liver Function Failure and Liver Malignant Tumors, run by Peking University Third Hospital at 1 site in China.
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 3 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 18 Mar 2021. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative liver function failure (time frame: Within 90 days after the operation). 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 18 Mar 2021.