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Status unknownNCT04559451Updated Mar 18, 2021

Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI

An observational study in Liver Function Failure and Liver Malignant Tumors, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-18.

Sponsored by Peking University Third Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Liver Function Failure
  • Liver Malignant Tumors

Keywords

  • Gd-EOB-DTPA Enhanced MRI
  • ALPPS
  • liver failure
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 350 observational studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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).

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • complete right portal vein thrombosis;
  • serum platelet count \< 50×109/L;
  • clinical signs of portal hypertension such as ascites, and/or intra-abdominal varices.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 90 days after the operation

Secondary outcomes

  1. Postoperative morbidities and mortalities

    Postoperative morbidities and mortalities were graded according to the Clavien classification.

    Time frame: Within 90 days after the operation

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04559451
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Sep 22, 2020
Start date
Oct 1, 2020
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 18, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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