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

NCT04559451 | Unknown

• 1 other identifier: PekingUTH-ALPPS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Function Failure; Liver Malignant Tumors

Keywords

Gd-EOB-DTPA Enhanced MRI; ALPPS; liver failure

Outcome Measures

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.

  Within 90 days after the operation

Secondary Outcomes (1)

• Postoperative morbidities and mortalities

  Within 90 days after the operation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

In order to further elucidate the molecular mechanism for the liver hypertrophy induced by the ALPPS, the blood sample and liver tissue sample before the first \& second stage ALPPS operations will be collected under the permission of the patients.

MeSH Terms

Conditions

Hepatic Insufficiency; Carcinoma, Hepatocellular; Liver Failure

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

CN (1)