Actively Recruiting

Age: 18Years - 75Years
All Genders
ID07142213

Effect and Mechanism of Combined Hepatectomy and Portal Vein Ligation Staged Hepatectomy (ALPPS) on Liver Regeneration in Patients With Hepatobiliary Malignancy

Led by Haitao Zhao, MD · Updated on 2025-08-26

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effects and mechanisms of the ALPPS procedure on liver regeneration in patients with hepatobiliary cancers, including hepatocellular carcinoma and cholangiocarcinoma. These cancers are aggressive and often diagnosed late. While liver resection offers a chance for cure, success depends on having enough healthy liver left after surgery. ALPPS is a newer surgical method that speeds up liver regrowth, allowing more patients to safely undergo liver removal compared to traditional approaches. The study aims to understand the cellular and genetic changes during liver regeneration caused by ALPPS and how these relate to patient outcomes over time. This observational study involves patients undergoing the ALPPS procedure at a hospital, with no changes made to their standard surgical care. ALPPS involves separating the liver and tying off part of the portal vein to stimulate rapid growth in the remaining liver. Researchers collect liver tissue and medical data during routine care and use advanced techniques like single-cell and spatial transcriptomics to analyze liver cell types and gene activity. The first stage is followed by assessment of liver volume growth before proceeding to the second surgery. Participants will have assessments of their liver volume around 7 and 14 days after the first ALPPS stage, with the main analysis using the last measurement before the second surgery. Researchers will monitor regeneration quality and relate it to short- and long-term clinical outcomes including recurrence. The study collects detailed clinical data and tissue samples without altering treatment, aiming to improve understanding of liver regrowth and inform future therapies. Participation duration depends on surgical timing and follow-up, with safety monitored through standard care.

CONDITIONS

Brief Title

Effect and Mechanism of ALPPS Operation on Liver Regeneration

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 75 years
  • Confirmed diagnosis of hepatobiliary malignancy (including hepatocellular carcinoma and cholangiocarcinoma) suitable for ALPPS surgery
  • Preoperative liver function with Child-Pugh score A or B and MELD score 15 or less
  • Bilobal or complex liver tumors requiring ALPPS to ensure adequate residual liver volume (FLR/TLV <30% or FLR/BW <0.5)
  • Imaging showing insufficient future liver remnant to support standard hepatectomy
  • Postoperative FLR enlargement as expected (at least 30% increase or FLR/BW above 0.5) for second procedure
  • No unresectable extrahepatic metastases except resectable lung metastases
Not Eligible

You will not qualify if you...

  • Residual liver volume did not increase sufficiently after first ALPPS step (<30% increase or FLR/BW <0.5) for second step
  • Unresectable distant metastases such as extensive bone or lung metastases
  • Severe liver disease (Child-Pugh grade C or severe liver sclerosis or ≥30% hepatic steatosis)
  • Major illnesses like severe cardiovascular disease, kidney failure, or respiratory failure preventing major surgery
  • Serious postoperative complications after first step making second step unsuitable
  • Abnormal FLR blood supply or function after first procedure affecting liver regeneration
  • Pregnancy or lactation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Up to 1 month

Participants undergo the first stage of the ALPPS procedure involving liver partition and portal vein ligation, followed by immediate recovery.

Visits around Day 7 (±2 days) and Day 14 (±2 days) after the first ALPPS stage for liver volume assessments

Surgery and Immediate Post-operative Care

Duration - Up to Day 28 after the first stage

Participants undergo the second stage of ALPPS surgery once sufficient liver regeneration is confirmed.

1 visit for the second ALPPS surgery

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

H

Haitao Zhao

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Hepatic artery restriction operation combined with ALPPS (HARO-ALPPS), a novel ALPPS procedure for the treatment of hepatocellular carcinoma with severe fibrosis: retrospective clinical cohort study.

Zhang Wen, Zongrui Jin, Banghao Xu...

https://pubmed.ncbi.nlm.nih.gov/38768472