Actively Recruiting
Effect and Mechanism of ALPPS Operation on Liver Regeneration
Led by Haitao Zhao, MD · Updated on 2025-08-26
50
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatobiliary malignancies-principally hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA)-are highly aggressive and often diagnosed at advanced stages. Curative-intent liver resection remains the standard for resectable disease; however, postoperative outcomes depend on an adequate functional future liver remnant (FLR). Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) induces rapid FLR hypertrophy and has expanded resection eligibility compared with conventional two-stage hepatectomy by shortening the interval to definitive resection. Key uncertainties persist regarding the quality of ALPPS-induced regeneration and its relationship to long-term oncologic outcomes, including recurrence and metastasis. This observational study enrolls patients deemed suitable for ALPPS at Peking Union Medical College Hospital. Perioperative care follows institutional standards; no therapeutic procedures are altered for research purposes. The investigators will collect clinically available liver tissue and relevant medical data obtained during standard surgical care to characterize cellular and molecular programs of regeneration across the ALPPS stages. High-throughput profiling-including single-cell and spatial transcriptomics-will be used to define cell-type composition, transcriptional states, and signaling pathways associated with regeneration. The primary objective is to describe cellular and gene-expression changes in regenerating liver induced by ALPPS. Secondary objectives include exploring associations between regenerative quality and short- and long-term clinical outcomes. Findings are expected to inform potential therapeutic targets and strategies to enhance safe regeneration and improve postoperative prognosis.
CONDITIONS
Official Title
Effect and Mechanism of ALPPS Operation on Liver Regeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Confirmed diagnosis of hepatobiliary malignancy (hepatocellular carcinoma or cholangiocarcinoma) suitable for ALPPS surgery
- Preoperative liver function with Child-Pugh score A or B and MELD score 15 or less
- Liver tumors are bilobal or complex with large areas requiring ALPPS to ensure adequate residual liver volume
- Imaging shows insufficient future liver remnant (FLR) to support standard hepatectomy
- Postoperative assessment shows FLR enlargement as expected (at least 30% increase or FLR/body weight above 0.5) for a second procedure
- No unresectable distant metastases except for resectable lung metastases
You will not qualify if you...
- Residual liver volume did not increase sufficiently after first step (less than 30% increase or FLR/body weight below 0.5)
- Unresectable distant metastases such as extensive bone or lung metastases
- Severe liver disease including Child-Pugh grade C or severe liver sclerosis (Metavir 6F3) or 30% or more hepatic steatosis
- Major illnesses like severe cardiovascular disease, kidney failure, or respiratory failure that prevent major surgery
- Serious complications after first surgery (e.g., liver failure or infection) making second surgery unsuitable
- Abnormal blood supply or function of FLR after first procedure affecting liver regeneration
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
H
Haitao Zhao
CONTACT
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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