RecruitingNCT07142213

Effect and Mechanism of ALPPS Operation on Liver Regeneration

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

Sponsor

Haitao Zhao, MD

Enrollment

50 participants

Start Date

Jan 1, 2020

Study Type

OBSERVATIONAL

Conditions

Liver Cancer Hepatobiliary Cancers Liver Regeneration Hepato Cellular Carcinoma (HCC)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how a complex two-stage liver surgery technique called ALPPS affects liver regrowth and the molecular mechanisms involved. ALPPS is used when a patient needs a large liver tumor removed but does not have enough healthy liver remaining — the surgery is done in two steps to allow the liver to grow before the second operation. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with liver or bile duct cancer (hepatocellular carcinoma or cholangiocarcinoma) - Your liver function is adequate (Child-Pugh A or B) - The remaining liver after surgery would be too small for a standard one-stage operation - Your cancer has not spread to unresectable locations outside the liver **You may NOT be eligible if...** - After the first surgery, your remaining liver did not grow enough to safely proceed with the second surgery - You have significant liver scarring (cirrhosis) or severe fatty liver - You have major heart, kidney, or lung disease that makes major surgery too risky - You developed serious complications after the first surgical step - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREALPPS

In recent years, Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) provides new hope for the solution of large/unresectable hepatobiliary malignancies. This technique promotes the rapid proliferation and regeneration of the remaining liver by separating the liver and ligation of the portal vein, so that the patients whose original liver function is not enough to tolerate large-scale liver resection can complete liver regeneration in a short time, so as to perform secondary resection. Compared with traditional two-stage hepatectomy, ALPPS significantly speeds up the rate of liver regeneration, shortens the waiting time for a second surgery, and provides a safer radical treatment for tumors in high-risk patients.