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NCT Number: NCT07142213

Effect and Mechanism of ALPPS Operation on Liver Regeneration

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.

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Key information

Conditions

Hepato Cellular Carcinoma (HCC) Digestive System Diseases Digestive System Neoplasms Hepatobiliary Cancers Liver Cancer Liver Diseases Liver Neoplasms Liver Regeneration Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Haitao Zhao

CONTACT

[email protected]

86-010-69156042

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age: Patients aged 18 to 75 years
Diagnosis established: A diagnosis of hepatobiliary malignancy (including hepatocellular carcinoma and cholangiocarcinoma) was confirmed and evaluated as suitable for ALPPS surgery
Liver function status: preoperative Child-Pugh score A or B, MELD score ≤15, with sufficient liver function reserve for operation
Tumor characteristics: bilobal or complex tumors of the liver with large tumor areas requiring ALPPS to ensure adequate residual liver volume (FLR/TLV<30% or FLR/BW<0.5)
Preoperative assessment: Imaging showed that future liver residual (FLR) was insufficient to support standard hepatectomy, and liver volume must be increased by ALPPS
FLR enlargement: Postoperative assessment of FLR enlargement as expected (at least 30% enlargement or FLR/BW above 0.5) for a second procedure
No distant metastases: No unresectable extrahepatic metastases, except for resectable lung metastases

Exclusion criteria

Preoperative FLR insufficiency: Residual liver volume (FLR) did not increase sufficiently after the first step (<30% increase or FLR/BW <0.5) to be suitable for the second step
Extrahepatic metastasis: unresectable distant metastasis, such as extensive metastasis of bone, lung, etc
Severe liver disease: very poor liver function before surgery, Child-Pugh grade C or severe liver sclerosis during surgery (e.g. Metavir≥F3 or 30% or more hepatic steatosis)
Major comorbidities: Major illnesses such as severe cardiovascular disease, kidney failure, or respiratory failure that do not tolerate major surgery
Postoperative complications: Serious postoperative complications (such as liver failure, infection, etc.) after the first step are not suitable for the second step
Evaluation of adverse surgery: After the first procedure, FLR blood supply or function is abnormal, affecting liver regeneration
Pregnancy and lactation: pregnant or lactating women

Treatment and study plan

ALPPS

Procedure

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.

Primary outcomes

Residual liver volume

Time frame: Time Frame: Day 7 (±2 days) and Day 14 (±2 days) after Stage-1 ALPPS; primary analysis uses the last assessment obtained prior to Stage-2 (up to Day 28).

Residual liver volume of the future liver remnant (FLR) immediately before Stage-2 resection, quantified by contrast-enhanced CT-based 3D volumetry; reported in milliliters (mL) and as percent of standard liver volume (%SLV).

Study contacts

Contact information is provided by the study sponsor or research team.

Haitao Zhao

CONTACT

[email protected]

86-010-69156042

Sponsors and collaborators

Lead sponsor

Haitao Zhao, MD

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2028
Study completion: 2028
First posted: Aug 26, 2025
Registry last updated: Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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