Effect and Mechanism of ALPPS Operation on Liver Regeneration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHaitao Zhao, MD
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients with radiologically or pathologically confirmed hepatobiliary malignancies
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ALPPS
Procedure/SurgeryIn 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: ALPPS group1 intervention
Trial outcomes
Primary outcomes
1
Residual liver volume
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).
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Haitao Zhao, MD
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov