Status:
RECRUITING
Effect and Mechanism of ALPPS Operation on Liver Regeneration
Lead Sponsor:
Haitao Zhao, MD
Conditions:
Hepato Cellular Carcinoma (HCC)
Hepatobiliary Cancers
Eligibility:
All Genders
18-75 years
Brief Summary
Hepatobiliary malignancies-principally hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA)-are highly aggressive and often diagnosed at advanced stages. Curative-intent liver resection remains...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07142213
Start Date
January 1 2020
End Date
December 31 2028
Last Update
August 26 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730