How ALPPS surgery affects liver regrowth after major liver cancer operations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls adults with hepatobiliary cancers undergoing ALPPS at Peking Union Medical College Hospital and tracks their liver volume, function, and cancer outcomes over time. Perioperative care and surgical decisions are not changed for research purposes; data collection includes imaging of the future liver remnant, laboratory liver function tests, and clinical follow-up for recurrence and complications. The investigators will characterize the quality of ALPPS-induced regeneration at the tissue and functional levels and correlate regeneration metrics with short- and long-term oncologic outcomes. The goal is to clarify which patients benefit most from ALPPS and inform surgical selection and timing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: Patients aged 18 to 75 years
2. Diagnosis established: A diagnosis of hepatobiliary malignancy (including hepatocellular carcinoma and cholangiocarcinoma) was confirmed and evaluated as suitable for ALPPS surgery
3. Liver function status: preoperative Child-Pugh score A or B, MELD score ≤15, with sufficient liver function reserve for operation
4. 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)
5. Preoperative assessment: Imaging showed that future liver residual (FLR) was insufficient to support standard hepatectomy, and liver volume must be increased by ALPPS
6. FLR enlargement: Postoperative assessment of FLR enlargement as expected (at least 30% enlargement or FLR/BW above 0.5) for a second procedure
7. No distant metastases: No unresectable extrahepatic metastases, except for resectable lung metastases

Exclusion Criteria:

1. 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
2. Extrahepatic metastasis: unresectable distant metastasis, such as extensive metastasis of bone, lung, etc
3. 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)
4. Major comorbidities: Major illnesses such as severe cardiovascular disease, kidney failure, or respiratory failure that do not tolerate major surgery
5. Postoperative complications: Serious postoperative complications (such as liver failure, infection, etc.) after the first step are not suitable for the second step
6. Evaluation of adverse surgery: After the first procedure, FLR blood supply or function is abnormal, affecting liver regeneration
7. Pregnancy and lactation: pregnant or lactating women

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Haitao Zhao
• Email: zhaoht@pumch.cn
• Phone: 86-010-69156042

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.