How ALPPS surgery affects liver regrowth after major liver cancer operations
Effect and Mechanism of Combined Hepatectomy and Portal Vein Ligation Staged Hepatectomy (ALPPS) on Liver Regeneration in Patients With Hepatobiliary Malignancy
This project will follow adults with liver cancer who undergo ALPPS surgery to see if the quickly regrown liver tissue works well and how that relates to cancer coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07142213 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–75 with hepatocellular carcinoma or cholangiocarcinoma who have bilobar or complex tumors that leave an insufficient future liver remnant and are judged suitable for ALPPS with Child‑Pugh A or B and MELD ≤15.
Not a fit: Patients with poor liver function outside the inclusion limits, unresectable extrahepatic metastases, or those not undergoing ALPPS are unlikely to benefit from this observational project.
Why it matters
Potential benefit: If successful, this could help doctors determine whether ALPPS regrowth produces healthy, functioning liver tissue and guide better selection of patients for surgery.
How similar studies have performed: Previous studies have shown ALPPS causes faster and larger liver volume increases than conventional two‑stage hepatectomy, but evidence is mixed about the functional quality of that regeneration and long‑term cancer outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Haitao Zhao
- Email: zhaoht@pumch.cn
- Phone: 86-010-69156042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.