Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS

Launched by THE UNIVERSITY OF HONG KONG · Apr 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical procedure called ALPPS, which helps patients with liver cancer by encouraging the liver to grow back after part of it is removed. The procedure involves two steps: first, a surgeon will prepare the liver to promote growth, and then, about a week later, they will remove the tumor along with the affected part of the liver. Researchers want to compare two methods of performing ALPPS: the traditional open surgery approach and a newer, less invasive laparoscopic (or keyhole) surgery. They hope to find out which method helps patients recover better and allows the liver to regenerate more effectively.

To be eligible for this trial, participants must be at least 18 years old, have a malignant liver tumor, and be able to give their consent. They should also have specific liver health measurements that suggest they can safely undergo surgery. This trial is currently recruiting participants, and anyone interested should speak with their healthcare provider to see if they qualify. Participants can expect close monitoring during the process and will contribute to important research that may improve liver cancer surgery outcomes in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with a diagnosis of malignant liver tumor contemplating for extended right hepatectomy or right trisectionectomy
• • 2. Patient consent
• • 3. Age \>/= 18
• • 4. FLR/ESLV \</= 30%
• • 5. Indocyanine green clearance rate at 15 mins : \< 18%
• • 6. Platelet count \> 100x10\^9/L
• • 7. Child A cirrhosis (due to hepatitis B/C virus, or alcohol, or autoimmune disease)
• • 8. American Society of Anaesthesiology score \< 3
• • 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• • Technical factors eligible for laparoscopic ALPPS
• • single long-segment portal
• Exclusion Criteria:
• • 1. Absence of consent
• • 2. Decompensated liver disease as indicated by the presence of ascites, varices and hepatic encephalopathy
• • 3. ECOG performance status \>/= 3
• • 4. Main portal vein thrombosis
• • 5. FLR/ESLV \> 30%
• • Technical factors not eligible for laparoscopic ALPPS
• • Short-segment right portal vein or early bifurcation of right anterior/posterior portal vein, or other portal vein anomalies
• • Large tumor size with diameter \> 5 cm
• • Intolerance to CO2 pneumoperitoneum