Status:
RECRUITING
Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS
Lead Sponsor:
The University of Hong Kong
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a new surgical procedure that induces rapid liver regeneration in patients with small liver remnant planning for ...
Detailed Description
Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) has been popularized as an alternative approach for FLR augmentation in recent years. The main indication at the ear...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of malignant liver tumor contemplating for extended right hepatectomy or right trisectionectomy
- Patient consent
- Age \>/= 18
- FLR/ESLV \</= 30%
- Indocyanine green clearance rate at 15 mins : \< 18%
- Platelet count \> 100x10\^9/L
- Child A cirrhosis (due to hepatitis B/C virus, or alcohol, or autoimmune disease)
- American Society of Anaesthesiology score \< 3
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Technical factors eligible for laparoscopic ALPPS
- single long-segment portal
Exclusion
- Absence of consent
- Decompensated liver disease as indicated by the presence of ascites, varices and hepatic encephalopathy
- ECOG performance status \>/= 3
- Main portal vein thrombosis
- 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
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04868149
Start Date
September 2 2020
End Date
December 31 2027
Last Update
August 15 2024
Active Locations (1)
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1
The University of Hong Kong
Hong Kong, Hong Kong