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Compares treatment options for Liver Cancer
Official title Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS
ClinicalTrials.gov ID: NCT04868149
What this study is testing
- What it's testing
- 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 major liver resection. It is a two-staged operation with stage I including portal vein ligation and splitting the right liver away from the left liver.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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%
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.