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

Recruiting now · Phase 3

Conditions studied: Liver Cancer

In brief

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. After stage I, the left liver will undergo rapid liver regeneration and the stage II operation can be performed at 7-10 days after stage I operation when the liver remnant reaches an adequate size. In stage II operation, the right liver that contains the tumor is then removed. This surgical procedure was incepted in Germany in 2013 and was later started in Queen Mary Hospital in Hong Kong for the first time in December 2015. The initial indication was mainly for colorectal liver metastasis but due to the relatively high incidence of hepatocellular carcinoma in Hong Kong, HBP surgery team of Queen Mary Hospital has transferred this procedure to be applied for hepatitis-related hepatocellular carcinoma and so far, the centre has cumulated one of the largest single-center experience in the literature. Nonetheless, the usual approach for ALPPS involved open surgery and induced substantial surgical stress to the patient, especially after stage I operation. With the advent of minimally invasive liver surgery in recent years, the team has successfully applied laparoscopic surgery to ALPPS in 2019. Despite the advancement in laparoscopic surgical skills that rendered laparoscopic ALPPS feasible, there is scarcity of data in the literature to evaluate its outcome in comparison with open ALPPS with regard to perioperative recovery and liver regeneration. Hence, the aim of this project is to evaluate the short-term clinical outcomes of laparoscopic ALPPS and the impact of laparoscopy on liver remnant regeneration after ALPPS in a prospective randomised clinical trial setting.

Key facts

Study ID

NCT04868149

Run by

The University of Hong Kong

People needed

40

Starts

2020-09-02

Expected to finish

2027-12-31

Last updated by the study team

2024-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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%
• 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

You may not qualify 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
• Large tumor size with diameter > 5 cm
• Intolerance to CO2 pneumoperitoneum

Where it is running

• The University of Hong Kong — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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