Actively Recruiting
Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS
Led by The University of Hong Kong · Updated on 2024-08-15
40
Participants Needed
1
Research Sites
382 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a diagnosis of malignant liver tumor planning for extended right hepatectomy or right trisectionectomy
- Patient consent given
- Age 18 years or older
- Future liver remnant (FLR) to estimated standard liver volume (ESLV) ratio less than or equal to 30%
- Indocyanine green clearance rate at 15 minutes less than 18%
- Platelet count greater than 100 x 10^9/L
- Child A cirrhosis due to hepatitis B or C virus, alcohol, or autoimmune disease
- American Society of Anaesthesiology score less than 3
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Technical eligibility for laparoscopic ALPPS includes single long-segment portal vein anatomy
You will not qualify if you...
- Absence of patient consent
- Decompensated liver disease shown by ascites, varices, or hepatic encephalopathy
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- Main portal vein thrombosis
- Future liver remnant (FLR) to estimated standard liver volume (ESLV) ratio greater than 30%
- Technical ineligibility for laparoscopic ALPPS including short-segment right portal vein or early bifurcation of right anterior/posterior portal vein, or other portal vein anomalies
- Large tumor size with diameter greater than 5 cm
- Intolerance to carbon dioxide pneumoperitoneum
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
A
Albert Chan
CONTACT
C
Crystal Kwan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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