NCT04868149Completed
Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS
Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 28 Dec 2020
- Start date
- 2 Sept 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- The University of Hong Kong
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04868149
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 2 Sept 2020 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Decompensated liver disease as indicated by the presence of ascites, varices and hepatic encephalopathy
- Main portal vein thrombosis
Other
- Absence of consent
- ECOG performance status \>/= 3
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.