Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS: A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Hong Kong Special Administrative Region
The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Albert Chan
acchan@hku.hk
+85222553025
Backup
Crystal Kwan
cryskal@hku.hk
+85222556646
Time Frame
Start Date: 2020-09-02
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Laparoscopic ALPPS
Laparoscopic ALPPS procedure
Active_comparator: Open ALPPS
Open ALPPS procedure
Related Therapeutic Areas
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov