Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Liver Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: Patient are randomly assigned into either open or laparoscopic approach. The ratio of open and laparoscopic is 1:1.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) has been popularized as an alternative approach for FLR augmentation in recent years. The main indication at the early phase of development of this procedure was bilobar colorectal liver metastasis, or other non-prim...
Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) has been popularized as an alternative approach for FLR augmentation in recent years. The main indication at the early phase of development of this procedure was bilobar colorectal liver metastasis, or other non-primary liver tumors. Since 2015, HBP surgery team of Queen Mary Hospital has started to transfer this novel approach to treat patients with hepatitis-related hepatocellular carcinoma and small future liver remnant contemplating for major hepatectomy. Despite the initial global enthusiasm to embark on ALPPS, the procedure was criticized for its high postoperative morbidity and mortality rates. However, through the establishment of the international ALPPS registry and familiarization of the procedure, the outcome of ALPPS has been benchmarked and standardized with a mortality rate <4%. The initial experience of ALPPS for HCC was also reported. With cumulative experience, ALPPS has become a safe and effective treatment approach for surgical modulation of insufficient FLR when compared with the conventional approach in the form of portal vein embolization. Nonetheless, ALPPS is a two-stage procedure that commonly involved an open laparotomy. However, the postoperative pain control and speed of recovery after stage I ALPPS would be affected by the substantial surgical stress induced by laparotomy. On the other hand, the rapid development of laparoscopic surgery has rendered laparoscopic liver surgery a much more feasible and safer surgical approach in recent years. As such, minimally invasive approach becomes an attractive option for ALPPS, at least for stage I procedure. Data on the application of laparoscopic ALPPS remained scarce with only one study reported the short-term outcome in a series of 10 patients predominantly affected by colorectal liver metastasis. Since the short-term postoperative safety profile and underlying intraoperative haemodynamic changes induced by ALPPS for hepatitis-related HCC under conventional open approach was ascertained by our recent study, it is considered that it is the right time to introduce laparoscopy for ALPPS and to compare its clinical outcome with open approach. To date, a total of 4 patients have received laparoscopic ALPPS in the centre. Recent studies suggested that laparoscopic liver resection may be associated with reduced inflammatory and stress response as compared with open resection as indicated by a reduced expression of inflammatory cytokines such as interleukin-6, tumor necrosis factor. On the other hand, study on liver regeneration after open ALPPS showed an elevated gene expression of IL-6 and TNF as well as increased plasma levels within 24 hours after the procedure when compared with portal vein ligation. It remains uncertain if reduced level of cytokines or inflammatory markers induced by laparoscopy would affect the liver regeneration rate in ALPPS patients and its clinical outcome. Hence, there is a need to clarify this issue in the current project.
Tracking Information
- NCT #
- NCT04868149
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Albert Chan The University of Hong Kong