NCT04868149 Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS
| NCT ID | NCT04868149 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The University of Hong Kong |
| Condition | Liver Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-09-02 |
| Primary Completion | 2023-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2020-09-02 with a primary completion date of 2023-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patients with a diagnosis of malignant liver tumor contemplating for extended right hepatectomy or right trisectionectomy 2. Patient consent 3. Age \>/= 18 4. FLR/ESLV \</= 30% 5. Indocyanine green clearance rate at 15 mins : \< 18% 6. Platelet count \> 100x10\^9/L 7. Child A cirrhosis (due to hepatitis B/C virus, or alcohol, or autoimmune disease) 8. American Society of Anaesthesiology score \< 3 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Technical factors eligible for laparoscopic ALPPS * single long-segment portal Exclusion Criteria: 1. Absence of consent 2. Decompensated liver disease as indicated by the presence of ascites, varices and hepatic encephalopathy 3. ECOG performance status \>/= 3 4. Main portal vein thrombosis 5. 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
Contact & Investigator
Albert Chan
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT04868149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04868149 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT04868149 currently recruiting?
Yes, NCT04868149 is actively recruiting participants. Contact the research team at acchan@hku.hk for enrollment information.
Where is the NCT04868149 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT04868149 clinical trial?
NCT04868149 is sponsored by The University of Hong Kong. The principal investigator is Albert Chan at The University of Hong Kong. The trial plans to enroll 40 participants.
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