Comparing laparoscopic and open surgery for liver cancer treatment
Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS: A Randomized Clinical Trial
This study is testing whether a new type of surgery done with small cuts can help people with liver cancer recover better and have fewer problems compared to traditional open surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04868149 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a surgical procedure called ALPPS, which involves partitioning the liver and ligating the portal vein to enhance liver regeneration before major liver resection. The study compares outcomes between laparoscopic and open surgical approaches in patients with small future liver remnants due to liver cancer. Participants will undergo a two-stage operation, with the first stage inducing rapid liver growth, followed by the removal of the tumor-containing liver segment. The trial aims to assess the safety and efficacy of laparoscopic ALPPS in improving recovery and reducing complications.
Who should consider this trial
Good fit: Ideal candidates include adults with malignant liver tumors who are considering major liver resection and have a small future liver remnant.
Not a fit: Patients with decompensated liver disease or those with a performance status indicating severe health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and faster recovery for patients with liver cancer.
How similar studies have performed: Previous studies have shown promising results with ALPPS, indicating its potential as a safe and effective treatment for liver cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Albert Chan — The University of Hong Kong
- Study coordinator: Albert Chan
- Email: acchan@hku.hk
- Phone: +85222553025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.