Comparing laparoscopic and open surgery for liver cancer treatment
Asia-Pacific Multi-Centre Randomized Trial of Laparoscopic Versus Open Major Hepatectomy for Hepatocellular Carcinoma (AP-LAPO Trial)
This study is testing whether a less invasive liver surgery can help people with liver cancer recover better and live longer compared to traditional open surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04852211 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the long-term outcomes of laparoscopic major hepatectomy (LMH) versus open major hepatectomy (OMH) in patients diagnosed with hepatocellular carcinoma (HCC). The study focuses on evaluating the potential benefits of LMH, which is a minimally invasive technique that may reduce complications and improve recovery times compared to traditional open surgery. By analyzing factors such as tumor recurrence rates and overall survival, the trial seeks to determine if LMH offers superior oncological outcomes. Participants will undergo either surgical approach based on their eligibility and the judgment of hepatobiliary surgeons.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with hepatocellular carcinoma requiring major hepatectomy, with tumors up to 10 cm in size and no evidence of extrahepatic metastasis.
Not a fit: Patients with advanced liver disease, extrahepatic metastasis, or those who do not meet the specific surgical criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive surgical option that improves survival rates and reduces complications for patients with hepatocellular carcinoma.
How similar studies have performed: Other studies have shown promising results for laparoscopic approaches in various surgical contexts, suggesting potential benefits for similar techniques in liver surgery, although this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of HCC is in accordance to the diagnostic criteria for HCC used by the European Association for the Study of the Liver. HCC was diagnosed when the radiologic imaging techniques (spiral contrasted CT scan or contrasted MRI) showed typical features of HCC (contrast enhancement in the arterial phase and rapid wash-out of contrast in the venous or delayed phase) and/or elevated serum alpha fetoprotein (AFP) level. * HCC of maximum diameter up to 10 cm; Single or multiple tumor nodules confined to one liver lobe according to the previous reported series * Major hepatectomy (resection of \> 3 Couinaud's segments) is required as judged by hepatobiliary surgeons * Absence of extrahepatic metastasis or radiological evidence of venous invasion of major portal vein or hepatic vein branches * Child's A liver function * Indocyanine green retention at 15 min (ICG-15) \< 15% * Adequate future liver remnant (image-guided volumetry \> 35% of estimated standard liver volume) * General condition fit for general anaesthesia Exclusion Criteria: * Tumors unfavorable for major hepatectomy (e.g. bilobar tumors, main portal vein tumor thrombus and/or inadequate future liver volume) * Previous treatment for HCC (e.g. transarterial chemoembolization, or chemotherapy) * Tumors require combined hepatectomy and thermal ablation therapy
Where this trial is running
Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Kelvin.K.C Ng, MS, PhD
- Email: kelvinng@surgery.cuhk.edu.hk
- Phone: +852 9124 2695
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.