Asia-Pacific multicentre randomized trial of laparoscopic versus open major hepatectomy for hepatocellular carcinoma (AP-LAPO trial).

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  • Additional Information
    • Source:
      Publisher: Oxford University Press Country of Publication: England NLM ID: 101722685 Publication Model: Print Cited Medium: Internet ISSN: 2474-9842 (Electronic) Linking ISSN: 24749842 NLM ISO Abbreviation: BJS Open Subsets: MEDLINE
    • Publication Information:
      Publication: 2021- : [Oxford] : Oxford University Press
      Original Publication: [Chichester, West Sussex, England] : John Wiley & Sons Ltd., [2017]-
    • Subject Terms:
      Carcinoma, Hepatocellular*/surgery ; Liver Neoplasms*/surgery ; Laparoscopy*/adverse effects; Humans ; Hepatectomy ; Neoplasm Recurrence, Local/epidemiology ; Quality of Life ; Asia/epidemiology
    • Abstract:
      Background: Hepatocellular carcinoma is the sixth most common malignancy in the world. Major hepatectomy (resection of greater than or equal to three liver segments) is needed if a tumour is large or close to major blood vessels. Despite low mortality, open major hepatectomy is associated with high rates of tumour recurrence that limits survival. Laparoscopic major hepatectomy has been proposed as an alternative approach with potential oncological benefits. This study compares laparoscopic major hepatectomy with open major hepatectomy for hepatocellular carcinoma in a randomized trial.
      Methods: The Asia-Pacific multicentre randomized trial of laparoscopic versus open major hepatectomy for hepatocellular carcinoma (AP-LAPO trial) is an open-labelled multicentre randomized trial to be conducted in five centres in the Asia-Pacific region. The study will test the hypothesis that laparoscopic major hepatectomy for hepatocellular carcinoma is associated with less tumour recurrence and better survival compared with open major hepatectomy; the primary outcome being 2-year recurrence-free survival. Secondary outcomes include hospital mortality, postoperative complications according to the Clavien-Dindo classification, time to functional recovery, quality of life, long-term survival, and postoperative serum surgical stress-related cytokines.
      Results and Conclusion: The AP-LAPO trial will determine whether laparoscopic major hepatectomy offers oncological benefits to patients with hepatocellular carcinoma compared with open major hepatectomy.
      Registration Number: NCT04852211 (http://www.clinicaltrials.gov) registered on 21 April 2021.
      Protocol Version: AP-LAPO trial version 01 (1 December 2021).
      (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)
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    • Grant Information:
      Health and Medical Research Fund; 08190446 Health Bureau of Hong Kong Special Administrative Region of China
    • Molecular Sequence:
      ClinicalTrials.gov NCT04852211
    • Publication Date:
      Date Created: 20230228 Date Completed: 20230301 Latest Revision: 20230320
    • Publication Date:
      20250114
    • Accession Number:
      PMC9970867
    • Accession Number:
      10.1093/bjsopen/zrac166
    • Accession Number:
      36849753