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Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Phase changed: Phase 3 → not applicable Show 8 more changesShow less
    • Trial completed
    • Final enrollment: 20 participants (planned 40)
    • Study completion date changed from estimate of Dec 31, 2027 to Aug 31, 2026
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 11 of 11 entries
    • Eligibility criteria expanded, about 2 words
  2. Notable Phase: Not applicable to Phase 3v3 Show 4 more changesShow less
    • Enrollment target: 20 to 40
    • Study completion date: Jul 31, 2024 to Dec 31, 2027
    • Interventions: Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) (Procedure) to Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) (Procedure)
    • Site contact updated
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04868149
Lead Sponsor The University of Hong Kong
Conditions
(from sponsor)
Liver Cancer
Related terms Carcinoma, Hepatocellular, Liver Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov