RecruitingPhase 3NCT04868149

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

Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS: A Randomized Clinical Trial


Sponsor

The University of Hong Kong

Enrollment

40 participants

Start Date

Sep 2, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical approaches — laparoscopic (keyhole) versus open surgery — for a specialized liver operation called ALPPS, which is used when a large portion of the liver needs to be removed due to liver cancer. Researchers want to know which approach leads to better recovery and healthier liver regrowth after the procedure. **You may be eligible if...** - You are 18 or older with a malignant liver tumor requiring an extended liver resection - Your future remaining liver is 30% or less of the total expected liver size - Your liver function test (indocyanine green clearance) is within acceptable range - Your platelet count is above 100,000 and you have mild cirrhosis only (Child A) - Your overall fitness level is acceptable (ECOG score 0–2, anesthesia score under 3) **You may NOT be eligible if...** - You have advanced liver disease with fluid buildup, vein swelling, or mental confusion from liver failure - You have a blood clot in the main portal vein - Your remaining liver is already more than 30% of expected size - Your tumor is larger than 5 cm or you have unusual blood vessel anatomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAssociating liver partition and portal vein ligation for staged hepatectomy (ALPPS)

Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a 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.


Locations(1)

The University of Hong Kong

Hong Kong, Hong Kong

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NCT04868149


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