Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS)… (NCT06779474) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) for Colorectal Liver Metastases (CRLM)
China30 participantsStarted 2025-05-01
Plain-language summary
Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a procedure used for patients with initially unresectable colorectal liver metastases (CRLM). However, the procedure has been reported to be associated with high morbidity and mortality. Laparoscopic ALPPS has recently been reported as a minimally invasive technique that reduces perioperative risks. This study aimed to assess the safety and feasibility of full laparoscopic ALPPS in patients with CRLM.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female subjects \> 18 years \< 75 of age.
✓. Imaging (CT or MRI) or pathological confirmation of liver metastasis.
✓. Child-Pugh grade A liver function.
✓. FLR/sTLV (standardized total liver volume) \< 30% (patients without underlying liver diseases)or \< 40% (patients with liver diseases, such as hepatic steatosis, cirrhosis, or liver damage after chemotherapy).
✓. The indication of surgery is evaluated by a multidisciplinary team attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists.
Exclusion criteria
✕. Patients with unresectable extrahepatic metastatic disease (except potentially resectable lung metastases) or primary tumor.
✕. Patients with severe concomitant diseases who are intolerance of major liver surgery by the judgment of the surgeon.
✕. Diagnosis of other malignant tumors within the past 5 years.
✕. Intention to become pregnant during the course of the study.
✕. Inability to comply with the study protocol.
✕
What they're measuring
1
Incidence of Adverse Events
Timeframe: within the first 90 days after the first stage of ALPPS