Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) for Colorectal Liver Metastases (CRLM)

Launched by YANHONG DENG · Jan 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a surgical procedure called laparoscopic ALPPS (Associating Liver Partition with Portal Vein Ligation for Staged Hepatectomy) for patients with colorectal liver metastases, which means cancer that has spread to the liver from the colon or rectum. The trial aims to evaluate how safe and practical this minimally invasive technique is compared to traditional surgery, which can come with higher risks. By using laparoscopic methods, doctors hope to reduce complications and improve recovery times for patients.

To be eligible for this trial, participants must be between 18 and 75 years old and have a specific type of colon cancer that has spread to the liver. They should also have good overall health, as determined by a performance scale, and their liver function should be stable. The surgery decision will be made by a team of specialists, including surgeons and oncologists. Participants in the trial can expect to undergo this new surgical approach and will be monitored closely for safety and effectiveness. It’s important to note that the trial is not yet recruiting participants, so it is still in the planning stages.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects \> 18 years \< 75 of age.
• • 2. ECOG performance status 0-1.
• • 3. Histologically confirmed colorectal adenocarcinoma.
• • 4. Imaging (CT or MRI) or pathological confirmation of liver metastasis.
• • 5. Child-Pugh grade A liver function.
• • 6. 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).
• • 7. The indication of surgery is evaluated by a multidisciplinary team attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists.
• Exclusion Criteria:
• • 1. Patients with unresectable extrahepatic metastatic disease (except potentially resectable lung metastases) or primary tumor.
• • 2. Patients with severe concomitant diseases who are intolerance of major liver surgery by the judgment of the surgeon.
• • 3. Diagnosis of other malignant tumors within the past 5 years.
• • 4. Intention to become pregnant during the course of the study.
• • 5. Inability to comply with the study protocol.
• • 6. Previous enrollment in the current study.