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

Yanhong Deng

Status: Not yet enrolling

Conditions: Colorectal Liver Metastases

Treatments: Procedure: Laparoscopic ALPPS

Study type: Observational

Funder types: Other

Identifiers

NCT06779474

2022ZSLYEC-130

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Laparoscopic ALPPS group

Description:

CRLM patients with insufficient future liver remnant who are performed laparoscopic associating liver partition with portal vein ligation for staged hepatectomy

Treatment:

Procedure: Laparoscopic ALPPS