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

Not yet recruiting

• Conditions: Colorectal Liver Metastases

• Registration Number: NCT06779474
• Lead Sponsor: Yanhong Deng

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-11
• Study First Submitted QC: 2025-01-11
• Study First Posted: 2025-01-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-17
• Study Start: 2025-05-01
• Primary Completion: 2030-05-01
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	within the first 90 days after the first stage of ALPPS	Morbidity and mortality of laparoscopic ALPPS

Secondary Outcome Measures

Name	Time	Method
Resection rate	within the first 14 days after the second stage of ALPPS	R0 resection rate of laparoscopic ALPPS
Survival	3 years	follow-up after the surgery every 3 months, to evaluate recurrence, death, analysis 1-year, 3-year overall survival rates，disease-free survival rates and recurrence rate.
Future liver remnant after surgery	3 months	Future liver remnant volume calculated 3 months after the stage 2 surgery

Trial Locations

Locations (1)

the Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China