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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Liver Metastases
• Intervention / Treatment: Procedure: Laparoscopic ALPPS

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Weidong Pan; Phone Number: 86-13925032539; Email: panwd@mail.sysu.edu.cn
• Study Contact Backup: Name: Zheyu Zheng; Phone Number: 86-13535003060; Email: doctorfishzzy@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • The sixth affiliated hospital of Sun Yat-Sen University
      • Contact: Weidong Pan; Phone Number: 86-13925032539; Email: panwd@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants are hospitalized at the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic ALPPS group; CRLM patients with insufficient future liver remnant who are performed laparoscopic associating liver partition with portal vein ligation for staged hepatectomy	Procedure: Laparoscopic ALPPS; Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Morbidity and mortality of laparoscopic ALPPS	within the first 90 days after the first stage of ALPPS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Future liver remnant after surgery	Future liver remnant volume calculated 3 months after the stage 2 surgery	3 months
Resection rate	R0 resection rate of laparoscopic ALPPS	within the first 14 days after the second stage of ALPPS
Survival	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.	3 years

Collaborators and Investigators

• Sponsor: Yanhong Deng

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: January 11, 2025
• First Submitted That Met QC Criteria: January 11, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 13, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Colorectal liver metastases; Associating liver partition and portal vein ligation for staged hepatectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: 2022ZSLYEC-130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No