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

NCT06779474 | Not Yet Recruiting

• 1 other identifier: 2022ZSLYEC-130
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Liver Metastases

Keywords

Colorectal liver metastases; Associating liver partition and portal vein ligation for staged hepatectomy; Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  Morbidity and mortality of laparoscopic ALPPS

  within the first 90 days after the first stage of ALPPS

Secondary Outcomes (3)

• Resection rate

  within the first 14 days after the second stage of ALPPS

• Survival

  3 years

• Future liver remnant after surgery

  3 months

Study Arms (1)

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

Interventions

Laparoscopic ALPPS PROCEDURE

Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy

Laparoscopic ALPPS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female subjects \> 18 years \< 75 of age.
• ECOG performance status 0-1.
• Histologically confirmed colorectal adenocarcinoma.
• 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.

You may not qualify if:

• 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.
• Previous enrollment in the current study.

Sponsors & Collaborators

• Yanhong Deng: lead

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Central Study Contacts

Weidong Pan

CONTACT

86-13925032539; panwd@mail.sysu.edu.cn

Zheyu Zheng

CONTACT

86-13535003060; doctorfishzzy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Professor

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 16, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)