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Not yet recruiting NCT06779474

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

— Observational Colorectal Liver Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic ALPPS.
Who it may be relevant to
Registry conditions: Colorectal Liver Metastases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Laparoscopic ALPPS
    Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy

Primary outcome measures

  • Incidence of Adverse Events [Time frame: within the first 90 days after the first stage of ALPPS]
Secondary outcome measures (3)
  • Resection rate [Time frame: within the first 14 days after the second stage of ALPPS]
  • Survival [Time frame: 3 years]
  • Future liver remnant after surgery [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • the Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06779474 · 2022ZSLYEC-130

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗