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NCT Number: NCT06779474

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location contact

Weidong Pan

CONTACT

[email protected]

86-13925032539

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic ALPPS

Procedure

Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: within the first 90 days after the first stage of ALPPS

    Morbidity and mortality of laparoscopic ALPPS

Secondary outcomes

  1. Resection rate

    Time frame: within the first 14 days after the second stage of ALPPS

    R0 resection rate of laparoscopic ALPPS

  2. Survival

    Time frame: 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.

  3. Future liver remnant after surgery

    Time frame: 3 months

    Future liver remnant volume calculated 3 months after the stage 2 surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Weidong Pan

CONTACT

[email protected]

86-13925032539

Zheyu Zheng

CONTACT

[email protected]

86-13535003060

Sponsors and collaborators

Lead sponsor

Yanhong Deng

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 16, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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