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NCT06779474 | NOT YET RECRUITING | Colorectal Liver Metastases

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

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Information provided by (Responsible Party):

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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.

Condition or disease

Colorectal Liver Metastases

Intervention/treatment

Laparoscopic ALPPS

Study Type : OBSERVATIONAL
Estimated Enrollment : 30 participants
Official Title : Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) for Colorectal Liver Metastases (CRLM)
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2030-05-01
Estimated Study Completion Date : 2030-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) for Colorectal Liver Metastases (CRLM)

Location Details

NCT06779474

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How to Participate

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Locations

Not yet recruiting

China, Guangdong

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510655