Colorectal Liver Metastases
Conditions
Keywords
Colorectal liver metastases, Associating liver partition and portal vein ligation for staged hepatectomy, Laparoscopic surgery
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.
Interventions
PROCEDURELaparoscopic ALPPS
Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy
Sponsors
Yanhong Deng
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | within the first 90 days after the first stage of ALPPS | Morbidity and mortality of laparoscopic ALPPS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resection rate | within the first 14 days after the second stage of ALPPS | R0 resection rate of laparoscopic ALPPS |
| Survival | 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. |
| Future liver remnant after surgery | 3 months | Future liver remnant volume calculated 3 months after the stage 2 surgery |
Countries
China
Contacts
Primary ContactWeidong Pan
Backup ContactZheyu Zheng
Outcome results
None listed