Status:
COMPLETED
Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients
Lead Sponsor:
San Camillo Hospital, Rome
Conditions:
Liver Cancer
Surgery
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
NEXPREM is a single-center non-blinded randomized controlled trial investigating preoperative exercise and nutrition for sarcopenic patients in major hepatic surgery for liver malignancies. Patients w...
Eligibility Criteria
Inclusion
- Age \>18.
- Sarcopenic patients diagnosed by both qualitative and quantitative analysis.
- Patients with primary or secondary liver malignancies.
- Patients undergoing major liver resections intended as 3 or more contiguous segments
- Patients undergoing open, laparoscopic, or robotic resections.
Exclusion
- Minor liver resections intended as less than 3 contiguous segments.
- Patients with intrahepatic, hilar, or extrahepatic cholangiocarcinomas.
- Patients with liver tumors for whom 6 weeks interval from diagnosis to surgery could not be waited (i.e., large HCCs on healthy livers not requiring preoperative portal vein occlusion, CRLM without preoperative administration of anti-VEGF drug who therefore do not require 6 weeks of chemotherapy washout)
- Patients with benign liver lesions.
- Patients undergoing extrahepatic liver resections.
- Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) procedure.
- Patients with physical disabilities, unable to exercise.
- Patients with inadequate kidney function.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05281211
Start Date
March 15 2022
End Date
April 15 2025
Last Update
April 18 2025
Active Locations (2)
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1
San Camillo Hospital
Rome, Italy, Italy, 00100
2
San Camillo Forlanini
Roma, RM, Italy, 00135