Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients

Study Overview
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Brief Summary
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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 with sarcopenia undergoing major hepatectomies have high rates of postoperative complications. Previous studies have demonstrated that preoperative rehabilitation with exercise and nutrition may help reduce the negative impact of sarcopenia. The investigator's hypothesis is that preoperative nutrition and exercise may reduce complications in sarcopenic patients undergoing major hepatectomies. Sarcopenic patients at diagnosis will be randomized in Group A undergoing upfront surgery and Group B undergoing preoperative rehabilitation. Outcome will be overall 90 day morbidity.

Official Title
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Nutrition and EXercise Prehabilitation to Reduce Morbidity (NEXPREM) Following Major Liver Surgery in Sarcopenic Patients

Conditions
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Liver Cancer, Surgery, Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Nutrition
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative Nutrition+Exercise<br>Preoperative nutrition and exercise pre-habilitation followed by major liver resection. | Dietary Supplement: Nutrition<br>* 6 weeks nutrition implementation in the form of branched chain amino acids and immune-system boosters twice daily for 4 weeks and once daily for 2 weeks<br>Behavioral: Exercise<br>* 6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily<br>|
| No Intervention: Upfront Surgery<br>Upfront major liver resection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing 90 day morbidity | Patients experiencing complications within 90 days of surgery | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing 90 days postoperative major complications according to Clavien-Dindo classification |  | 90 days | 
| Number of participants experiencing 90 days postoperative mortality. |  | 90 days | 
| Number of participants being readmitted within 90 days of surgery. |  | 90 days | 
| Number of participants being Sarcopenic after 6 weeks of prehabilitation. |  | 6 weeks | 
| Number of participants Alive ( Overall Survival) |  | 3 years | 
| Number of participants being disease free (Disease free survival) |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcopenia, liver cancer, liver surgery, hepatectomy