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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2025-04-15

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.

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Detailed Description

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Conditions

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Liver Cancer Surgery Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Preoperative Nutrition+Exercise

Preoperative nutrition and exercise pre-habilitation followed by major liver resection.

Group Type EXPERIMENTAL

Nutrition

Intervention Type DIETARY_SUPPLEMENT

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

Exercise

Intervention Type BEHAVIORAL

6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily

Upfront Surgery

Upfront major liver resection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutrition

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

Intervention Type DIETARY_SUPPLEMENT

Exercise

6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No