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

Last updated: April 15, 2025
Sponsor: San Camillo Hospital, Rome
Overall Status: Completed

Phase

N/A

Condition

Sarcopenia

Surgery

Digestive System Neoplasms

Treatment

Nutrition

Exercise

Clinical Study ID

NCT05281211
2022.01
  • Ages 18-90
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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

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 couldnot be waited (i.e., large HCCs on healthy livers not requiring preoperative portalvein occlusion, CRLM without preoperative administration of anti-VEGF drug whotherefore 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.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Nutrition
Phase:
Study Start date:
March 15, 2022
Estimated Completion Date:
April 15, 2025

Connect with a study center

  • San Camillo Forlanini

    Roma, RM 00135
    Italy

    Site Not Available

  • San Camillo Hospital

    Rome, 00100
    Italy

    Site Not Available

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