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

Surgery Clinical Trial

— NEXPREM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281211
• Other study ID #: 2022.01
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: February 15, 2025

Study information

• Verified date: April 2024
• Source: San Camillo Hospital, Rome
• Contact: Giammauro BERARDI
• Phone: 0658705816
• Email: gberardi1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Sarcopenia
• Surgery

Intervention

Dietary Supplement:
• 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

Behavioral:
• Exercise
6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily

Locations

Country	Name	City	State
Italy	San Camillo Forlanini	Roma	RM
Italy	San Camillo Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
San Camillo Hospital, Rome

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing 90 day morbidity	Patients experiencing complications within 90 days of surgery	90 days
Secondary	Number of participants experiencing 90 days postoperative major complications according to Clavien-Dindo classification		90 days
Secondary	Number of participants experiencing 90 days postoperative mortality.		90 days
Secondary	Number of participants being readmitted within 90 days of surgery.		90 days
Secondary	Number of participants being Sarcopenic after 6 weeks of prehabilitation.		6 weeks
Secondary	Number of participants Alive ( Overall Survival)		3 years
Secondary	Number of participants being disease free (Disease free survival)		3 years