Clinical trial NCT05281211: Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients
Official title: Nutrition and EXercise Prehabilitation to Reduce Morbidity (NEXPREM) Following Major Liver Surgery in Sarcopenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Surgery
Sarcopenia
Keywords: sarcopenia
liver cancer
liver surgery
hepatectomy
Lead sponsor: San Camillo Hospital, Rome
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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 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.

Primary outcomes:
measure: Number of participants experiencing 90 day morbidity
timeFrame: 90 days
Secondary outcomes:
measure: Number of participants experiencing 90 days postoperative major complications according to Clavien-Dindo classification
timeFrame: 90 days
measure: Number of participants experiencing 90 days postoperative mortality.
timeFrame: 90 days
measure: Number of participants being readmitted within 90 days of surgery.
timeFrame: 90 days
measure: Number of participants being Sarcopenic after 6 weeks of prehabilitation.
timeFrame: 6 weeks
measure: Number of participants Alive ( Overall Survival)
timeFrame: 3 years
measure: Number of participants being disease free (Disease free survival)
timeFrame: 3 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Camillo Forlanini
state: RM
city: Rome
country: Italy
facility: San Camillo Hospital
Study officials:
References: