Clinical trial · Interventional
Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients
Nutrition and EXercise Prehabilitation to Reduce Morbidity (NEXPREM) Following Major Liver Surgery in Sarcopenic Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Sarcopenia | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
| Nutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preoperative Nutrition+Exercise
- description
- Preoperative nutrition and exercise pre-habilitation followed by major liver resection.
- interventionNames
- Dietary Supplement: Nutrition
- Behavioral: Exercise
- type
- NO_INTERVENTION
- label
- Upfront Surgery
- description
- Upfront major liver resection.
Primary outcomes (1)
- measure
- Number of participants experiencing 90 day morbidity
- timeFrame
- 90 days
- description
- Patients experiencing complications within 90 days of surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBerardi G, Cucchetti A, Colasanti M, Angrisani M, Moschetta G, Chiappori D, Marini A, Antonelli G, Ferretti S, Meniconi RL, Guglielmo N, Mariano G, Usai S, Ettorre GM. Prehabilitation With Exercise and Nutrition to Reduce Morbidity of Major Hepatectomy in Patients With Sarcopenia: The PREHEP Randomized Clinical Trial. JAMA Surg. 2025 Oct 1;160(10):1068-1075. doi: 10.1001/jamasurg.2025.3102. PMID 40864449