Clinical trial NCT03630978: Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection
Official title: The Impact of Sarcopenia, Body Composition and Other Biometric Parameters on the Postoperative Outcomes of Patients Undergoing Liver Resection for Different Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Neoplasms
Sarcopenia
Postoperative Complications
Keywords: hepatocellular carcinoma
colorectal liver metastases
non-colorectal liver metastases
focal nodular hyperplasia
liver hemangioma
liver cysts
surgical morbidity
surgical mortality
sarcopenia
Lead sponsor: San Camillo Hospital, Rome
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing liver resection for benign and malignant indications with CT scan imaging availability within 30 days before surgery.

Of all the patients included in the study muscle function tests will be collected including handgrip strength, gait speed and fat composition.

Preoperative antropometric, biochemical and disease presentation characteristics will be collected as well as operative details and postoperative outcomes.

Brief summary: The investigators will investigate the impact of different biometric parameters (Body mass index, sarcopenia, lean muscle mass, hand-grip strength, gait speed, fat composition) on the postoperative outcomes of patients undergoing liver resections.

Major and minor liver resections will be considered as well as open and minimally invasive techniques.

Benign and malignant indications will be included. Patients characteristics and perioperative variables will be considered for analysis.

Short-term outcomes will be evaluated focusing on 90-days morbidity and mortality and readmission rate.

Detailed description: According to the null hypothesis, no difference in postoperative morbidity between the two groups would be expected. To calculate sample size, a 42% morbidity rate would be expected in sarcopenic patients while a 22% rate would be expected in the non-sarcopenic group. Considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve statistical significance was 224 subjects. Considering a 10% drop-out rate of patients undergoing explorative laparoscopy or laparotomy without parenchymal resection a total of 249 patients will be required for completion of the study

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing open or laparoscopic liver resection
2. Patients undergoing major or minor liver resection
3. Patients undergoing liver resection for primary or secondary liver malignancies
4. Patients undergoing liver resections for benign diseases (cysts, adenoma, focal nodular hyperplasia, hemangioma) -

Exclusion Criteria:

1. Patients undergoing extrahepatic resection
2. Patients undergoing cyst fenestration or biopsies without liver resections
3. Patients with extrahepatic metastases
4. Patients undergoing explorative laparoscopy or laparotomy without parenchymal transection -

Primary outcomes:
measure: Morbidity
timeFrame: within 90 days after surgery
Secondary outcomes:
measure: Mortality
timeFrame: within 90 days after surgery
measure: Readmission rate
timeFrame: within 90 days after discharge
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Camillo Hospital
Study officials:
affiliation: San Camillo Hospital Spallanzani
name: Giuseppe Maria Ettorre, Prof
role: STUDY_DIRECTOR
References:
citation: Zhang G, Meng S, Li R, Ye J, Zhao L. Clinical significance of sarcopenia in the treatment of patients with primary hepatic malignancies, a systematic review and meta-analysis. Oncotarget. 2017 Jul 28;8(60):102474-102485. doi: 10.18632/oncotarget.19687. eCollection 2017 Nov 24.
citation: Harimoto N, Yoshizumi T, Izumi T, Motomura T, Harada N, Itoh S, Ikegami T, Uchiyama H, Soejima Y, Nishie A, Kamishima T, Kusaba R, Shirabe K, Maehara Y. Clinical Outcomes of Living Liver Transplantation According to the Presence of Sarcopenia as Defined by Skeletal Muscle Mass, Hand Grip, and Gait Speed. Transplant Proc. 2017 Nov;49(9):2144-2152. doi: 10.1016/j.transproceed.2017.09.017.
citation: Simonsen C, de Heer P, Bjerre ED, Suetta C, Hojman P, Pedersen BK, Svendsen LB, Christensen JF. Sarcopenia and Postoperative Complication Risk in Gastrointestinal Surgical Oncology: A Meta-analysis. Ann Surg. 2018 Jul;268(1):58-69. doi: 10.1097/SLA.0000000000002679.