MedDataX Logo

Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection

NCT ID: NCT03630978

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

251 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Neoplasms Sarcopenia Postoperative Complications

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hepatocellular carcinoma colorectal liver metastases non-colorectal liver metastases focal nodular hyperplasia liver hemangioma liver cysts surgical morbidity surgical mortality sarcopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Liver resection

Liver resection

Intervention Type PROCEDURE

Major or minor, open or laparoscopic liver resection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Liver resection

Major or minor, open or laparoscopic liver resection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

San Camillo Hospital, Rome

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giammauro Berardi

Resident in Surgery, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giuseppe Maria Ettorre, Prof

Role: STUDY_DIRECTOR

San Camillo Hospital Spallanzani

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

San Camillo Hospital

Rome, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 29254263 (View on PubMed)

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.

Reference Type RESULT
PMID: 29149975 (View on PubMed)

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.

Reference Type RESULT
PMID: 29373365 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018.01

Identifier Type: -

Identifier Source: org_study_id