Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection

NCT03630978 | Completed

• 1 other identifier: 2018.01
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Morbidity

  Patients experiencing medical or surgical complications after surgery

  within 90 days after surgery

Secondary Outcomes (2)

• Mortality

  within 90 days after surgery

• Readmission rate

  within 90 days after discharge

Study Arms (1)

Liver resection

Procedure: Liver resection

Interventions

Liver resection PROCEDURE

Major or minor, open or laparoscopic liver resection

Liver resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients undergoing extrahepatic resection
• Patients undergoing cyst fenestration or biopsies without liver resections
• Patients with extrahepatic metastases
• Patients undergoing explorative laparoscopy or laparotomy without parenchymal transection -

Sponsors & Collaborators

• San Camillo Hospital, Rome: lead

Study Sites (1)

San Camillo Hospital

Rome, 00100, Italy

Location

Related Publications (3)

• 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.

  PMID: 29254263 RESULT

• 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.

  PMID: 29149975 RESULT

• 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.

  PMID: 29373365 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Sarcopenia; Postoperative Complications; Carcinoma, Hepatocellular; Focal Nodular Hyperplasia

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Giuseppe Maria Ettorre, Prof

  San Camillo Hospital Spallanzani

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Surgery, Principal Investigator

Study Record Dates

• First Submitted: August 11, 2018
• First Posted: August 15, 2018
• Study Start: July 1, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)