Liver NeoplasmsNCT03630978
Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection
An observational study of Liver Neoplasms and Sarcopenia, run by San Camillo Hospital, Rome at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Neoplasms, Sarcopenia, Postoperative Complications
- What is being tested?
- Liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 251 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2018to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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) -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Sarcopenia, Body Composition and Other Biometric Parameters on the Postoperative Outcomes of Patients Undergoing Liver Resection for Different Indications
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.
Read the 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
- Conditions
- Liver Neoplasms, Sarcopenia, Postoperative Complications
- Being tested
- Liver resection
- Keywords
- hepatocellular carcinoma, colorectal liver metastases, non-colorectal liver metastases, focal nodular hyperplasia, liver hemangioma, liver cysts, surgical morbidity, surgical mortality, sarcopenia
- Medical subject headings
- Liver Neoplasms, Sarcopenia, Postoperative Complications, Carcinoma, Hepatocellular, Focal Nodular Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Major or minor, open or laparoscopic liver resection
| Study group | Role | What they receive |
|---|---|---|
| Liver resection | Not described Receives: Procedure: Liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Patients experiencing medical or surgical complications after surgery
Measured: within 90 days after surgery
Secondary outcomes (2)
Mortality
Patients dying after surgery
Measured: within 90 days after surgery
Readmission rate
patients readmitted to hospital after discharge
Measured: within 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Jul 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Camillo Hospital, Rome
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giammauro Berardi, San Camillo Hospital, Rome
- Investigators
- Giuseppe Maria Ettorre, Prof, Study director, San Camillo Hospital Spallanzani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630978
- Sponsor's protocol ID
- 2018.01
- Status last verified
- Dec 2019
- First submitted
- 11 Aug 2018
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29254263Harimoto 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.
PubMed 29149975Simonsen 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.
PubMed 29373365
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sarcopenia, Body Composition and Other Biometric Parameters on the Postoperative Outcomes of Patients Undergoing Liver Resection for Different Indications
- ClinicalTrials.gov ID
- NCT03630978
- Acronym / sponsor ID
- 2018.01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- San Camillo Hospital, RomeUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver resection | – | Procedure: Liver resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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) -
Key exclusion criteria (4 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver resectionMajor or minor, open or laparoscopic liver resection | Procedure or surgery | Liver resection |
Primary outcome
Morbidity
Time frame: within 90 days after surgery
Patients experiencing medical or surgical complications after surgery
2 secondary outcomes
Mortality
Time frame: within 90 days after surgery
Readmission rate
Time frame: within 90 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Results publication: PubMed 29254263Zhang 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.
- Results publication: PubMed 29149975Harimoto 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.
- Results publication: PubMed 29373365Simonsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Maria Ettorre, Prof study director
San Camillo Hospital Spallanzani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms and Sarcopenia, run by San Camillo Hospital, Rome at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: within 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630978, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.