Liver TumorNCT02958592
Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study
An observational study of Liver Tumor and Hepatic Fibrosis, run by Sun Yat-sen University.
Trial summary
To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection, using resected tissue pathology as a reference standard. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Tumor, Hepatic Fibrosis
- What is being tested?
- two-dimensional shear-wave elastography (SWE)
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Oct 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with liver tumor intend to hepatectomy
Who may be able to join
- (i) patients with a solid focal liver lesion that was pathologically proven or diagnosed by imaging methods such as conventional US, CT or MR imaging; (ii) patients scheduled to undergo a hepatectomy; (iii) patients with a lesion ≥1.0 cm in diameter.
Who cannot join
- (i) patients with a history of chemotherapy; (ii) patients unable to properly hold their breath.
About this study
To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection, using resected tissue pathology as a reference standard.
- Conditions
- Liver Tumor, Hepatic Fibrosis
- Being tested
- two-dimensional shear-wave elastography (SWE)
- Keywords
- shear-wave elastography, hepatic fibrosis, liver tumor
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-dimensional shear-wave elastography (SWE)Other
performa two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with liver tumor intend to perform hepatectomy Receives: Other: two-dimensional shear-wave elastography (SWE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage of hepatic fibrosis
compare the stage of hepatic fibrosis between SWE test with specimens after surgery
Measured: within the first 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongguo Zhou, Sun Yat-sen University
- Investigators
- Minshan Chen, Study director, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958592
- Sponsor's protocol ID
- 2016-FXY-132
- Status last verified
- Nov 2016
- First submitted
- 5 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Huang Z, Zheng W, Zhang YJ, Xu L, Chen JB, Chen JC, Chen MS, Zhou Z. Assessing Hepatic Fibrosis Using 2-D Shear Wave Elastography in Patients with Liver Tumors: A Prospective Single-Center Study. Ultrasound Med Biol. 2017 Nov;43(11):2522-2529. doi: 10.1016/j.ultrasmedbio.2017.07.003. Epub 2017 Aug 12.
PubMed 28807448
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study
- ClinicalTrials.gov ID
- NCT02958592
- Acronym / sponsor ID
- 2016-FXY-132
- Conditions
- Liver Tumor, Hepatic Fibrosis
- Keywords
- shear-wave elastography, hepatic fibrosis, liver tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 Nov 2016 (estimated)
- 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.
To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection, using resected tissue pathology as a reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: two-dimensional shear-wave elastography (SWE)patients with liver tumor intend to perform hepatectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with liver tumor intend to hepatectomy
Key inclusion criteria (1 listed)
- (i) patients with a solid focal liver lesion that was pathologically proven or diagnosed by imaging methods such as conventional US, CT or MR imaging; (ii) patients scheduled to undergo a hepatectomy; (iii) patients with a lesion ≥1.0 cm in diameter.
Key exclusion criteria (1 listed)
- (i) patients with a history of chemotherapy; (ii) patients unable to properly hold their breath.
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 |
|---|---|---|
| two-dimensional shear-wave elastography (SWE)performa two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection | Other | study group |
Primary outcome
Stage of hepatic fibrosis
Time frame: within the first 7 days after surgery
compare the stage of hepatic fibrosis between SWE test with specimens after surgery
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 8 Nov 2016.
- Derived from this study: PubMed 28807448Huang Z, Zheng W, Zhang YJ, Xu L, Chen JB, Chen JC, Chen MS, Zhou Z. Assessing Hepatic Fibrosis Using 2-D Shear Wave Elastography in Patients with Liver Tumors: A Prospective Single-Center Study. Ultrasound Med Biol. 2017 Nov;43(11):2522-2529. doi: 10.1016/j.ultrasmedbio.2017.07.003. Epub 2017 Aug 12.
- 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.
Minshan Chen study director
Sun Yat-Sen University Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Tumor and Hepatic Fibrosis, run by Sun Yat-sen University.
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 1 inclusion and 1 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Stage of hepatic fibrosis (time frame: within the first 7 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 NCT02958592, which also lists 1 linked publication.
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 8 Nov 2016.