Hepatic CarcinomaNCT03132740
Impact of Three-dimensional Visualization on Operation Strategy and Complications for Complex Hepatic Carcinoma
An observational study of Hepatic Carcinoma, run by Zhujiang Hospital at 1 site in China.
Trial summary
The aim of the multi-centre study is to evaluate correctly the impact of three dimensional visualization on operation strategy and complications for complex hepatic carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Carcinoma
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2017to 1 Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with complex hepatic carcinoma
Who may be able to join
- 18 years≤ Age ≤70 years
- Compling with the diagnosis criteria of complex hepatic carcinoma.
- Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
- Preoperative liver function is Child - Pugh grade A or B.
- The patients are volunteered for the study.
Who cannot join
- Patients with mental illness.
- Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
- The patients refused to take part in the study.
- There are other co-existed malignant tumors.
- Benign liver diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of The Southern Medical University
Guangzhou, Guangdong, 510282
Chihua Fang, MD, (+86)2062782568, s_mountain@126.com
Qingshan Chen, MM, (+86)2062782568, s_mountain@126.com
About this study
The aim of the multi-centre study is to evaluate correctly the impact of three dimensional visualization on operation strategy and complications for complex hepatic carcinoma.
Read the detailed description
Because of the complexity of complex hepatic carcinoma,the limitations of 2D images of CT/MRI and the uncertainty of surgeons'experience, it is difficult for the surgeons to diagnosis and assess the operation strategy accurately based on traditional 2D imaging(CT/MRI).The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional visualization on operation strategy and complications for complex hepatic carcinoma.
- Conditions
- Hepatic Carcinoma
- Keywords
- Hepatic Carcinoma,Three-dimensional Visualization
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on operation strategy of three dimensional visualization technique
Firstly, the operation strategies based on original CT or MRI image data will be made by the team, Secondly, the operation strategies based on three dimensional reconstruction models will be made by the team, then, actually surgical strategies will be recorded. The change of operation strategy will be assessed by comparing the strategy of the 2D model and 3D model. The change rate of operation strategy will be recorded and presented as percentage.
Measured: 2 year
Impact on complication of three dimensional visualization technique
The complications are refer to the classification of Clavien-Dindo, including postoperative bleeding, biliary fistula, ascites, postoperative liver failure, renal dysfunction, pleural effusion, abdominal cavity infection, abdominal abscess, incision infection, the occurrence cases of each complication (number) will be recorded.
Measured: 2 year
Secondary outcomes (9)
Blood routine examination (the 1th, 3 th, 5th, 7th)
Hemoglobin (g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%)
Measured: 2 year
Urine routines (the 1th, 3 th,5th, 7th)
Urine specific gravity, urine protein(mg/dl), urine sugar(mmol/L), leukocytes in urine(number/ul), urine erythrocyte(number/ul)
Measured: 2 year
Stool Routine (the 1th, 3 th,5th, 7th)
Defecate occult blood test, Microorganisms (mold, parasites, etc.)
Measured: 2 year
Blood biochemistry (the 1th, 3 th,5th, 7th)
Serum albumin(g/L), serum pre-albumin(g/L), serum globulin(g/L), total bilirubin(µmol/L), direct bilirubin(µmol/L),serum glutamic-oxaloacetic transaminase (AST, IU/L), serum glutamic pyruvic transaminase (ALT, IU/L), alkaline phosphatase (ALP, IU/L), gamma glutamyl transpeptidase（r-GGT, IU/L） ,Serum creatinine(µmol/L), Urea(mmol/L), Blood sugar(mmol/L)
Measured: 2 year
Tumor marker
Alpha fetoprotein(AFP, ng/L), Carbohydrate antigen-199(CA-199, ku/L), Carbohydrate antigen-125(CA-125, ku/L), Carcinoembryonic antigen (CEA, ng/L), Carbohydrate antigen-153(CA-153, ku/L)
Measured: 2 year
The blood coagulation function (the 1th, 3th, 5th, 7th)
prothrombin time (PT, s), partial thromboplastin time (APTT), international normalized ratio (INR), plasma prothrombin activity (PTA, %), fibrinogen (FIB, g/L), d-dimer(mg/L)
Measured: 2 year
Inflammatory biomarkers
C-reactive protein, procalcitonin
Measured: 2 year
Preoperative viral loading
HBV- DNA、HCV- RNA
Measured: 2 year
Postoperative results of paraffin wax and immunohistochemical index
AFP、Ki67、CK18、CK19、Hepatocyte
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start15 Mar 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132740
- Sponsor's protocol ID
- 201702
- Status last verified
- Mar 2018
- First submitted
- 5 Apr 2017
- Last updated
- 19 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Three-dimensional Visualization on Operation Strategy and Complications for Complex Hepatic Carcinoma
- ClinicalTrials.gov ID
- NCT03132740
- Acronym / sponsor ID
- 201702
- Conditions
- Hepatic Carcinoma
- Keywords
- Hepatic Carcinoma,Three-dimensional Visualization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 28 Apr 2017 (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 aim of the multi-centre study is to evaluate correctly the impact of three dimensional visualization on operation strategy and complications for complex hepatic carcinoma.
Detailed description
Because of the complexity of complex hepatic carcinoma,the limitations of 2D images of CT/MRI and the uncertainty of surgeons'experience, it is difficult for the surgeons to diagnosis and assess the operation strategy accurately based on traditional 2D imaging(CT/MRI).The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional visualization on operation strategy and complications for complex hepatic carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with complex hepatic carcinoma
Key inclusion criteria (5 listed)
- 18 years≤ Age ≤70 years
- Compling with the diagnosis criteria of complex hepatic carcinoma.
- Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
- Preoperative liver function is Child - Pugh grade A or B.
- The patients are volunteered for the study.
Key exclusion criteria (5 listed)
- Patients with mental illness.
- Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
- The patients refused to take part in the study.
- There are other co-existed malignant tumors.
- Benign liver diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact on operation strategy of three dimensional visualization technique
Time frame: 2 year
Firstly, the operation strategies based on original CT or MRI image data will be made by the team, Secondly, the operation strategies based on three dimensional reconstruction models will be made by the team, then, actually surgical strategies will be recorded. The change of operation strategy will be assessed by comparing the strategy of the 2D model and 3D model. The change rate of operation strategy will be recorded and presented as percentage.
Impact on complication of three dimensional visualization technique
Time frame: 2 year
The complications are refer to the classification of Clavien-Dindo, including postoperative bleeding, biliary fistula, ascites, postoperative liver failure, renal dysfunction, pleural effusion, abdominal cavity infection, abdominal abscess, incision infection, the occurrence cases of each complication (number) will be recorded.
9 secondary outcomes
Blood routine examination (the 1th, 3 th, 5th, 7th)
Time frame: 2 year
Urine routines (the 1th, 3 th,5th, 7th)
Time frame: 2 year
Stool Routine (the 1th, 3 th,5th, 7th)
Time frame: 2 year
Blood biochemistry (the 1th, 3 th,5th, 7th)
Time frame: 2 year
Tumor marker
Time frame: 2 year
The blood coagulation function (the 1th, 3th, 5th, 7th)
Time frame: 2 year
Inflammatory biomarkers
Time frame: 2 year
Preoperative viral loading
Time frame: 2 year
Postoperative results of paraffin wax and immunohistochemical index
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
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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.
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 Hepatic Carcinoma, run by Zhujiang Hospital at 1 site in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Apr 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Chihua, M.D.;Ph.D (+8613609700805, fangch_dr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on operation strategy of three dimensional visualization technique (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2018.