Clinical trial NCT03132740: Impact of Three-dimensional Visualization on Operation Strategy and Complications for Complex Hepatic Carcinoma
Official title: Impact of Three-dimensional Visualization on Operation Strategy and Complications for Complex Hepatic Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Carcinoma
Keywords: Hepatic Carcinoma,Three-dimensional Visualization
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with complex hepatic carcinoma

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years≤ Age ≤70 years
2. Compling with the diagnosis criteria of complex hepatic carcinoma.
3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
4. Preoperative liver function is Child - Pugh grade A or B.
5. The patients are volunteered for the study.

Exclusion Criteria:

1. Patients with mental illness.
2. 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.)
3. The patients refused to take part in the study.
4. There are other co-existed malignant tumors.
5. Benign liver diseases.

Primary outcomes:
measure: Impact on operation strategy of three dimensional visualization technique
timeFrame: 2 year
measure: Impact on complication of three dimensional visualization technique
timeFrame: 2 year
Secondary outcomes:
measure: Blood routine examination (the 1th, 3 th, 5th, 7th)
timeFrame: 2 year
measure: Urine routines (the 1th, 3 th,5th, 7th)
timeFrame: 2 year
measure: Stool Routine (the 1th, 3 th,5th, 7th)
timeFrame: 2 year
measure: Blood biochemistry (the 1th, 3 th,5th, 7th)
timeFrame: 2 year
measure: Tumor marker
timeFrame: 2 year
measure: The blood coagulation function (the 1th, 3th, 5th, 7th)
timeFrame: 2 year
measure: Inflammatory biomarkers
timeFrame: 2 year
measure: Preoperative viral loading
timeFrame: 2 year
measure: Postoperative results of paraffin wax and immunohistochemical index
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of The Southern Medical University
state: Guangdong
Study officials:
References: