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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03132740
Other study ID # 201702
Secondary ID
Status Recruiting
Phase
First received April 5, 2017
Last updated April 17, 2018
Start date March 15, 2017
Est. completion date June 1, 2019

Study information

Verified date March 2018
Source Zhujiang Hospital
Contact Fang Chihua, M.D.;Ph.D
Phone +8613609700805
Email fangch_dr@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhujiang Hospital of The Southern Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 year
Primary 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. 2 year
Secondary Blood routine examination (the 1th, 3 th, 5th, 7th) Hemoglobin (g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%) 2 year
Secondary 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) 2 year
Secondary Stool Routine (the 1th, 3 th,5th, 7th) Defecate occult blood test, Microorganisms (mold, parasites, etc.) 2 year
Secondary 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) 2 year
Secondary 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) 2 year
Secondary 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) 2 year
Secondary Inflammatory biomarkers C-reactive protein, procalcitonin 2 year
Secondary Preoperative viral loading HBV- DNA?HCV- RNA 2 year
Secondary Postoperative results of paraffin wax and immunohistochemical index AFP?Ki67?CK18?CK19?Hepatocyte 2 year
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