Impact of Three-dimensional Visualization on Operation Strategy and Complications for Complex Hepatic Carcinoma

• Conditions: Hepatic Carcinoma

• Registration Number: NCT03132740
• Lead Sponsor: Zhujiang Hospital

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.

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-28
• Status Verified: 2018-03
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact on operation strategy of three dimensional visualization technique	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	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.

Secondary Outcome Measures

Name	Time	Method
Blood routine examination (the 1th, 3 th, 5th, 7th)	2 year	Hemoglobin (g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%)
Urine routines (the 1th, 3 th,5th, 7th)	2 year	Urine specific gravity, urine protein(mg/dl), urine sugar(mmol/L), leukocytes in urine(number/ul), urine erythrocyte(number/ul)
Stool Routine (the 1th, 3 th,5th, 7th)	2 year	Defecate occult blood test, Microorganisms (mold, parasites, etc.)
Tumor marker	2 year	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)
Postoperative results of paraffin wax and immunohistochemical index	2 year	AFP、Ki67、CK18、CK19、Hepatocyte
Blood biochemistry (the 1th, 3 th,5th, 7th)	2 year	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)
Inflammatory biomarkers	2 year	C-reactive protein, procalcitonin
The blood coagulation function (the 1th, 3th, 5th, 7th)	2 year	prothrombin time (PT, s), partial thromboplastin time (APTT), international normalized ratio (INR), plasma prothrombin activity (PTA, %), fibrinogen (FIB, g/L), d-dimer(mg/L)
Preoperative viral loading	2 year	HBV- DNA、HCV- RNA

Trial Locations

Locations (1)

Zhujiang Hospital of The Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China