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Clinical Trials/NCT03132740
NCT03132740
Unknown
Not Applicable

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

Zhujiang Hospital1 site in 1 country2,000 target enrollmentMarch 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatic Carcinoma
Sponsor
Zhujiang Hospital
Enrollment
2000
Locations
1
Primary Endpoint
Impact on operation strategy of three dimensional visualization technique
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2017
End Date
June 1, 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zhujiang Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Blood routine examination (the 1th, 3 th, 5th, 7th)(2 year)
  • Urine routines (the 1th, 3 th,5th, 7th)(2 year)
  • Stool Routine (the 1th, 3 th,5th, 7th)(2 year)
  • Tumor marker(2 year)
  • Postoperative results of paraffin wax and immunohistochemical index(2 year)
  • Blood biochemistry (the 1th, 3 th,5th, 7th)(2 year)
  • Inflammatory biomarkers(2 year)
  • The blood coagulation function (the 1th, 3th, 5th, 7th)(2 year)
  • Preoperative viral loading(2 year)

Study Sites (1)

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