Impact of Three-dimensional Visualization on Operation Strategy and Complications for Complex Hepatic Carcinoma
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2017
CompletedFirst Submitted
Initial submission to the registry
April 5, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedApril 19, 2018
March 1, 2018
2.2 years
April 5, 2017
April 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (9)
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
Blood biochemistry (the 1th, 3 th,5th, 7th)
2 year
Tumor marker
2 year
- +4 more secondary outcomes
Eligibility Criteria
The patients with complex hepatic carcinoma
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhujiang Hospital of The Southern Medical University
Guangzhou, Guangdong, 510282, China
Biospecimen
The biospecimen will be comformed by histopathological examination
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2017
First Posted
April 28, 2017
Study Start
March 15, 2017
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
April 19, 2018
Record last verified: 2018-03