Impact of Three-dimensional Visualization on Operation Strategy and Complications for Hilar Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Impact on complications of three-dimensional visualization technique
研究概览
简要总结
The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional visualization on operation strategy and complications for hilar cholangiocarcinoma.
详细描述
Because of the complexity of hilar cholangiocarcinoma,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 hilar cholangiocarcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years≤ Age ≤70 years
- •Complying with the diagnosis criteria of hilar cholangiocarcinoma.
- •Without intrahepatic or extrahepatic extensive cancer metastasis.
- •Preoperative serum bilirubin ≤51.3 umol/L or preoperative serum bilirubin < 200 umol/L after the drainage by PTCD(percutaneous transhepaticcholangial drainage)/ENBD(endoscopic nasobiliary drainage).
- •The patients are volunteered for the study.
排除标准
- •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.
结局指标
主要结局
Impact on complications of three-dimensional visualization technique
时间窗: 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 complications (number) will be recorded.
Impact on operation strategy of three-dimensional visualization technique
时间窗: 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.
次要结局
- Stool Routine (the 1th, 3 th,5th, 7th)(2 year)
- Blood biochemistry (the 1th, 3 th,5th, 7th)(2 year)
- Tumor marker(2 year)
- The blood coagulation function (the 1th, 3th, 5th, 7th)(2 year)
- Urine routines (the 1th, 3 th,5th, 7th)(2 year)
- Preoperative viral loading(2 year)
- Blood routine examination (the 1th, 3 th, 5th, 7th)(2 year)
- Inflammatory biomarkers(2 year)
- Postoperative results of paraffin wax and immunohistochemical index(2 year)
- Postoperative pathologic examination(2 year)