Clinical trial NCT03132649: Impact of Three-dimensional Visualization on Operation Strategy and Complications for Hilar Cholangiocarcinoma
Official title: Impact of Three-dimensional Visualization on Operation Strategy and Complications for Hilar Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hilar Cholangiocarcinoma
Keywords: Three dimensional visualization
Operation strategy
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with hilar cholangiocarcinoma

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 hilar cholangiocarcinoma.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 18 years≤ Age ≤70 years
2. Complying with the diagnosis criteria of hilar cholangiocarcinoma.
3. Without intrahepatic or extrahepatic extensive cancer metastasis.
4. 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).
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.

Primary outcomes:
measure: Impact on operation strategy of three-dimensional visualization technique
timeFrame: 2 year
measure: Impact on complications of three-dimensional visualization technique
timeFrame: 2 year
Secondary outcomes:
measure: Blood routine examination (the 1th, 3 th, 5th, 7th)
timeFrame: 2 year
measure: Urine routines (the 1th, 3 th,5th, 7th)
timeFrame: 2 year
measure: Stool Routine (the 1th, 3 th,5th, 7th)
timeFrame: 2 year
measure: Blood biochemistry (the 1th, 3 th,5th, 7th)
timeFrame: 2 year
measure: Tumor marker
timeFrame: 2 year
measure: The blood coagulation function (the 1th, 3th, 5th, 7th)
timeFrame: 2 year
measure: Inflammatory biomarkers
timeFrame: 2 year
measure: Preoperative viral loading
timeFrame: 2 year
measure: Postoperative results of paraffin wax and immunohistochemical index
timeFrame: 2 year
measure: Postoperative pathologic examination
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: