Impact of Three-dimensional Visualization on Operation Strategy and Complications for Hilar Cholangiocarcinoma
- Conditions
- Hilar Cholangiocarcinoma
- Registration Number
- NCT03132649
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Impact on complications 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 complications (number) will be recorded.
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.
- Secondary Outcome Measures
Name Time Method Stool Routine (the 1th, 3 th,5th, 7th) 2 year Defecate occult blood test, Microorganisms (mold, parasites, etc.)
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)
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)
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)
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)
Preoperative viral loading 2 year HBV(hepatitis B virus)- DNA、HCV(hepatitis C virus)- RNA
Blood routine examination (the 1th, 3 th, 5th, 7th) 2 year Hemoglobin(g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%)
Inflammatory biomarkers 2 year C-reactive protein, procalcitonin
Postoperative results of paraffin wax and immunohistochemical index 2 year CK7、CK18、CK19、Hepatocyte、CD34（vascular）、S-100（nerve）、D2-40（lymphatic）、AFP、Ki67
Postoperative pathologic examination 2 year The stage of TNM, The condition of resection (R0/R1/R2), the condition of liver cirrhosis, the pathological type of the tumor (Nipple type/nodule type/infiltration type)
Trial Locations
- Locations (1)
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China