Clinical Trial: Impact of Three-dimensional Visualization on Operation Strategy and Complications for Hilar Cholangiocarcinoma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Impact of Three-dimensional Visualization on Operation Strategy and Complications for 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 Summary: 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.
Sponsor: Zhujiang Hospital

Current Primary Outcome:

  • 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 complications 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 complications (number) will be recorded.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood routine examination (the 1th, 3 th, 5th, 7th) [ Time Frame: 2 year ]
    Hemoglobin(g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%)
  • Urine routines (the 1th, 3 th,5th, 7th) [ Time Frame: 2 year ]
    Urine specific gravity, urine protein(mg/dl), urine sugar(mmol/L), leukocytes in urine(number/ul), urine erythrocyte(number/ul)
  • Stool Routine (the 1th, 3 th,5th, 7th) [ Time Frame: 2 year ]
    Defecate occult blood test, Microorganisms (mold, parasites, etc.)
  • Blood biochemistry (the 1th, 3 th,5th, 7th) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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)
  • Inflammatory biomarkers [ Time Frame: 2 year ]
    C-reactive protein, procalcitonin
  • Preoperative viral loading [ Time Frame: 2 year ]
    HBV(hepatitis B virus)- DNA、HCV(hepatitis C virus)- RNA
  • Postoperative results of paraffin wax and immunohistochemical index [ Time Frame: 2 year ]
    CK7、CK18、CK19、Hepatocyte、CD34（vascular）、S-100（nerve）、D2-40（lymphatic）、AFP、Ki67
  • Postoperative pathologic examination [ Time Frame: 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)


Original Secondary Outcome: Same as current

Information By: Zhujiang Hospital

Dates:
Date Received: April 9, 2017
Date Started: May 15, 2017
Date Completion: May 1, 2019
Last Updated: May 15, 2017
Last Verified: February 2017