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Trial record 19 of 146 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03132649
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Three-dimensional Visualization on Operation Strategy and Complications for Hilar Cholangiocarcinoma
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Blood routine examination (the 1th, 3 th, 5th, 7th) [ Time Frame: 2 year ]
    Hemoglobin(g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%)

  2. 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)

  3. Stool Routine (the 1th, 3 th,5th, 7th) [ Time Frame: 2 year ]
    Defecate occult blood test, Microorganisms (mold, parasites, etc.)

  4. 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)

  5. 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)

  6. 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)

  7. Inflammatory biomarkers [ Time Frame: 2 year ]
    C-reactive protein, procalcitonin

  8. Preoperative viral loading [ Time Frame: 2 year ]
    HBV(hepatitis B virus)- DNA、HCV(hepatitis C virus)- RNA

  9. 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

  10. 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)


Biospecimen Retention:   Samples Without DNA
The biospecimen will be comformed by histopathological examination


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients with hilar cholangiocarcinoma
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132649


Locations
China, Guangdong
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Chihua Fang, MD    (+86)2062782568    s_mountain@126.com   
Contact: Qingshan Chen, MM    (+86)2062782568    s_mountain@126.com   
Sponsors and Collaborators
Zhujiang Hospital

Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03132649     History of Changes
Other Study ID Numbers: 201701
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhujiang Hospital:
Three dimensional visualization
Operation strategy

Additional relevant MeSH terms:
Cholangiocarcinoma
Klatskin Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms