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Hilar CholangiocarcinomaNCT03132649

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

An observational study of Hilar Cholangiocarcinoma, run by Zhujiang Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hilar Cholangiocarcinoma
How many people
300 participants
Where
1 siteChina
Study dates
15 Mar 2017to 1 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The patients with hilar cholangiocarcinoma

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510282

    Chihua Fang, MD, (+86)2062782568, s_mountain@126.com

    Qingshan Chen, MM, (+86)2062782568, s_mountain@126.com

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Keywords
Three dimensional visualization, Operation strategy
Medical subject headings
Klatskin Tumor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact on operation strategy of three-dimensional visualization technique

    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.

    Measured: 2 year

  2. Impact on complications of three-dimensional visualization technique

    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.

    Measured: 2 year

Secondary outcomes (10)

  1. Blood routine examination (the 1th, 3 th, 5th, 7th)

    Hemoglobin(g/L), Platelet(109/L), and neutrophilic granulocyte percentage (%)

    Measured: 2 year

  2. Urine routines (the 1th, 3 th,5th, 7th)

    Urine specific gravity, urine protein(mg/dl), urine sugar(mmol/L), leukocytes in urine(number/ul), urine erythrocyte(number/ul)

    Measured: 2 year

  3. Stool Routine (the 1th, 3 th,5th, 7th)

    Defecate occult blood test, Microorganisms (mold, parasites, etc.)

    Measured: 2 year

  4. Blood biochemistry (the 1th, 3 th,5th, 7th)

    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)

    Measured: 2 year

  5. Tumor marker

    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)

    Measured: 2 year

  6. The blood coagulation function (the 1th, 3th, 5th, 7th)

    prothrombin time (PT, s), partial thromboplastin time (APTT), international normalized ratio (INR), plasma prothrombin activity (PTA, %), fibrinogen (FIB, g/L), d-dimer(mg/L)

    Measured: 2 year

  7. Inflammatory biomarkers

    C-reactive protein, procalcitonin

    Measured: 2 year

  8. Preoperative viral loading

    HBV(hepatitis B virus)- DNA、HCV(hepatitis C virus)- RNA

    Measured: 2 year

  9. Postoperative results of paraffin wax and immunohistochemical index

    CK7、CK18、CK19、Hepatocyte、CD34（vascular）、S-100（nerve）、D2-40（lymphatic）、AFP、Ki67

    Measured: 2 year

  10. Postoperative pathologic examination

    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)

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2017
  2. Study start15 Mar 2017
  3. Primary completion1 Jun 2019 (estimated)
  4. Study completion1 Jun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03132649
Sponsor's protocol ID
201701
Status last verified
Feb 2018
First submitted
9 Apr 2017
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hilar Cholangiocarcinoma, run by Zhujiang Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact on operation strategy of three-dimensional visualization technique (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03132649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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