Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer

Sponsor
Zhujiang Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03749005
Collaborator
(none)
100
1
40.4
2.5

Study Details

Study Description

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 Pancreatic Cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Because of the complexity of Pancreatic Cancer, 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 Pancreatic Cancer.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer
    Actual Study Start Date :
    Apr 18, 2017
    Anticipated Primary Completion Date :
    Apr 30, 2020
    Anticipated Study Completion Date :
    Aug 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Impact on operation strategy of three dimensional visualization technique [30 days]

      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

    1. Impact on complication of three dimensional visualization technique [30 days]

      The early postoperative complication and mortality are defined as the event observed within 30 days after surgerypostoperative bleeding, biliary fistula, ascites, postoperative liver failure, renal dysfunction, pleural effusion, abdominal cavity infection, abdominal abscess, incision infection, the occurrence cases of each complication (number) will be recorded.

    2. 1-year disease free survival rate [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1.18 years≤ Age ≤70 years 2.Compling with the diagnosis criteria of Pancreatic Cancer. 3.Primary Pancreatic Cancer without metastasis. 4.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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhujiang Hospital of The Southern Medical University Guangzhou Guangdong China 510282

    Sponsors and Collaborators

    • Zhujiang Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhujiang Hospital
    ClinicalTrials.gov Identifier:
    NCT03749005
    Other Study ID Numbers:
    • 201801
    First Posted:
    Nov 21, 2018
    Last Update Posted:
    Nov 21, 2018
    Last Verified:
    Apr 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhujiang Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 21, 2018