- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03749005
Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer
November 19, 2018 updated by: Zhujiang Hospital
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 Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chihua Fang, M.D.;Ph.D
- Phone Number: (+86)2062782568
- Email: s_mountain@126.com
Study Locations
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-
Guangdong
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Guangzhou, Guangdong, China, 510282
- Recruiting
- Zhujiang Hospital of The Southern Medical University
-
Contact:
- Chihua Fang, MD
- Phone Number: (+86)2062782568
- Email: s_mountain@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients with Pancreatic Cancer.
Description
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:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact on operation strategy of three dimensional visualization technique
Time Frame: 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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact on complication of three dimensional visualization technique
Time Frame: 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.
|
30 days
|
1-year disease free survival rate
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2017
Primary Completion (Anticipated)
April 30, 2020
Study Completion (Anticipated)
August 30, 2020
Study Registration Dates
First Submitted
November 19, 2018
First Submitted That Met QC Criteria
November 19, 2018
First Posted (Actual)
November 21, 2018
Study Record Updates
Last Update Posted (Actual)
November 21, 2018
Last Update Submitted That Met QC Criteria
November 19, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201801
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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