Liver DiseasesNCT03074708
Application of 3D Visualization and 3D Printing in the Hepatobiliary and Pancreatic Surgery
A study testing 3D visualization and 3D printing in people with Liver Diseases and Pancreatic Diseases, run by Zhujiang Hospital at 1 site in China.
Trial summary
Background:The aim of the study is to value the application of three-dimensional visualization and three-dimensional printing in the hepatobiliary and pancreatic surgery.Method：From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Diseases, Pancreatic Diseases, Biliary Tract Diseases
- What is being tested?
- 3D visualization and 3D printing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2017to Dec 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- the hepatobiliary and pancreatic diseases
Who cannot join
- none of the hepatobiliary and pancreatic diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of The Southern Medical University
Guangzhou, Guangdong, 510282
Chihua Fang, MD, (+86)2062782568, zjyyfch@sina.com
Nan Xiang, MD, (+86)2062782568, zjyyxn@126.com
About this study
Official title: Zhujiang Hospital of the Southern Medical University
Background:The aim of the study is to value the application of three-dimensional visualization and three-dimensional printing in the hepatobiliary and pancreatic surgery.Method：From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.
Read the detailed description
From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.
- Conditions
- Liver Diseases, Pancreatic Diseases, Biliary Tract Diseases
- Being tested
- 3D visualization and 3D printing
- Keywords
- Three-Dimensional Image, Three Dimensional Printing
- Medical subject headings
- Liver Diseases, Pancreatic Diseases, Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D visualization and 3D printingOther
From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 3D visualization and 3D printing | Other | From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery. Receives: Other: 3D visualization and 3D printing |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
operative time
Measured: 1 year
Secondary outcomes (2)
intraoperative blood loss
intraoperative blood loss
Measured: 1 year
postoperative complications after surgery
postoperative complications after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chihua Fang, Zhujiang Hospital
- Investigators
- Chihua Fang, MD, Study chair, Zhujiang Hospital of The Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074708
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2017
- First submitted
- 29 Jan 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zhujiang Hospital of the Southern Medical University
- ClinicalTrials.gov ID
- NCT03074708
- Acronym / sponsor ID
- 001
- Conditions
- Liver Diseases, Pancreatic Diseases, Biliary Tract Diseases
- Keywords
- Three-Dimensional Image, Three Dimensional Printing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:The aim of the study is to value the application of three-dimensional visualization and three-dimensional printing in the hepatobiliary and pancreatic surgery.Method：From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.
Detailed description
From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D visualization and 3D printing | Other | Other: 3D visualization and 3D printingFrom January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the hepatobiliary and pancreatic diseases
Key exclusion criteria (1 listed)
- none of the hepatobiliary and pancreatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D visualization and 3D printingFrom January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery. | Other | 3D visualization and 3D printing |
Primary outcome
operative time
Time frame: 1 year
operative time
2 secondary outcomes
intraoperative blood loss
Time frame: 1 year
postoperative complications after surgery
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chihua Fang, MD study chair
Zhujiang Hospital of The Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D visualization and 3D printing in people with Liver Diseases and Pancreatic Diseases, 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 1 inclusion and 1 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 9 Mar 2017. 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?
Contact Chihua Fang, MD ((+86)2062782568, zjyyfch@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2017.