- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153332
Value of 3D Printing for Comprehension of Liver Surgical Anatomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective was to investigate whether 3D printing can improve localization of hepatic pathology. The secondary objective was to investigate whether 3D printing can improve the precision of surgical proposal.
The dataset of patients were prepared and stratified into MDCT, 3D visualization system and 3D printed liver model groups. The process started from MDCT scan image acquisition and moved through image segmentation and 3D rendering to end up with 3D printing.
Surgical residents were assigned to three different groups to study different modes of patients' data. Residents were ask to state the liver segment in which the tumor resides and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue. Residents were recommended to proceed in a classic way by resecting the whole liver segment. The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Guangdong
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Dongguan, Guangdong, China
- he Fifth People's Hospital of Dongguan City
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Surgical residents
- Must had experiences with MDCT and 3D visualization system
Exclusion Criteria:
- Non surgical residents
- No experiences with MDCT or 3D visualization system
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
MDCT group
The MDCT images of seven hepatic tumors were loaded on software to uniform study conditions, allowing both axial and coronal scans visualization.
|
Surgical residents were assigned to three different groups to evaluate different modes of patients' data.
Residents were ask to state the liver segment in which the tumor resided and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue.
Residents were recommended to proceed in a classic way by resecting the whole liver segment.
The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.
|
3D visualization system group
The 3D virtual reconstructions of seven hepatic tumors were loaded on the visualization software which enables the rotation of the virtual model.
|
Surgical residents were assigned to three different groups to evaluate different modes of patients' data.
Residents were ask to state the liver segment in which the tumor resided and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue.
Residents were recommended to proceed in a classic way by resecting the whole liver segment.
The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.
|
3D printing group
3D-printed models of seven hepatic tumors were created based on MDCT images, participants were allowed to freely handle them.
|
Surgical residents were assigned to three different groups to evaluate different modes of patients' data.
Residents were ask to state the liver segment in which the tumor resided and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue.
Residents were recommended to proceed in a classic way by resecting the whole liver segment.
The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcomes was the precise allocation of hepatic disease
Time Frame: The primary outcome was assessed within 1 week after the collection of each participants' response.
|
For tumor allocation to the liver segments, 8 points were awarded if all segments were correctly identified in which the tumors resided.
If the tumors was located in more than one segment, the 8 maximal achievable points were divided between these segments.
Erroneously identified segments were awarded 0 point.
Alternatively, the primary outcomes were also simply judged as right or wrong according to the final surgical results.
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The primary outcome was assessed within 1 week after the collection of each participants' response.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resection proposal of liver pathology
Time Frame: The secondary outcome was assessed within 1 week after the collection of each participants' response.
|
he resection proposals on the liver were compared with surgical results that had been evaluated by surgeons and judged by the formula mentioned earlier.
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The secondary outcome was assessed within 1 week after the collection of each participants' response.
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Time spent to judge tumor location
Time Frame: The secondary outcome was assessed within 1 week after the collection of each participants' response.
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The time spend to assess tumor location by each resident was documented as seconds
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The secondary outcome was assessed within 1 week after the collection of each participants' response.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tianyou Yang, MD, Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Publications and helpful links
General Publications
- Marescaux J, Clement JM, Tassetti V, Koehl C, Cotin S, Russier Y, Mutter D, Delingette H, Ayache N. Virtual reality applied to hepatic surgery simulation: the next revolution. Ann Surg. 1998 Nov;228(5):627-34. doi: 10.1097/00000658-199811000-00001.
- Lamade W, Glombitza G, Fischer L, Chiu P, Cardenas CE Sr, Thorn M, Meinzer HP, Grenacher L, Bauer H, Lehnert T, Herfarth C. The impact of 3-dimensional reconstructions on operation planning in liver surgery. Arch Surg. 2000 Nov;135(11):1256-61. doi: 10.1001/archsurg.135.11.1256.
- Zein NN, Hanouneh IA, Bishop PD, Samaan M, Eghtesad B, Quintini C, Miller C, Yerian L, Klatte R. Three-dimensional print of a liver for preoperative planning in living donor liver transplantation. Liver Transpl. 2013 Dec;19(12):1304-10. doi: 10.1002/lt.23729. Epub 2013 Oct 21.
- Igami T, Nakamura Y, Hirose T, Ebata T, Yokoyama Y, Sugawara G, Mizuno T, Mori K, Nagino M. Application of a three-dimensional print of a liver in hepatectomy for small tumors invisible by intraoperative ultrasonography: preliminary experience. World J Surg. 2014 Dec;38(12):3163-6. doi: 10.1007/s00268-014-2740-7.
- Kusaka M, Sugimoto M, Fukami N, Sasaki H, Takenaka M, Anraku T, Ito T, Kenmochi T, Shiroki R, Hoshinaga K. Initial experience with a tailor-made simulation and navigation program using a 3-D printer model of kidney transplantation surgery. Transplant Proc. 2015 Apr;47(3):596-9. doi: 10.1016/j.transproceed.2014.12.045.
- Marconi S, Pugliese L, Botti M, Peri A, Cavazzi E, Latteri S, Auricchio F, Pietrabissa A. Value of 3D printing for the comprehension of surgical anatomy. Surg Endosc. 2017 Oct;31(10):4102-4110. doi: 10.1007/s00464-017-5457-5. Epub 2017 Mar 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3D printing
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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