Value of 3D Printing for Comprehension of Liver Surgical Anatomy

NCT ID: NCT03153332

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-01-10

Brief Summary

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To our knowledge, it has not been analyze whether 3D printed liver model would improve the perception of a given liver tumor or the precision of operation planning in liver surgery. We design this prospective controlled trial to test whether the 3D-printed patient specific liver model could be more informative than standard MDCT (multi-row detector computed tomography ) and 3D visualization system in predicting the surgical anatomy of liver.

Detailed Description

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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.

Conditions

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Liver Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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' comprehension of the hepatic anatomy

Intervention Type OTHER

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' comprehension of the hepatic anatomy

Intervention Type OTHER

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' comprehension of the hepatic anatomy

Intervention Type OTHER

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.

Interventions

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surgical residents' comprehension of the hepatic anatomy

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Fifth People's Hospital of Dongguan City

UNKNOWN

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tianyou Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tianyou Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center, Guangzhou Medical University

Locations

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he Fifth People's Hospital of Dongguan City

Dongguan, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 9833800 (View on PubMed)

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.

Reference Type RESULT
PMID: 11074877 (View on PubMed)

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.

Reference Type RESULT
PMID: 23959637 (View on PubMed)

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.

Reference Type RESULT
PMID: 25145821 (View on PubMed)

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.

Reference Type RESULT
PMID: 25891694 (View on PubMed)

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.

Reference Type RESULT
PMID: 28281114 (View on PubMed)

Other Identifiers

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3D printing

Identifier Type: -

Identifier Source: org_study_id

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