Value of 3D Printing for Comprehension of Liver Surgical Anatomy

Sponsor
Guangzhou Women and Children's Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03153332
Collaborator
The Fifth People's Hospital of Dongguan City (Other), Guangdong Provincial Hospital of Traditional Chinese Medicine (Other)
59
1
6.3
9.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: surgical residents' comprehension of the hepatic anatomy

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 Design

Study Type:
Observational
Actual Enrollment :
59 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Value of 3D Printing for Comprehension of Liver Surgical Anatomy
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Jan 10, 2018
Actual Study Completion Date :
Jan 10, 2018

Arms and Interventions

Arm 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.

Other: 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.

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.

Other: 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.

3D printing group

3D-printed models of seven hepatic tumors were created based on MDCT images, participants were allowed to freely handle them.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. The primary outcomes was the precise allocation of hepatic disease [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.

Secondary Outcome Measures

  1. Resection proposal of liver pathology [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.

  2. Time spent to judge tumor location [The secondary outcome was assessed within 1 week after the collection of each participants' response.]

    The time spend to assess tumor location by each resident was documented as seconds

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 he Fifth People's Hospital of Dongguan City Dongguan Guangdong China

Sponsors and Collaborators

  • Guangzhou Women and Children's Medical Center
  • The Fifth People's Hospital of Dongguan City
  • Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Tianyou Yang, MD, Guangzhou Women and Children's Medical Center, Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tianyou Yang, Principal Investigator, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier:
NCT03153332
Other Study ID Numbers:
  • 3D printing
First Posted:
May 15, 2017
Last Update Posted:
Jan 17, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2018