Value of 3D Printing for Comprehension of Liver Surgical Anatomy

NCT03153332 | Completed

• 1 other identifier: 3D printing
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• The primary outcomes was the precise allocation of hepatic disease

  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.

  The primary outcome was assessed within 1 week after the collection of each participants' response.

Secondary Outcomes (2)

• Resection proposal of liver pathology

  The secondary outcome was assessed within 1 week after the collection of each participants' response.

• Time spent to judge tumor location

  The secondary outcome was assessed within 1 week after the collection of each participants' response.

Study Arms (3)

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

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

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

Interventions

surgical residents' comprehension of the hepatic anatomy 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 visualization system group; MDCT group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Medical students had to finish five year medical school education (including one year internship), and then went into at least 3 year training program for surgical residency. Those who had finished training of general surgery were the study population.

You may qualify if:

• Surgical residents
• Must had experiences with MDCT and 3D visualization system

You may not qualify if:

• Non surgical residents
• No experiences with MDCT or 3D visualization system

Sponsors & Collaborators

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

Study Sites (1)

he Fifth People's Hospital of Dongguan City

Dongguan, Guangdong, China

Location

Related Publications (6)

• 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.

  PMID: 9833800 RESULT

• 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.

  PMID: 11074877 RESULT

• 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.

  PMID: 23959637 RESULT

• 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.

  PMID: 25145821 RESULT

• 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.

  PMID: 25891694 RESULT

• 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.

  PMID: 28281114 RESULT

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Tianyou Yang, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2017
• First Posted: May 15, 2017
• Study Start: July 1, 2017
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

CN (1)