Value of 3D Printing for Comprehension of Liver Surgical Anatomy

Liver Cancer Clinical Trial

Official title:

Value of 3D Printing for Comprehension of Liver Surgical Anatomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153332
• Other study ID #: 3D printing
• Status: Completed
• Phase: N/A
• First received: May 6, 2017
• Last updated: January 13, 2018
• Start date: July 1, 2017
• Est. completion date: January 10, 2018

Study information

• Verified date: January 2018
• Source: Guangzhou Women and Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	he Fifth People's Hospital of Dongguan City	Dongguan	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center	Guangdong Provincial Hospital of Traditional Chinese Medicine, The Fifth People’s Hospital of Dongguan City

Country where clinical trial is conducted

China, 

References & Publications (6)

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 Su — View Citation

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 — View Citation

Lamadé W, Glombitza G, Fischer L, Chiu P, Cárdenas 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. — View Citation

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. — View Citation

Marescaux J, Clément 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. — View Citation

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.23 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Resection proposal of liver pathology	he resection proposals on the liver were compared with surgical results that had been evaluated by surgeons and judged by the formula mentioned earlier.	The secondary outcome was assessed within 1 week after the collection of each participants' response.
Secondary	Time spent to judge tumor location	The time spend to assess tumor location by each resident was documented as seconds	The secondary outcome was assessed within 1 week after the collection of each participants' response.