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Completed

NCT Number: NCT03153332

Value of 3D Printing for Comprehension of Liver Surgical Anatomy

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

he Fifth People's Hospital of Dongguan City

Dongguan, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Time spent to judge tumor location

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Collaborators

  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • The Fifth People's Hospital of Dongguan City

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 15, 2017
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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