Trial document




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  DRKS00027865

Trial Description

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Title

Individualised Liverresection Planning using 3D printing and Virtual Reality

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Trial Acronym

i-LiVR

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URL of the Trial

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Brief Summary in Lay Language

Liver resections, no matter if for benign or malign diseases, are demanding because of the special anatomy of the liver. The liver consists of eight segments of which each has its own blood vessels and bilde ducts. All liver resections have to respect these structures. Furthermore the function of the liver can not be replaced, hence the amount resected is finite. These facts deem the planinng of liver resections as extremely important. Up until now the planning of liver resections was conducted by the surgeon using two dimensional CT scans. The surgeon has to convert these 2D images into a 3D model by the power of his imagination. Several other ways of presenting these data have been developed in the mean time, of which we would like to compare the following:
1. a 3D PDF, which is viewed on a regular computer screen
2. a 3D print, which the surgeon can pick up and view
3. a 3D model of the liver, which is viewed in virtual reality using a VR-headset
4. the goldstandard of the 2D CT scan.

The study aims to compare the planned resection volume and the actual resection volume as well as to compare the intra- and postoperative course between the groups.

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Brief Summary in Scientific Language

Liver resections are demanding because of the special anatomy of the liver and the high interindividual variability of the afore mentioned. Preoperative planning of liver resections is a key step if successful liver surgery. Up until now this planning step was performed on two dimensional CT scans, the conversion of these data into a three dimensional construct was left to the surgeons power of imagination. A skill that is hard to master and even harder to teach. Several other ways of presenting these data have been developed in the mean time, of which we aim to compare the following:
1. 3D PDF: a 3D reconstruction is viewed on a regular computer screen, the volumetry is performed on this 3d PDF.
2. 3D print: the 3D data set is exported and a 3D print is manufactured. The volumetry is performed using the 3D printed model on a 2D data set on the computer screen.
3. 3D Virtual Reality (VR): the 3D data set is exported into an existing VR application. The volumetry is performed using the VR application.
4. Control: a 2D CT scan is available for planning and volumetry.

The study aims to compare the difference between planned and actual resection volume as a primary end point. Secondary end points include intra- and postoperative course as well as usability for the surgical team.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Not planned up til now.

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Organizational Data

  •   DRKS00027865
  •   2022/01/24
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  •   yes
  •   Approved
  •   2021-16021-andere Forschung erstvotierend, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   C78.7 -  Secondary malignant neoplasm of liver and intrahepatic bile duct
  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
  •   C22.1 -  Malignant neoplasm: Intrahepatic bile duct carcinoma
  •   D13.4 -  Benign neoplasm: Liver
  •   K76.8 -  Other specified diseases of liver
  •   B67.0 -  Echinococcus granulosus infection of liver
  •   B67.5 -  Echinococcus multilocularis infection of liver
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Interventions/Observational Groups

  •   3D PDF: The CT scan is converted into a 3D data set and viewed on a regular computer screen.
  •   3d print: The CT scan is converted into a 3D data set and a 3D print is manufactured. The surgeon uses this 3D model to prepare for the operation.
  •   3D VR: the CT scan is converted into a 3D data set and exported for the use with a virtual reality (VR) headset. The surgeon uses this to preapre for the operation.
  •   Control: a CT scan is viewed on a regular computer screen and is used for preparation for the operation.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Quotient of the planned resection volume (RLV1) and the actual resected volume (RLV2), measured by water displacement volumetry, is going to be analyzed ((RLV2 – RLV1)/RLV1).

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Secondary Outcome

usability scores, duration of operation, intraoperative blood loss, postoperative hospital stay, postoperativ complications, 30 day mortality, 90 day mortality, sufficient resection margin

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2022/02/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

elective, primary liver resection laparoscopic and conventional, anatomical and atypical liver resection, major liver resection (>3 segments), age >18, availability of a contrast enhanced ct scan with 3 phases, signed informed consent

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Exclusion Criteria

minor liver reseczion, recurrent liver resection, further intraoperative steps planned ahead of time (i.e. simultaneous colon resection, multivsceral resection), cirrhosis of the liver Child B and C

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Addresses

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    • Universiätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie (Ansprechpartner: PD Dr. med. Huber)
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Klinik für Allgemein-, Viszeral und Transplantationschirurgie
    • Mr.  PD Dr. med.  Tobias  Huber 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Klinik für Allgemein-, Viszeral und Transplantationschirurgie
    • Ms.  Yasmin  Isenbruck-Wenk 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Mr.  PD Dr. med.  Tobias  Huber 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.