Individualised Liverresection Planning using 3D printing and Virtual Reality
Organizational Data
- DRKS-ID:
- DRKS00027865
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-01-24
- Last update in DRKS:
- 2023-02-21
- Registration type:
- Prospective
Acronym/abbreviation of the study
i-LiVR
URL of the study
No Entry
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.
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.
Health condition or problem studied
- ICD10:
- C78.7 - Secondary malignant neoplasm of liver and intrahepatic bile duct
- ICD10:
- C22.0 - Liver cell carcinoma
- ICD10:
- C22.1 - Intrahepatic bile duct carcinoma
- ICD10:
- D13.4 - Liver
- ICD10:
- K76.8 - Other specified diseases of liver
- ICD10:
- B67.0 - Echinococcus granulosus infection of liver
- ICD10:
- B67.5 - Echinococcus multilocularis infection of liver
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 3D PDF: The CT scan is converted into a 3D data set and viewed on a regular computer screen.
- Arm 2:
- 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.
- Arm 3:
- 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.
- Arm 4:
- Control: a CT scan is viewed on a regular computer screen and is used for preparation for the operation.
Endpoints
- 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).
- Secondary outcome:
- usability scores, duration of operation, intraoperative blood loss, postoperative hospital stay, postoperativ complications, 30 day mortality, 90 day mortality, sufficient resection margin
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie der Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Recruitment period and number of participants
- Planned study start date:
- 2022-02-01
- Actual study start date:
- 2022-05-31
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- 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
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
Addresses
Primary Sponsor
- Address:
- Universiätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie (Ansprechpartner: PD Dr. med. Huber)Langenbeckstraße 155131 MainzGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Allgemein-, Viszeral und TransplantationschirurgiePD Dr. med. Tobias HuberLangenbeckstraße 155131 MainzGermany
- Telephone:
- 0049 6131 17 2063
- Fax:
- 0049 6131 17 5554
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.unimedizin-mainz.de/avtc
Contact for Public Queries
- Address:
- Klinik für Allgemein-, Viszeral und TransplantationschirurgieYasmin Isenbruck-WenkLangenbeckstraße 155131 MainzGermany
- Telephone:
- 0049 6131 17 2846
- Fax:
- 0049 6131 17 6466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinik für Allgemein-, Viszeral und TransplantationschirurgiePD Dr. med. Tobias HuberLangenbeckstraße 155131 MainzGermany
- Telephone:
- 0049 6131 17 2063
- Fax:
- 0049 6131 17 5554
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.unimedizin-mainz.de/avtc
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsmedizin der Johannes Gutenberg-Universität MainzLangenbeckstraße 155131 MainzGermany
- Telephone:
- 0049 6131 17 2063
- Fax:
- 0049 6131 17 5554
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer Rheinland-PfalzDeutschhausplatz 355116 MainzGermany
- Telephone:
- +49-6131-288220
- Fax:
- +49-6131-2882266
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-08-01
- Ethics committee number:
- 2021-16021-andere Forschung erstvotierend
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-10-13
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- Not planned up til now.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry