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| ID | Type | Description | Link |
|---|---|---|---|
| 0054/DIA/2018/47 | Other Grant/Funding Number | Polish Ministry of Science and Higher Education |
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To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.
Project goal is to evaluate utility of personalized 3D printed models in preoperative planning and performing laparoscopic liver resections. Models will be developed with unique, low-cost approach. Project will consist of three overlapping modules/stages evaluating:
Methodology of developing 3D models is described elsewhere. Printed models will be delivered to surgical team at least 5 days prior to the resection. Surgery will be performed in both arms according to the department's procedures and surgical oncology guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With 3D Model | Experimental | Patients in this arm will undergo laparoscopic liver resection with prior planning utilizing both 3D printed model and computed tomography (or/and magnetic resonance imaging) |
|
| Without 3D Model | Active Comparator | Patients in this arm will undergo laparoscopic liver resection with prior planning utilizing only standard medical imaging computed tomography (or/and magnetic resonance imaging) without development of 3D printed model |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic liver resection | Procedure | Laparoscopic liver resection for oncological purposes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of changes in surgery plan | intraoperative | |
| Blood loss | intraoperative | |
| Operative time | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Number of both total and severe (Clavien-Dindo>=3) complications | intraoperative and until discharge, an average of 7 days |
| Length of stay | until patient discharge, an average of 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of General Surgery Jagiellonian Univeristy Medical College | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28144830 | Background | Witowski JS, Pedziwiatr M, Major P, Budzynski A. Cost-effective, personalized, 3D-printed liver model for preoperative planning before laparoscopic liver hemihepatectomy for colorectal cancer metastases. Int J Comput Assist Radiol Surg. 2017 Dec;12(12):2047-2054. doi: 10.1007/s11548-017-1527-3. Epub 2017 Jan 31. | |
| 30788245 | Result |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| 3D printing model | Device | Use of 3D printed liver model in decision-making: preoperative planning and intraoperative guidance. |
|
| Conversion rate | intraoperative |
| Readmissions | 6 months |
| Mortality | 90 days |
| Witowski J, Wake N, Grochowska A, Sun Z, Budzynski A, Major P, Popiela TJ, Pedziwiatr M. Investigating accuracy of 3D printed liver models with computed tomography. Quant Imaging Med Surg. 2019 Jan;9(1):43-52. doi: 10.21037/qims.2018.09.16. |
| 31773294 | Result | Witowski J, Budzynski A, Grochowska A, Ballard DH, Major P, Rubinkiewicz M, Zlahoda-Huzior A, Popiela TJ, Wierdak M, Pedziwiatr M. Decision-making based on 3D printed models in laparoscopic liver resections with intraoperative ultrasound: a prospective observational study. Eur Radiol. 2020 Mar;30(3):1306-1312. doi: 10.1007/s00330-019-06511-2. Epub 2019 Nov 26. |
| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |