NCT03744624

Brief Summary

To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

5.1 years

First QC Date

November 13, 2018

Last Update Submit

August 12, 2022

Conditions

Liver CancerHepatocellular CarcinomaLiver Metastases

Keywords

3D printingLiver cancerLaparoscopic surgery

Outcome Measures

Primary Outcomes (3)

  • Number of changes in surgery plan

    intraoperative

  • Blood loss

    intraoperative

  • Operative time

    intraoperative

Secondary Outcomes (5)

  • Complications

    intraoperative and until discharge, an average of 7 days

  • Length of stay

    until patient discharge, an average of 7 days

  • Conversion rate

    intraoperative

  • Readmissions

    6 months

  • Mortality

    90 days

Study Arms (2)

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)

Procedure: Laparoscopic liver resectionDevice: 3D printing model

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

Procedure: Laparoscopic liver resection

Interventions

Laparoscopic liver resectionPROCEDURE

Laparoscopic liver resection for oncological purposes

With 3D ModelWithout 3D Model
3D printing modelDEVICE

Use of 3D printed liver model in decision-making: preoperative planning and intraoperative guidance.

With 3D Model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18
  • Patient qualified to undergo liver tumor resection (either primary of metastatic; both benign and malignant lesions)
  • Quality of imaging (CT or MRI or PET (positron emission tomography)/CT) satisfactory to develop 3D models
  • Laparoscopic approach
  • Informed consent

You may not qualify if:

  • Open approach
  • Technical limitations to model development
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Department of General Surgery Jagiellonian Univeristy Medical College

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Related Publications (3)

  • 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.

    PMID: 28144830BACKGROUND

  • 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.

    PMID: 30788245RESULT

  • 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.

    PMID: 31773294RESULT

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 16, 2018

Study Start

April 28, 2017

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Locations

PL(1)