Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

August 12, 2022 updated by: Jan Witowski, Jagiellonian University
To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Accuracy of 3D printed liver models compared to computed tomography and standard surface or volume rendering
  2. Whether 3D printed utilized in planning surgery affects the decision making regarding the surgical plan
  3. Whether 3D printed models utilized in planning and navigating laparoscopic resections affect perioperative outcomes

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.

Study Type

Interventional

Enrollment (Anticipated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Małopolskie
      • Kraków, Małopolskie, Poland, 31-501
        • 2nd Department of General Surgery Jagiellonian Univeristy Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With 3D Model
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 resection
Laparoscopic liver resection for oncological purposes
Device: 3D printing model
Use of 3D printed liver model in decision-making: preoperative planning and intraoperative guidance.
Active Comparator: Without 3D Model
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
Laparoscopic liver resection for oncological purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of changes in surgery plan
Time Frame: intraoperative
intraoperative
Blood loss
Time Frame: intraoperative
intraoperative
Operative time
Time Frame: intraoperative
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
90 days
Complications
Time Frame: intraoperative and until discharge, an average of 7 days
Number of both total and severe (Clavien-Dindo>=3) complications
intraoperative and until discharge, an average of 7 days
Length of stay
Time Frame: until patient discharge, an average of 7 days
until patient discharge, an average of 7 days
Conversion rate
Time Frame: intraoperative
intraoperative
Readmissions
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2017

Primary Completion (Actual)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 122.6120.81.2017
  • 0054/DIA/2018/47 (Other Grant/Funding Number: Polish Ministry of Science and Higher Education)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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