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Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Primary Purpose

Liver Cancer, Hepatocellular Carcinoma, Liver Metastases

Status

Active

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Laparoscopic liver resection

3D printing model

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring 3D printing, Liver cancer, Laparoscopic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

2nd Department of General Surgery Jagiellonian Univeristy Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With 3D Model

Without 3D Model

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Number of changes in surgery plan

Blood loss

Operative time

Secondary Outcome Measures

Complications

Number of both total and severe (Clavien-Dindo>=3) complications

Length of stay

Conversion rate

Readmissions

Mortality

Full Information

NCT ID

NCT03744624

First Posted

November 13, 2018

Last Updated

August 12, 2022

Sponsor

Jagiellonian University

1. Study Identification

Unique Protocol Identification Number

NCT03744624

Brief Title

Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Official Title

Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 28, 2017 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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: Accuracy of 3D printed liver models compared to computed tomography and standard surface or volume rendering Whether 3D printed utilized in planning surgery affects the decision making regarding the surgical plan 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer, Hepatocellular Carcinoma, Liver Metastases

Keywords

3D printing, Liver cancer, Laparoscopic surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

With 3D Model

Arm Type

Experimental

Arm Description

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)

Arm Title

Without 3D Model

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic liver resection

Intervention Description

Laparoscopic liver resection for oncological purposes

Intervention Type

Device

Intervention Name(s)

3D printing model

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of changes in surgery plan

Time Frame

intraoperative

Title

Blood loss

Time Frame

intraoperative

Title

Operative time

Time Frame

intraoperative

Secondary Outcome Measure Information:

Title

Complications

Description

Number of both total and severe (Clavien-Dindo>=3) complications

Time Frame

intraoperative and until discharge, an average of 7 days

Title

Length of stay

Time Frame

until patient discharge, an average of 7 days

Title

Conversion rate

Time Frame

intraoperative

Title

Readmissions

Time Frame

6 months

Title

Mortality

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

2nd Department of General Surgery Jagiellonian Univeristy Medical College

City

Kraków

State/Province

Małopolskie

ZIP/Postal Code

31-501

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28144830

Citation

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.

Results Reference

background

PubMed Identifier

30788245

Citation

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.

Results Reference

result

PubMed Identifier

31773294

Citation

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.

Results Reference

result

Learn more about this trial

Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

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