Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-28

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas

NCT03382327

Hepatocarcinoma

COMPLETED NA

Feasibility Analysis of LCD-SLA 3D Printing Technology for Overall Surgical Planning of Liver Malignant Tumors

NCT06526754

Hepatobiliary Surgery Liver Diseases

COMPLETED NA

National Polish Registry of Minimally Invasive Liver Surgery

NCT05516394

Liver Tumor

RECRUITING

Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver

NCT01474694

Adult Liver Cancer

COMPLETED

Robotic Versus Laparoscopic Liver Resection for Hepatocellular Carcinoma

NCT06496113

Hepatocellular Carcinoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cancer Hepatocellular Carcinoma Liver Metastases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Laparoscopic liver resection

Intervention Type PROCEDURE

Laparoscopic liver resection for oncological purposes

3D printing model

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Laparoscopic liver resection

Intervention Type PROCEDURE

Laparoscopic liver resection for oncological purposes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic liver resection

Laparoscopic liver resection for oncological purposes

Intervention Type PROCEDURE

3D printing model

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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