The Development and Study of a 3D-Printed Model for Surgical Planning of Lung Cancer with Realistic Subsegmental Boundaries and Complete Tissue Structures

September 17, 2024 updated by: Ke Zhang
This project focuses on the development of a precision multi-organ surgical planning model aided by artificial intelligence (AI), computer-aided design (CAD), multi-material 3D printing, and multimodal 3D modeling. The integration of these advanced technologies aims to enhance the accuracy and efficiency of preoperative planning for complex surgical procedures involving multiple organs. By leveraging AI and CAD, the project seeks to create detailed, patient-specific 3D models that incorporate various imaging modalities. These models will be used to guide multi-material 3D printing, producing highly accurate replicas of anatomical structures. The ultimate goal is to improve surgical outcomes by providing surgeons with precise and comprehensive tools for planning and executing intricate surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

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

  • China
    • Hebei
      • Baoding, Hebei, China, 071000
        • Affiliated Hospital of Hebei University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study includes all lung cancer patients who underwent surgery at the Affiliated Hospital of Hebei University from 2020 to 2023.

Description

Inclusion Criteria:

  • Patients diagnosed with lung cancer
  • Complete clinical case data;
  • All patients underwent surgical treatment;
  • Voluntarily participate in the study and sign the informed consent.

Exclusion Criteria:

  • Severe comorbidities, such as uncontrolled heart disease or diabetes
  • History of major surgeries or other interventions
  • Unwillingness to participate in the study

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3D reconstruction
Patients in this group underwent surgical planning with the aid of 3D reconstruction technology, which included preoperative imaging and 3D modeling to assist in the planning of thoracic surgery.
Device: 3D Reconstruction Technology
Utilization of 3D reconstruction technology to assist in preoperative planning and surgical procedures for thoracic surgery patients.
Non-3D reconstruction
Patients in this group underwent traditional surgical planning without the use of 3D reconstruction technology, relying on standard preoperative imaging and planning techniques.
Device: No 3D reconstruction is used
This group did not use 3D reconstruction for surgical navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation Time
Time Frame: During the surgery
Measure the total duration of the surgery in minutes.
During the surgery
Blood Loss
Time Frame: During the surgery
Assess the total blood loss during surgery in milliliters.
During the surgery
Postoperative Complications
Time Frame: Within 30 days post-surgery
Record any complications within 30 days post-surgery.
Within 30 days post-surgery

Collaborators and Investigators

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

Sponsor

Ke Zhang

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)

January 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19277731D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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