Back to results3D Printed Models for Liver Surgery
Primary Purpose
Liver Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
3D Printed Model for preoperative planning
Sponsored by
About this trial
This is an interventional device feasibility trial for Liver Cancer
Eligibility Criteria
Inclusion Criteria: 18-80 years old; Patients with a resectable tumor in the liver; Eastern Cooperative Oncology Group Performance status score: 0; Child-Pugh classification: A; The Laboratory test results meet the following criteria and patients can tolerate surgery: Haemoglobin≥90g/L, Neutrophil count≥1.5×10⁹/L, Platelet count≥100×10⁹/L, Aspartate or alanine aminotransferase≤5 upper limits of normal(ULN）, alkaline phosphatase≤2.5 ULN, Serum albumin≥30g/L, serum creatinine<1.5 ULN, International normalized ratios（INR）≤2 or Prothrombin time（PT）exceed ULN≤6s, Creatinine clearance≥60 mL/min. Exclusion Criteria: Patients with extra-hepatic metastasis; Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation in 28 days prior to the surgery; Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy; Severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease), uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L); There are other unsuitable candidates for clinical trials, such as mental illness or alcohol dependence.
Sites / Locations
- 1# Banshan East Rd. Zhejiang cancer hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm Description
Outcomes
Primary Outcome Measures
R0 resection rate
The proportion of patients who achieved pathological negative surgical margin
Secondary Outcome Measures
Injury of vital vascular structures
The Injury of vital vascular structures, such as portal veins or hepatic veins.
Operation time
Time length (minute) between the beginning and the end of the surgery.
Blood loss
The amount of lost blood (ml) in the operation.
Full Information
NCT ID
NCT06006338
First Posted
August 16, 2023
Last Updated
September 18, 2023
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06006338
Brief Title
3D Printed Models for Liver Surgery
Official Title
The Clinical Value of 3D Self-healing Elastic Liver Model for Surgical Training and Preoperative Planning: a Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comprehensive preoperative planning and real-time intraoperative guidance are essential prerequisites for achieving precise liver resection. In pursuit of this goal, the investigators have developed innovative 3D printed liver models utilizing a physically crosslinked self-healing elastomer created through the copolymerization of 4-acryloylmorpholine (ACMO) and methoxy poly (ethylene glycol) acrylate (mPEGA). These printed models exhibit exceptional healing capabilities, efficiently restoring their structure within minutes at room temperature, and rapidly recovering within moments after being incised.
Herein, the investigators aim to assess the viability of employing these 3D printed liver models as instrumental tools in designing the optimal surgical approach through an iterative trial-and-error methodology. Concurrently, the investigators aim to determine whether the integration of these 3D printed models into conventional methods (contrast-enhanced CT or MRI) can enhance the safety, ease, and efficiency of hepatic resection procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
3D Printed Model for preoperative planning
Intervention Description
Besides conventional preoperative planning based on contrast-enhanced CT/MRI, the investigator refers to a 3D printed model to determine the optimal surgical approach via a trial-and-error method. Specifically, a personalized 3D printed model is fabricated. By referring to the printed model and CT/MRI images, a preliminary surgical trace is determined. Then, a simulation surgery is performed on the model, and surgical margin and the potential injury of vital vascular structures are evaluated. This assessment leads to the adjustment of the surgical path as necessary. The refined surgical route is then validated through a second simulation surgery performed on the healed 3D model. This iterative process is repeated multiple times, allowing for a comprehensive exploration of various approaches until the optimal surgical strategy crystallizes. Next, the investigator proceeds to execute the real surgery on the participant, meticulously adhering to the determined optimal surgical approach.
Primary Outcome Measure Information:
Title
R0 resection rate
Description
The proportion of patients who achieved pathological negative surgical margin
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Injury of vital vascular structures
Description
The Injury of vital vascular structures, such as portal veins or hepatic veins.
Time Frame
Immediately after the surgery.
Title
Operation time
Description
Time length (minute) between the beginning and the end of the surgery.
Time Frame
Immediately after the surgery.
Title
Blood loss
Description
The amount of lost blood (ml) in the operation.
Time Frame
Immediately after the surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-80 years old;
Patients with a resectable tumor in the liver;
Eastern Cooperative Oncology Group Performance status score: 0;
Child-Pugh classification: A;
The Laboratory test results meet the following criteria and patients can tolerate surgery: Haemoglobin≥90g/L, Neutrophil count≥1.5×10⁹/L, Platelet count≥100×10⁹/L, Aspartate or alanine aminotransferase≤5 upper limits of normal(ULN）, alkaline phosphatase≤2.5 ULN, Serum albumin≥30g/L, serum creatinine<1.5 ULN, International normalized ratios（INR）≤2 or Prothrombin time（PT）exceed ULN≤6s, Creatinine clearance≥60 mL/min.
Exclusion Criteria:
Patients with extra-hepatic metastasis;
Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation in 28 days prior to the surgery;
Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy;
Severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease), uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L);
There are other unsuitable candidates for clinical trials, such as mental illness or alcohol dependence.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaoqun Fei
Phone
+086-0571-88122564
Email
ec@zjcc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuhua Zhang
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
1# Banshan East Rd. Zhejiang cancer hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhua Zhang, M.D.
Phone
+86-0571-88128058
Email
drzhangyuhua@126.com
First Name & Middle Initial & Last Name & Degree
Xing Chen
Phone
+86-19858152505
Email
chenxing@zjcc.org.cn
12. IPD Sharing Statement
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3D Printed Models for Liver Surgery
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