3D Printed Models for Liver Surgery

NCT06006338 | Unknown Phase 1

• 1 other identifier: ZYH-CX-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  The proportion of patients who achieved pathological negative surgical margin

  10 days

Secondary Outcomes (3)

• Injury of vital vascular structures

  Immediately after the surgery.

• Operation time

  Immediately after the surgery.

• Blood loss

  Immediately after the surgery.

Study Arms (1)

Experimental arm

EXPERIMENTAL

Other: 3D Printed Model for preoperative planning

Interventions

3D Printed Model for preoperative planning OTHER

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

1# Banshan East Rd. Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (1)

• Lu Y, Chen X, Han F, Zhao Q, Xie T, Wu J, Zhang Y. 3D printing of self-healing personalized liver models for surgical training and preoperative planning. Nat Commun. 2023 Dec 19;14(1):8447. doi: 10.1038/s41467-023-44324-6.

  PMID: 38114507 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Yuhua Zhang

  Zhejiang Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Chaoqun Fei

CONTACT

+086-0571-88122564; ec@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of Hepatobiliary and Pancreatic Surgery, Zhejiang Cancer Hospital

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 23, 2023
• Study Start: September 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 29, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)