Status:

UNKNOWN

3D Printed Models for Liver Surgery

Lead Sponsor:

Zhejiang Cancer Hospital

Conditions:

Liver Cancer

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

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 i...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 29 2024

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT06006338

Start Date

September 15 2023

End Date

February 29 2024

Last Update

September 21 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

1# Banshan East Rd. Zhejiang cancer hospital

Hangzhou, Zhejiang, China, 310022