NCT02822053
Unknown
Phase 1
Effectivity and Safety of Ultrasound-guided Percutaneously Laser Ablation for Refractory Neoplasms
First Affiliated Hospital of Zhejiang University1 site in 1 country100 target enrollmentApril 2016
ConditionsRefractory Neoplasms
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Refractory Neoplasms
- Sponsor
- First Affiliated Hospital of Zhejiang University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 100 patients of refractory neoplasms with image-guided laser ablation-related effectivity as assessed by MRI
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ultrasonography (US) -guided laser ablation liver, kidney, pancreas, lung and retroperitoneal tumors, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter),
- •Patients with Child-Pugh A/B,
- •Patients with PLT ≥ 50\*10E9/L and PT ≤ 20s.
Exclusion Criteria
- •Patients with blood coagulation dysfunction, ChildPugh ≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.
Outcomes
Primary Outcomes
100 patients of refractory neoplasms with image-guided laser ablation-related effectivity as assessed by MRI
Time Frame: up to 24 months
Study Sites (1)
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