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Clinical Trials/NCT02822053
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

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
June 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Sponsor

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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