NCT02816944
Unknown
Phase 1
Effectivity and Safety of Endoscopic Ultrasonography-guided Laser Ablation for Refractory Neoplasms
First Affiliated Hospital of Zhejiang University1 site in 1 country80 target enrollmentMay 2016
ConditionsRefractory Neoplasms
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Refractory Neoplasms
- Sponsor
- First Affiliated Hospital of Zhejiang University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 80 patients of refractory neoplasms with EUS-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 endoscopic ultrasonography (EUS) guided laser ablation liver, pancreas, 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 refractory neoplasms including small hepatocellular carcinoma adjacent to the gastrointestinal tract, pancreatic neuroendocrine tumor, retroperitoneal tumor with 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 severe cardiopulmonary disease, intolerant endoscopy and anesthesia, upper gastrointestinal bleeding in shock, corrosive esophagitis and acute gastritis.
Outcomes
Primary Outcomes
80 patients of refractory neoplasms with EUS-guided laser ablation-related effectivity as assessed by MRI
Time Frame: up to 24 months
Study Sites (1)
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