Effectivity and Safety of Endoscopic Ultrasonography-guided Laser Ablation for Refractory Neoplasms
Phase 1
- Conditions
- Refractory Neoplasms
- Interventions
- Procedure: EUS-guided laser ablation for refractory neoplasms
- Registration Number
- NCT02816944
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EUS-guided laser ablation for refractory neoplasms EUS-guided laser ablation for refractory neoplasms -
- Primary Outcome Measures
Name Time Method 80 patients of refractory neoplasms with EUS-guided laser ablation-related effectivity as assessed by MRI up to 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China