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Clinical Trials/NCT02816944
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

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.

Registry
clinicaltrials.gov
Start Date
May 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 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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