Effectivity and Safety of Endoscopic Ultrasonography-guided Laser Ablation for Refractory Neoplasms

Phase 1

• Conditions: 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

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-29
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30
• Primary Completion: 2018-06
• Study Completion: 2018-06

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

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China