Effectivity and Safety of Ultrasound-guided Percutaneously Laser Ablation for Refractory Neoplasms

Phase 1

• Conditions: Refractory Neoplasms
• Interventions: Procedure: US-guided laser ablation for refractory neoplasms

• Registration Number: NCT02822053
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-07-01
• Last Update Submitted: 2016-07-01
• Study First Posted: 2016-07-04
• Last Update Posted: 2016-07-04
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
US-guided laser ablation for refractory neoplasms	US-guided laser ablation for refractory neoplasms	The investigators used percutaneously US-guided laser ablation for patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Child-Pugh A/B, PLT ≥ 50\*10E9/L and PT ≤ 20s. Then the investigators estimated the safety and efficacy of this treatment through follow-up of US/CEUS/CT/MRI and the tumor markers every three months.

Primary Outcome Measures

Name	Time	Method
100 patients of refractory neoplasms with image-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