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

Zhejiang University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Refractory Neoplasms

Treatments: Procedure: US-guided laser ablation for refractory neoplasms

Study type: Interventional

Funder types: Other

Identifiers

NCT02822053

LA-002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

US-guided laser ablation for refractory neoplasms

Experimental group

Description:

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.

Treatment:

Procedure: US-guided laser ablation for refractory neoplasms