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

Zhejiang University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Refractory Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02816944

LA-004

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

EUS-guided laser ablation for refractory neoplasms

Experimental group

Treatment:

Procedure: EUS-guided laser ablation for refractory neoplasms