Effectivity and Safety of Irreversible Electroporation for Refractory Neoplasms in Liver and Pancreas

Zhejiang University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Refractory Neoplasms

Treatments: Procedure: Electroporation

Study type: Interventional

Funder types: Other

Identifiers

NCT02822066

LA-003

Details and patient eligibility

About

The pupose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for refractory neoplasms in liver and pancreas, 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: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with hepatic portal focal lesion adjacent to important structures like bile duct and portal blood vessels, or intolerant surgery.
2. Patients with pancreatic cancer adjacent to blood vessels, or intolerant surgery.

Exclusion criteria

Patients with:

1. Metal in the body
2. ChildPugh ≥ 3
3. Long-term use of anticoagulant drugs including warfarin, clopidogrel bisulfate
4. Poor cardiac or renal function with intolerant surgery or anesthesia.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

IRE for refractory neoplasms in liver and pancreas

Experimental group

Description:

To evaluate the safety and efficacy of irreversible electroporation (IRE) for refractory neoplasms in liver and pancreas, 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.

Treatment:

Procedure: Electroporation