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

Phase 1

• Conditions: Refractory Neoplasms
• Interventions: Procedure: Electroporation

• Registration Number: NCT02822066
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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.

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: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRE for refractory neoplasms in liver and pancreas	Electroporation	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.

Primary Outcome Measures

Name	Time	Method
60 patients of refractory neoplasms in liver and pancreas with irreversible electroporation-related effectivity as assessed by MRI	up to 24 months

Trial Locations

Locations (1)

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