Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer

Boston Scientific

Status and phase

Terminated

Phase 1

Conditions

Pain

Pancreatic Cancer

Treatments

Procedure: Cryoablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01335945

CUC10-PAN09

Details and patient eligibility

About

CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.

Full description

CUC10-PAN09 is a Supportive Care, Phase 1 multicenter, prospective, single arm study with subjects serving as their own control. This study is to enroll patients who will undergo cryoablation of the Celiac Plexus. Subjects will be followed for 3 months post their cryoablation procedure.

Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must be at least 18 years old
Subject has unresectable or inoperable pancreatic carcinoma as determined by CT or MRI
Subject's epigastric/abdominal 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) on the BPI despite pharmaceutical pain management
ECOG of 0-3
Platelet count >50,000
INR <1.5

Exclusion criteria

Subject's life expectancy is <3 months
Subject has current neutropenia (ANC <1000)
Subject unable to undergo CT or MRI
Subject had previous ETOH neurolytic block for pancreatic cancer-related pain less than 2 weeks from screening
Subject had surgery <4 weeks from screening