Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN)With Alcohol in Unresectable Pancreatic Cancer: a Pilot Study

NCT ID: NCT00578279

Last Updated: 2012-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-06-30

Brief Summary

The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma.

Hypotheses:

1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.

2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL)

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

subject randomized to 10ml of dehydrated alcohol

Group Type: OTHER

dehydrated alcohol

Intervention Type: DRUG

subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure

B

subject randomized to 20ml of dehydrated alcohol

Group Type: EXPERIMENTAL

dehydrated alcohol

Intervention Type: DRUG

subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure

Interventions

dehydrated alcohol

subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A total of 20 consecutive subjects with locally advanced or unresectable pancreatic adenocarcinoma (stage II to IV) with pain (abdominal and/or back). Subjects with known or suspected unresectable pancreatic adenocarcinoma will be recruited for this study, as a diagnosis of unresectable pancreatic adenocarcinoma is often made during the endoscopic ultrasound (EUS) procedure.
• Subjects must have documented disease by computed tomography (CT), endoscopic retrograde cholangio-pancreatography (ERCP), or EUS.
• Subjects undergoing EUS for pancreatic cancer staging.
• Subjects undergoing pancreatic cancer surgery are eligible for study entry beginning 5 days after the operation if they have not had an intraoperative celiac plexus neurolysis.
• No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.

Subjects must not have a coagulopathy (platelet <50,000, INR>1.5, or bleeding disorder, or on blood thinners) Subjects with platelets below 50,000 will not be eligible to participate in this study due to the risk of bleeding. Patients will be asked to discontinue use of non-steroidals for 5 days prior to the procedure. Patients on plavix will be asked to discontinue use for 7 days prior to the procedure if they are clinically able to do so. Patients on coumadin or lovenox will also need to discontinue use prior to the procedure, but decisions regarding their management will be made on an individual basis as per our usual standards of care.

• Subjects must provide signed written informed consent.
• A baseline pain score is not required, however, subjects must be having pain that is requiring a stable dose of pain medication for control of pain.

Exclusion Criteria

• Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical).
• Presence of an implanted epidural or intrathecal analgesic therapy. Subjects with psychiatric illness that affects their ability to assess quality of life or compliance with the protocol.
• Subjects with uncorrectable coagulopathy
• Subjects with an allergy to bupivacaine or alcohol.
• Presence of an aneurysm in the abdominal aorta, celiac trunk, or superior mesenteric artery.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia LeBlanc, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Clarian Health: Indiana University Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

IRB # 0702-25

Identifier Type: -

Identifier Source: secondary_id

Clarian Values Grant: vfr-262

Identifier Type: -

Identifier Source: secondary_id

0702-25

Identifier Type: -

Identifier Source: org_study_id