Randomized Trial of EUS Neurolysis in Pancreas Cancer - Full Text View

Purpose

This is a clinical trial to determine more effective methods of controlling the pain in pancreatic cancer. Although narcotic pain medication are effective, they have many side effects and are underutilized due to social stigma and fear of addiction. Celiac plexus neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled clinical trials. We hypothesized that celiac plexus neurolysis plus pain medication will be more effective and have fewer side effects than pain medication alone. We are evaluating the effectiveness of this standard pain medications with or without celiac plexus neurolysis in a randomized controlled trial. One half of the participants will receive pain medications only and the other half will receive pain medications plus neurolysis, delivered via an endoscopic ultrasound device placed in the stomach.

Condition	Intervention	Phase
Pancreatic Neoplasms	Procedure: Celiac Plexus Neurolysis	Phase III

MedlinePlus related topics:

Ataxia Telangiectasia Cancer Celiac Disease Pancreatic Cancer

Drug Information available for:

Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Official Title:	Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

To evaluate the efficacy of treatment of ethanol injection versus placebo
injection for pain in pancreatic cancer patients at 1 month and 3 months.

Secondary Outcome Measures:

To evaluate mortality and surgical morbidity at 1 month and 3 months
To evaluate magnitude of narcotic use after treatment at 1 month and 3 months
To estimate the period of time pain scores will remain below baseline levels
To estimate the effect of treatment on quality of life at 1 month and 3 month

Estimated Enrollment:	26
Study Start Date:	August 2004

Detailed Description:

This is a phase III randomized blinded sham controlled trial of endoscopic ultrasound guided celiac plexus neurolysis. Patients with pancreatic cancer who are unresectable and who have significant pain (> 3 on 0-10 scale) will be enrolled. At the time of a staging endoscopic ultrasound, patients will be randomized to celiac neurolysis or sham (injection of same medication into lumen of stomach). Neurolysis will be performed using standard bupivicaine and ethanol. Patients will be followed for at least 3 months for pain, quality of life and narcotic usage.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

3.1 Unresectable (T4 or M1 or non-regional lymph nodes) or inoperable (due to medical comorbidity) carcinoma of the pancreas as determined by CT or EUS. Patients with extensive portal vein or superior mesenteric vein involvement (T3 by 6th Ed. AJCC staging manual) will be included only if the consulting surgeon feels the patients is unresectable based on the CT scan information.

3.2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at least 1 hour per day.

3.3 No known coagulopathy as measured by Prothrombin time (INR) 1.5. Pre-EUS INR is not required unless clinically indicated due to known warfarin use or suspected coagulopathy.

3.4 Patient must not require more than 2 l/min oxygen supplementation to maintain saturation >90%.

3.5 > 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since previous surgery. 3.7 No institution or change in chemotherapy or radiotherapy within 7 days prior (or 14 days post) ESU-CPN. See section 7.0 and 7.1 for details of chemotherapy and radiotherapy allowances.

3.8 Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to known or suspected coagulopathy.

3.9 Life expectancy > 3 months 3.10 Signed and dated informed consent.

Exclusion Criteria:

Unable to sign informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279292

Locations


United States, Arizona
	Mayo Clinic Scottsdale
	Scottsdale, Arizona, United States, 85259

United States, Florida
	Mayo Clinic Jacksonville
	Jacksonville, Florida, United States, 32224

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators


Principal Investigator:	Michael B Wallace, MD MPH	Mayo Clinic

More Information

Study ID Numbers:	DK69947
First Received:	January 17, 2006
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00279292
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Pancreatic neoplasm

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Pancreatic Neoplasms

Endocrine System Diseases

Pancreatic Diseases

Gastrointestinal Neoplasms

Pain

Celiac Disease

Endocrinopathy

Pancrelipase

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00279292