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Endoscopic Stenting for Chronic Abdominal Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00754676
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : December 6, 2011
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The prospective sham randomized study will evaluate the role of endoscopic stenting inpatients with chronic pancreatitis and chronic abdominal pain.

Condition or disease
Chronic Pancreatitis

Detailed Description:

Endoscopic stenting is increasingly used for the treatment of a variety of pancreatic disorders. Although a number of studies suggest that pancreatic stenting relieves abdominal pain in approximately 70% of patients, there has been no randomized study. Since any intervention may improve pain, the effectiveness of endoscopy cannot be ascertained without a true placebo arm or sham therapy group.

The study will aim to determine the effectiveness of pancreatic stents in relieving chronic pain in the setting of chronic pancreatitis. Since these procedures do carry risk, a placebo controlled fashion is used for this study


Study Design

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Randomized Single Blind Trial of Endoscopic Stenting for Chronic Pancreatitis-Associated Abdominal Pain
Study Start Date : October 2004
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women diagnosed with chronic pancreatitis.
Criteria

Inclusion Criteria:

  • All patients referred to the principal investigator for chronic pancreatitis will be enrolled.

Exclusion Criteria:

  • There are no gender nor racial exclusion.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754676


Sponsors and Collaborators
Charles Mel Wilcox, MD
National Institutes of Health (NIH)
University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Charles M Wilcox, M.D. University of Alabama at Birmingham
More Information

Responsible Party: Charles Mel Wilcox, MD, Principle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00754676     History of Changes
Other Study ID Numbers: F040924005
5K24DK070629-05 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Pancreatitis
Abdominal Pain
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive