Endoscopic Stenting for Chronic Abdominal Pain

This study has been completed.
Sponsor:
Collaborators:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Charles Mel Wilcox, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00754676
First received: September 17, 2008
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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


Condition
Chronic Pancreatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Randomized Single Blind Trial of Endoscopic Stenting for Chronic Pancreatitis-Associated Abdominal Pain

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Enrollment: 2
Study Start Date: October 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754676

Sponsors and Collaborators
Charles Mel Wilcox, MD
University of Alabama at Birmingham
Investigators
Principal Investigator: Charles M Wilcox, M.D. University of Alabama at Birmingham
  More Information

No publications provided

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, 5K24DK70629-05
Study First Received: September 17, 2008
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014