Trial record 10 of 17 for:    celiac | Open Studies | United States

CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02054910
First received: January 29, 2014
Last updated: March 9, 2015
Last verified: March 2015
  Purpose
This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.

Condition Intervention
Small Duct Chronic Pancreatitis
Procedure: Celiac Plexus Block
Procedure: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Single Blinded Control Trial Comparing EUS Guided Celiac Plexus Block (CPB) Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in pain response over a 6 month period of time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pain scores will be assessed over two points on the VAS over a 6 month period of time. Assessment will be by a standard 11 point continuous visual analog scale pain score.


Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celiac Plexus Block
Celiac Plexus Block will be administered following EUS
Procedure: Celiac Plexus Block
Sham Comparator: Sham
A celiac plexus block will not be administered for pain management
Procedure: Sham

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients referred to UAB Endoscopy Unit for with known chronic pancreatitis
  • Patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi).

Exclusion Criteria:

  • Age <19 years
  • Unable to safely undergo EUS for any reason
  • Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
  • Unable to consent
  • Non-English speaking patients.
  • Previously undergone CPB
  • Pregnancy and Breast feeding
  • Patients with ductal strictures, calcification, pancreatic ductal calculi, pseudocysts.
  • Previous pancreatic surgery
  • Previous pseudocyst drainage
  • Other documented causes of abdominal pain.
  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: NCT02054910

Contacts
Contact: Jayapal Ramesh, MD 205-934-7964 jramesh@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jayapal Ramesh, MD    205-934-7964    jramesh@uab.edu   
Principal Investigator: Jayapal Ramesh, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
  More Information

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02054910     History of Changes
Other Study ID Numbers: F130822012 
Study First Received: January 29, 2014
Last Updated: March 9, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 25, 2016