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Nerve Growth Factor in Chronic Pancreatitis

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT01255917
Collaborator
Stanford University (Other)
38
Enrollment
1
Location
42
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to understand the role of nerve growth factor(NGF) and other cytokines in the pancreatic fluid of patients with chronic pancreatitis.

Hypothesis:

  1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is not only a mechanical problem

  2. Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is variably expressed in different morphological stages of CP and regulates the sensitivity of the peptidergic nociceptors and is upregulated in pancreatic inflammation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    38 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Nerve Growth Factor in Chronic Pancreatitis
    Study Start Date :
    Feb 1, 2008
    Actual Primary Completion Date :
    Aug 1, 2011
    Actual Study Completion Date :
    Aug 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic pancreatitis

    Outcome Measures

    Primary Outcome Measures

    1. The levels of NGF in subjects with different morphological stages of chronic pancreatitis (CP) will be compared to the controls and in each morphological stage of CP will be correlated with pain scores. [5 years]

    Secondary Outcome Measures

    1. Correlate the expression of NGF and other inflammatory cytokines in the pancreatic juice in each morphological stage of CP. [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with established CP and none of the exclusion criteria mention below.
    Exclusion Criteria:

    • Failure to obtain consent.

    • Any comorbid condition with expected survival < 1 year.

    • Patients with pacemaker, implanted metallic prosthesis or other contraindications to do MRCP.

    • Patients < 18 years of age at time of consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University Medical Center Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University
    • Stanford University

    Investigators

    • Principal Investigator: Bimaljit S Sandhu, M.D, Associate Professor, VCU Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT01255917
    Other Study ID Numbers:
    • HM11033
    First Posted:
    Dec 8, 2010
    Last Update Posted:
    Mar 7, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Virginia Commonwealth University
    Tio identify role of NGF in pain in CP
    Identify biomarkers related to progression of CP
    Additional relevant MeSH terms:
    Pancreatitis
    Pancreatitis, Chronic

    Study Results

    No Results Posted as of Mar 7, 2016