Nerve Growth Factor in Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

Nerve Growth Factor in Chronic Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255917
• Other study ID #: HM11033
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: March 3, 2016
• Start date: February 2008
• Est. completion date: August 2011

Study information

• Verified date: March 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Correlate the expression of NGF and other inflammatory cytokines in the pancreatic juice in each morphological stage of CP.		5 years	No