Sphincter of Oddi Dysfunction Clinical Trial
Official title:
A Randomised, Double Blind Cross-over Study of Serial MRCP Following Morphine-neostigmine and Secretin Provocation in Healthy Volunteers
The sphincter of Oddi is a circular band of muscle which controls the flow of pancreatic
juices and bile into the small intestine. Abnormal function of the Sphincter of Oddi, known
as Sphincter of Oddi dysfunction (SOD), can lead to recurrent episodes of abdominal pain.
Making a diagnosis of SOD is difficult and is currently achieved using an invasive pressure
test. This pressure test is associated with some adverse effects including inflammation of
the pancreas gland. We are investigating an alternative test in which medication is given to
provoke spasm of the sphincter. Following provocation, blood can be sampled to detect
changes in blood composition and changes in sphincter anatomy can be evaluated using
specialized imaging techniques.
Our aim is to study and compare the effects of two provocation medications
(morphine-prostigmine and secretin) on biliary and pancreatic ductal anatomy, using dynamic
serial MRCP in healthy volunteers.
Our hypothesis is that morphine-neostigmine provocation results in greater changes in
biliary and pancreatic ductal anatomy when assessed using dynamic serial MRCP.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Healthy age matched and sex matched volunteers - No history of chronic abdominal pain - No previous abdominal surgery - No history suggestive of gastrointestinal motility disorders - No history of regular medication or substance abuse Exclusion Criteria: - Acute illness within preceding 6 weeks - Participation in another study within 3 months - Allergy to morphine or neostigmine - Pregnancy - Refusal to consent to the study |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Nottingham | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum amylase (U/L) | 0, 60, 120, 180 and 240 minutes | No | |
Primary | Serum lipase (U/L) | 0, 60, 120, 180 and 240 minutes | No | |
Primary | Liver function tests | 0, 60, 120, 180 and 240 minutes | No | |
Secondary | Pancreatic duct diameter (mm) | 0, 5, 30, 60, 90, 120, 150 and 180 minutes | No | |
Secondary | Pancreatic duct length (mm) | 0, 5, 30, 60, 90, 120, 150 and 180 minutes | No | |
Secondary | Common bile duct diameter (mm) | 0, 5, 30, 60, 90, 120, 150 and 180 minutes | No | |
Secondary | Gallbladder volume (mm3) | 0, 5, 30, 60, 90, 120, 150 and 180 minutes | No |
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