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A Study of Serial Magnetic Resonance Cholangiopancreatography (MRCP) Following Morphine-neostigmine and Secretin Provocation in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01134848
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : June 2, 2010
Sponsor:
Information provided by:
University of Nottingham

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Sphincter of Oddi Dysfunction Drug: Morphine Drug: Neostigmine Drug: 0.9% saline Drug: Secretin Phase 4

Detailed Description:

The sphincter of Oddi (SO), which encases the distal common bile duct (CBD) and pancreatic duct (PD), comprises a fibromuscular complex to control the flow of biliary and pancreatic secretions into the duodenum. Aberrant function of the SO, known as Sphincter of Oddi dysfunction (SOD), can lead to recurrent episodes of biliary or pancreatic type pain. Both surgical sphincteroplasty and endoscopic sphincterotomy can improve symptoms in some patients who are suspected to have SOD. However, poor results are obtained in a significant proportion reflecting the difficulties in achieving an accurate diagnosis and also in selecting those patients likely to benefit from these procedures. A number of investigative modalities have been employed in the assessment of SOD. Of the available diagnostic tests sphincter of Oddi manometry (SOM) is considered the gold standard, but is associated with a high rate of post procedure morbidity including pancreatitis and biliary sepsis.

It is therefore unsurprising that attention has focussed on non-invasive diagnostic tests. Developments in magnetic resonance cholangiopancreatography (MRCP) have allowed for the detailed non-invasive assessment of biliary and pancreatic ductal morphology and can be used in conjunction with intravenous secretin provocation (ss-MRCP). Evaluations of this technique have so far been disappointing, demonstrating only a modest concordance with SOM in patients suspected with SOD.

The morphine-prostigmine provocation test (Nardi test) has previously been utilised as a screening test in patients with symptoms suggestive of SOD. It is performed by giving an intramuscular injection of morphine 10mg and prostigmine 1mg, with a positive test indicated by the reproduction of pain or a fourfold increase in either serum amylase or lipase levels. As enzymatic changes have been shown to occur in healthy subjects and in those with irritable bowel syndrome, the test has largely fallen out of favour. However, a recent publication has suggested morphine used as a pharmacological provocation agent can improve ductal distension and aid the differentiation of pancreaticobiliary variants on MRCP. To date this has not been investigated in a randomised or blinded study and we have therefore proposed to examine the effects of morphine-neostigmine and secretin provocation on gallbladder volume and biliary and pancreatic ductal morphology in healthy volunteers using serial MRCP.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomised, Double Blind Cross-over Study of Serial MRCP Following Morphine-neostigmine and Secretin Provocation in Healthy Volunteers
Study Start Date : January 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Morphine-neostigmine Drug: Morphine
10mg IM

Drug: Neostigmine
1mg IM

Drug: 0.9% saline
0.1 ml/kg

Active Comparator: Secretin Drug: Secretin
1 unit/kg IV

Drug: 0.9% saline
1ml IM




Primary Outcome Measures :
  1. Serum amylase (U/L) [ Time Frame: 0, 60, 120, 180 and 240 minutes ]
  2. Serum lipase (U/L) [ Time Frame: 0, 60, 120, 180 and 240 minutes ]
  3. Liver function tests [ Time Frame: 0, 60, 120, 180 and 240 minutes ]

Secondary Outcome Measures :
  1. Pancreatic duct diameter (mm) [ Time Frame: 0, 5, 30, 60, 90, 120, 150 and 180 minutes ]
  2. Pancreatic duct length (mm) [ Time Frame: 0, 5, 30, 60, 90, 120, 150 and 180 minutes ]
  3. Common bile duct diameter (mm) [ Time Frame: 0, 5, 30, 60, 90, 120, 150 and 180 minutes ]
  4. Gallbladder volume (mm3) [ Time Frame: 0, 5, 30, 60, 90, 120, 150 and 180 minutes ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134848


Locations
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United Kingdom
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Dileep Lobo, MBBS DM FRCS University of Nottingham
Study Director: Abeed Chowdhury, MB ChB BSc MRCS University of Nottingham

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Responsible Party: Paul Cartledge, University of Nottingham
ClinicalTrials.gov Identifier: NCT01134848     History of Changes
Other Study ID Numbers: C/10/2007
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: May 2010
Keywords provided by University of Nottingham:
Bile ducts
Sphincter of Oddi
Pancreatic ducts
Additional relevant MeSH terms:
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Biliary Dyskinesia
Cholinesterase Inhibitors
Sphincter of Oddi Dysfunction
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Morphine
Secretin
Neostigmine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists