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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised, Double Blind Cross-over Study of Serial MRCP Following Morphine-neostigmine and Secretin Provocation in Healthy Volunteers

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.


Detailed Summary:

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 sho
Sponsor: University of Nottingham

Current Primary Outcome:

  • Serum amylase (U/L) [ Time Frame: 0, 60, 120, 180 and 240 minutes ]
  • Serum lipase (U/L) [ Time Frame: 0, 60, 120, 180 and 240 minutes ]
  • Liver function tests [ Time Frame: 0, 60, 120, 180 and 240 minutes ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pancreatic duct diameter (mm) [ Time Frame: 0, 5, 30, 60, 90, 120, 150 and 180 minutes ]
  • Pancreatic duct length (mm) [ Time Frame: 0, 5, 30, 60, 90, 120, 150 and 180 minutes ]
  • Common bile duct diameter (mm) [ Time Frame: 0, 5, 30, 60, 90, 120, 150 and 180 minutes ]
  • Gallbladder volume (mm3) [ Time Frame: 0, 5, 30, 60, 90, 120, 150 and 180 minutes ]


Original Secondary Outcome: Same as current

Information By: University of Nottingham

Dates:
Date Received: May 28, 2010
Date Started: January 2009
Date Completion:
Last Updated: June 1, 2010
Last Verified: May 2010