Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis

What Was Tested

The trial (phase 1) is built around Secretin.

It had 1 arm (groups): 1 (experimental).

Drug + MDCT.

The registry classes the interventions as drug.

More on the Plan

Multidetector Computed Tomography (MDCT) is the mainstay of imaging for patients with acute or chronic pancreatitis, suspected pancreatic neoplasms and post-pancreatic surgery evaluation.

Fast scanning time enables the acquisition of multiple phases of enhancement, which is of paramount importance in imaging the pancreas \[1\].

Until relatively recently, endoscopic retrograde cholangiopancreatography (ERCP) was the primary diagnostic and therapeutic modality for assessing patients with suspected pancreatic disease or abnormalities.

Secretin enhanced MRCP (S-MRCP) has been extensively used in assessment of suspected pancreatic diseases.

Who Took Part

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and females older than 18 years of age. Is clinically indicated for contrast-enhanced MDCT of the pancreas. Scheduled for MDCT and therapeutic or diagnostic ERCP for the assessment of chronic pancreatitis. Has been fully informed and has personally signed and dated the Written Informed Consent and Health Insurance Portability Accountability Act (HIPAA) provisions. Is able and willing to complete all study procedures specified in the protocol.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: has no clear written indication for contrast enhanced mdct of the pancreas; has a history of hypersensitivity to iodine-containing compounds; has congestive cardiac failure (class iii-iv in accordance with the classification of the new york heart association \[nyha\]).

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Everyone knew when Secretin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-02 with completion listed for 2008-12.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

It also tracked 1 secondary outcome, for example Laboratory.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Secretin in people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, all human trials.