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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 22, 2008 | ||||
| Last Updated Date | January 27, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
MDCT-Images will be evaluated for quality, main and branch duct visualization, ductal diameter and improved visualization of structural abnormalities with and without use of RG1068. [ Time Frame: 1 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00620919 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Laboratory [ Time Frame: 2 ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis | ||||
| Official Title ICMJE | RG1068 (Synthetic Human Secretin) Enhanced Multidetector CT Pancreatography: Evaluation of the Pancreatic Duct in Patients With Known or Suspected Chronic Pancreatitis | ||||
| Brief Summary |
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| Detailed Description | Multidetector Computed Tomography (MDCT) is the mainstay of imaging for patients with acute or chronic pancreatitis, suspected pancreatic neoplasms and post-pancreatic surgery evaluation. The use of multidetector row helical CT scanners and sub-second gantry rotations, have dramatically reduced scan acquisition time with resultant improvement in patient compliance and image quality. The improved Z-axis (isotropic) resolution permits excellent image reconstructions, which play a critical role in diagnosis and staging of pancreatic pathologies, due to the anatomic layout of the pancreas and its vasculature. 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. However, this invasive procedure carries with it a significant potential for complications including acute pancreatitis, hemorrhage and infection, as well as reactions to contrast material or premedications and exposure to radiation. In addition, the success of such procedures - both from the standpoint of safety and efficacy - is highly dependent on the skill of the endoscopist [2], and the cost of ERCP is relatively high. Secretin enhanced MRCP (S-MRCP) has been extensively used in assessment of suspected pancreatic diseases. Likewise, administration of secretin intravenously to patients undergoing MDCT for the pancreas will result in improved distension of the pancreatic duct. The potential benefits of this would be a non-invasive evaluation of the pancreatic duct morphology. In patients with suspected abnormality involving the main duct or its side branches, the improved distension of the duct is likely to improve diagnostic yield for conditions such as intraductal papillary mucinous neoplasms (IPMNs) and cystic pancreatic neoplasms. This study is being undertaken to prospectively assess the effectiveness of RG1068-enhanced MDCT relative to unenhanced MDCT. RG1068 is a synthetic human secretin with a pharmacological profile very similar to that of biological and synthetic porcine secretins. Secretin is a 27-amino acid gastrointestinal peptide hormone that is produced by S-cells in the duodenum in response to the pH decrease caused by the passage of partially digested food from the stomach into the intestine. RG1068 is identical in amino acid sequence to naturally occurring human secretin and differs from porcine secretin in 2 amino acids. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Chronic Pancreatitis | ||||
| Intervention ICMJE | Drug: RG1068 (Synthetic Human Secretin) | ||||
| Study Arms / Comparison Groups | Experimental: Drug + MDCT | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | December 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00620919 | ||||
| Responsible Party | Dr. Dushyant Sahani, Massachusetts General Hospital | ||||
| Study ID Numbers ICMJE | 2006P002501 | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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