Trial Outcomes & Findings for Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in Pancreatic Patients (NCT NCT01094561)

NCT ID: NCT01094561

Last Updated: 2016-09-09

Results Overview

The primary outcome studied will be the concordance of S-MRCP and S-EUS. Screening will consist of two diagnostic imaging modalities. First, all patients will have S-MRCP in conjunction with contrast-enhanced magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA). All images will be analyzed by a radiologist. Within thirty days, all patients will also undergo EUS with and without secretin enhancement (S-EUS).If the S-EUS shows abnormalities, EUS-guided fine-needle aspiration will be performed. The S-MRCP and EUS image findings will be classified as benign or suspicious/malignant to determine the concordance between imaging techniques. Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: Day 1 and up to 30 days after S-MRCP
• Results posted on: 2016-09-09

Participant Flow

Subjects were accrued from June 2007 to April 2011. All subjects were accrued and followed at Columbia University Medical Center.

Participant milestones

Measure	Synthetic Human Secretin Single arm (open label). Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
Overall Study STARTED	23
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in Pancreatic Patients

Baseline characteristics by cohort

Measure	Synthetic Human Secretin n=23 Participants Single arm (open label). Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
Age, Customized 18-29 years	0 participants n=5 Participants
Age, Customized 30-39 years	1 participants n=5 Participants
Age, Customized 40-49 years	2 participants n=5 Participants
Age, Customized 50-59 years	9 participants n=5 Participants
Age, Customized >60 years	11 participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and up to 30 days after S-MRCP

The primary outcome studied will be the concordance of S-MRCP and S-EUS. Screening will consist of two diagnostic imaging modalities. First, all patients will have S-MRCP in conjunction with contrast-enhanced magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA). All images will be analyzed by a radiologist. Within thirty days, all patients will also undergo EUS with and without secretin enhancement (S-EUS).If the S-EUS shows abnormalities, EUS-guided fine-needle aspiration will be performed. The S-MRCP and EUS image findings will be classified as benign or suspicious/malignant to determine the concordance between imaging techniques.

Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

The secondary outcome endpoints of our study will be positive predictive value of S-MRCP, in comparison with EUS/S-EUS and endoscopic retrograde cholangiopancreatography (ERCP), utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of Cancer Antigen 19-9 (CA 19-9) and oral glucose tolerance tests.

Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.

Outcome measures

Outcome data not reported

Adverse Events

Synthetic Human Secretin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Hecht, MD

Columbia University

Phone: (212)305-6510

Email: eh2560@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place