Trial Outcomes & Findings for MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics (NCT NCT02869893)

NCT ID: NCT02869893

Last Updated: 2020-08-07

Results Overview

Participants underwent MR imaging prior to and following secretin administration. Pre-secretin imaging lasts approximately 20 minutes. Post-secretin images were acquired at 1 minute, 5 minutes and 15 minutes following completion of secretin injection. Pre-secretin enteric fluid volumes were subtracted from post-secretin enteric fluid volumes for each participant to determine volume secreted in response to secretin administration at each time point. A commercially available software package determines the area of fluid signal on the MR images. The fluid signal from the pre-secretin images is then subtracted from the each post-secretin image (1, 5 and 15 minutes images) to determine the amount of fluid produced by the introduction of secretin.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: 35 minutes (20 min pre-secretin, 15 minutes post-secretin)
• Results posted on: 2020-08-07

Participant Flow

Participant milestones

Measure	Healthy Participants MRCP with Secretin and MR elastography will be performed on all participants. Secretin
Overall Study STARTED	57
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Healthy Participants MRCP with Secretin and MR elastography will be performed on all participants. Secretin
Overall Study participant aversion to IV	5
Overall Study participant fear of MRI scanner	2

Baseline Characteristics

MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics

Baseline characteristics by cohort

Measure	Healthy Participants n=50 Participants Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation. Secretin
Age, Customized 6-11 years	27 Participants n=5 Participants
Age, Customized 12-16 years	23 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 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	15 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 35 minutes (20 min pre-secretin, 15 minutes post-secretin)

Population: Healthy participants

Participants underwent MR imaging prior to and following secretin administration. Pre-secretin imaging lasts approximately 20 minutes. Post-secretin images were acquired at 1 minute, 5 minutes and 15 minutes following completion of secretin injection. Pre-secretin enteric fluid volumes were subtracted from post-secretin enteric fluid volumes for each participant to determine volume secreted in response to secretin administration at each time point.

A commercially available software package determines the area of fluid signal on the MR images. The fluid signal from the pre-secretin images is then subtracted from the each post-secretin image (1, 5 and 15 minutes images) to determine the amount of fluid produced by the introduction of secretin.

Outcome measures

Measure	Healthy Participants n=50 Participants Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation. Secretin
Total Secreted Fluid Volume as Measured by MR-PFT	79 mL Interval 32.0 to 162.0

SECONDARY outcome

Timeframe: Single time point, pre-secretin

Population: Of the 50 healthy controls recruited, complete MRE data were available for 49 subjects

Healthy controls underwent 3D MRE on a 1.5T scanner. Regions of interest for measurement of pancreatic stiffness were drawn by two blinded readers and statistical analysis were performed for comparisons between the 2 groups.

Outcome measures

Measure	Healthy Participants n=49 Participants Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation. Secretin
Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE)	1.7 kPa Standard Deviation 0.3

SECONDARY outcome

Timeframe: Single time point, pre-secretin

Pancreatic parenchymal volume by manual segmentation (tracing) of pancreas contours on magnetic resonance imaging (MRI)

Outcome measures

Measure	Healthy Participants n=50 Participants Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation. Secretin
Volumetric Measurement of Pancreatic Parenchymal Volume	46 mL Standard Deviation 18.8

Adverse Events

Healthy Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy Participants n=50 participants at risk MRCP with Secretin and MR elastography will be performed on all participants. Secretin
Gastrointestinal disorders Nausea	2.0% 1/50 • Number of events 1 • Approximately 2.5-3 hours Adverse events for this one visit study were collected from time of consent until completion of the study visit (approximately 2.5-3 hours)

Additional Information

Dr. Andrew Trout

Cincinnati Children's Hospital Medical Center

Phone: 513-803-3004

Email: andrew.trout@cchmc.org

Results disclosure agreements

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