Secretin-Stimulated MRCP

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1 Gastrointestinal Imaging Original Research Mensel et al. Secretin-Stimulated MRCP Gastrointestinal Imaging Original Research Birger Mensel 1 Philip Messner 1 Julia Mayerle 2 Gabriele Fluhr 2 Henry Völzke 3 Markus M. Lerch 2 Till Ittermann 3 Jens-Peter Kühn 1 Mensel B, Messner P, Mayerle J, et al. Keywords: MRCP, pancreatic function tests, safety, secretin DOI: /AJR Received October 28, 2012; accepted after revision April 23, B. Mensel and J.-P. Kühn contributed equally to this work. This study was supported by CliRhoStim, the Deutsche Forschungsgemeinschaft (DFG GRK840-E3/E4, MA 4115/1-2/3, NI 1297/1-1), the Federal Ministry of Education and Research (BMBF GANI-MED A and BMBF ), and the European Union (EU-FP-7: EPC-TM and EU-FP7-REGPOT ). Funding for whole-body MRI examinations including secretin was provided by a joint grant from Siemens Healthcare, Erlangen, Germany, and the Federal State of Mecklenburg Western Pomerania. The University of Greifswald is a member of the Center of Knowledge Interchange program of Siemens AG. The Study of Health in Pomerania (SHIP) is part of the Community Medicine Research net of the University of Greifswald, Germany, which is funded by the Federal Ministry of Education and Research, the Ministry of Cultural Affairs, and the Social Ministry of the Federal State of Mecklenburg Western Pomerania. 1 Department of Diagnostic Radiology and Neuroradiology, University Medicine Greifswald, Ferdinand-Sauerbruch- Straße, D Greifswald, Germany. Address correspondence to B. Mensel (menselb@uni-greifswald.de). 2 Department of Internal Medicine, University Medicine Greifswald, Greifswald, Germany. 3 Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany. AJR 2014; 202: X/14/ American Roentgen Ray Society Secretin-Stimulated MRCP in Volunteers: Assessment of Safety, Duct Visualization, and Pancreatic Exocrine Function OBJECTIVE. The objective of our study was to investigate secretin-stimulated MRCP in terms of the safety of secretin, improvement of duct visualization, and assessment of pancreatic exocrine function. MATERIALS AND METHODS. Eight hundred sixteen volunteers (370 women and 446 men; mean age, 49.7 ± 13.1 [SD] years) underwent 3D MRCP before and after secretin stimulation (1 U/kg of body weight) at 1.5 T. For the first 2 hours after secretin injection, subjects were evaluated for adverse reactions. Improvement of duct visualization after secretin stimulation was subjectively evaluated by two readers and was quantified by duct diameter measurements. Pancreatic exocrine function was evaluated subjectively by two readers according to the duodenal filling and was quantified using calibrated volumetric measurements of total excreted volume and pancreatic flow output. RESULTS. Two subjects (0.2%) showed flushing (minor adverse reaction). Duct visualization after secretin injection was improved for reader 1 in 468 (57.4%) and for reader 2 in 478 (58.6%) subjects, was unchanged for reader 1 in 324 (39.7%) and for reader 2 in 315 (38.6%) subjects, and was worse for reader 1 in 24 (2.9%) and reader 2 in 23 (2.8%) subjects (interrater agreement, κ = 0.925). Main pancreatic duct diameters increased significantly after secretin stimulation: pancreatic head, 10.5% (mean); body, 12.5%; and tail, 7.7%. Pancreatic exocrine function evaluated according to assessment of duodenal filling was as follows: grade 0 (restricted function) in 0.7% of subjects by both readers, grade 1 (reduced function) in 4.8% of subjects by reader 1 and 4.5% of subjects by reader 2, grade 2 (low-grade reduced function) in 31.1% of subjects by reader 1 and 26.5% of subjects by reader 2, and grade 3 (physiologic function) in 63.4% of subjects by reader 1 and 68.3% of subjects by reader 2 (interrater agreement, κ = 0.838). The mean total excreted volume was ± 49.8 (SD) ml, and the mean pancreatic flow output was 9.6 ± 4.2 ml/min. CONCLUSION. Secretin-stimulated MRCP moderately improves main pancreatic duct visualization and allows noninvasive quantification of pancreatic exocrine function with a negligible risk of side effects. M RCP is a noninvasive method for evaluating the biliary and pancreatic ducts for diseases and is especially well suited for identifying morphologic signs of chronic pancreatitis [1]. In comparison with ERCP, the clinically accepted reference standard, MRCP carries no risk of severe complications, such as pancreatitis, which occurs after 3.5% of all ERCP procedures; infection, 1.4%; bleeding, 1.3%; or perforation, 0.6% [2]. Unlike other imaging-guided techniques, MRCP does not require the use of contrast agents or exposure to ionizing radiation. Since its introduction in 1991 [3], this technique has been tremendously improved in spatial reso- lution, facilitating the accurate assessment of major biliary and pancreatic diseases [4]. At this time, MRCP is a clinically accepted method with a high sensitivity and specificity for the diagnosis of diseases of the biliary and pancreatic ducts, particularly diseases that lead to stenosis or dilatation [5]. The sensitivity and specificity of MRCP for the detection of duct-associated pancreatic diseases can be improved by secretin stimulation [6, 7]. Synthetic secretin administration stimulates the pancreatic duct cells to secrete bicarbonate and also has a secondary effect on the sphincter of Oddi. These changes lead to dilatation of the pancreatic duct system, improving visualization of the main 102 AJR:202, January 2014

2 Secretin-Stimulated MRCP pancreatic duct (MPD) and delineation of the side branches [7]. However, as reported by Nicaise et al. [8], improved MPD visualization in secretin-stimulated MRCP is not observed consistently in all cases. The improvement in duct visualization achieved by secretin-stimulated MRCP has been investigated only in small groups of patients and has never been studied in a large population-based cohort of healthy volunteers with regard to self-reported or detected pancreatic disease [6, 7]. Furthermore, secretin-stimulated MRCP is also a noninvasive approach for estimating pancreatic exocrine function. In 1997, Matos et al. [7] reported their findings of a study of pancreatic exocrine function using secretin-stimulated MRCP, and their results were confirmed by other research groups [9 12]. Despite these advantages of secretinstimulated MRCP, it has not become widely accepted for the noninvasive evaluation of pancreatic exocrine function in the clinical setting. The main reasons for the lack of acceptance of secretin-stimulated MRCP appear to be the cost of secretin and the extra imaging time. Although the possibility of adverse reactions after secretin administration may also play a role, large clinical studies have reported no relevant adverse reaction caused by secretin [13]. Further, studies evaluating pancreatic exocrine function are limited to a small number of subjects and most are restricted to patients with suspected pancreatic disease [7, 9, 12]. The purpose of this study was to investigate the safety of secretin administration, improvement of duct visualization, and assessment of pancreatic exocrine function using secretin-stimulated MRCP in a large general population sample without overt pancreatic disorders taking part in the Study of Health in Pomerania (SHIP). Materials and Methods Study Population The study patients were recruited from the population-based SHIP; conducted in northeast Germany. SHIP was approved by the institutional review board, and informed consent was obtained from all subjects. The objectives of SHIP, an interdisciplinary prospective study, are to estimate the prevalence and incidence of risk factors and diseases and to investigate the complex associations among risk factors, subclinical disorders, and overt diseases [14]. For SHIP, participants underwent whole-body MRI examinations and were offered an optional conventional MRCP examination and a secretin-stimulated MRCP examination [15]. Between July 2008 and September 2011, 1004 volunteers (460 women and 544 men; mean age, 52.0 ± 13.4 [SD] years) were enrolled to investigate the clinical impact of secretin. Inclusion criteria were consent to administration of the drug secretin and serum pancreatic enzyme levels of lipase and amylase within the reference ranges (lipase, μkat/l; amylase, μkat/l). SHIP volunteers had a mean lipase value of 3.01 μkat/l (range, μkat/l) and a mean amylase value of 0.85 μkat/l (range, μkat/l). Exclusion criteria were signs of chronic pancreatitis detected by MRI or self-reported diseases of the pancreas. Further exclusion criteria were volunteers with chronic pancreatitis assessed as Cambridge stage 3 5 disease [16]. Excluded subjects included 15 subjects with cystic lesions at least 10 mm; 19 subjects with an MPD diameter of more than 4 mm; 128 subjects with dilatation or obstruction of the side branches; and 18 subjects with an obstruction, stenosis, or other abnormality of the MPD. Additionally, eight subjects were excluded because of poor image quality caused by respiratory motion. A total of 816 participants (370 women and 446 men; mean age, 49.7 ± 13.1 years) without overt pancreatic disorders satisfied the inclusion criteria and were enrolled. The demographic data of these subjects are presented in Table 1. MR Technique and Study Medication MRI was performed using a 1.5-T MRI system (Magnetom Avanto, Siemens Healthcare). Navigator-triggered T2-weighted 3D turbo spin-echo MRCP including an automatic maximum-intensity-projection (MIP) reconstruction was performed in the coronal orientation using the following imaging parameters: TR, approximately 900 ms (adapted to navigator-triggered data); long TE, 742 ms; bandwidth, 260 Hz/pixel; matrix, ; number of slices, 44; and slice thickness, 1.5 mm. The acquisition time for navigator-triggered MRCP was highly dependent on the size of the subject and ranged from 2 to 6 minutes. For each volunteer, MRCP was performed before secretin stimulation as a conventional MRCP study and was performed after secretin stimulation (Secrelux, Sanochemia Pharmazeutika AG) in the same orientation. A secretin dose of 1 U/kg of body weight was slowly injected by hand over 60 seconds and was followed by a 20-mL saline flush. Data Analysis Safety Subjects were assessed for adverse reactions for the first 2 hours after injection of secretin. Participants were monitored using ECG and pulse oximetry during the MR examination. After 2 hours, subjects were questioned with regard to symptoms including flushing, nausea, and malaise. Adverse reactions were documented and categorized as minor reactions (minimal clinical reactions without further consequence) or as major reactions (severe reactions with clinical consequence, such as the need for monitoring or admission to the ICU). Assessment of main pancreatic duct visualization Two readers independently assessed MPD dilatation before and after secretin stimulation using MIP reconstructions. A blinded reading of the datasets before and after secretin injection was not possible because secretin administration leads to obvious duodenal filling. MPD visualization on secretin-stimulated MRCP was classified into three groups: group 1, improved (progressive dilatation of MPD); group 2, unchanged (no dilatation of MPD); and group 3, worse (decreased visualization of MPD) (Fig. 1). Finally, a quantitative analysis of MPD diameters before and after secretin-stimulated MRCP was performed. One reader measured the MPD diameter at three defined landmarks before and after secretin stimulation using thin multiplanar reformatted datasets. The landmarks were the pancreatic head, body, and tail. In each subject, measurements on conventional MRCP and secretin-stimulated MRCP datasets were performed at identical positions while avoiding any imaging artifacts. Evaluation of pancreatic exocrine function Pancreatic exocrine function was evaluated subjectively using the criteria defined by Matos et al.: grade 0, no duodenal filling, restricted function; grade 1, filling limited to the duo- TABLE 1: Demographic Data of Subset of Subjects in Study of Health in Pomerania Who Underwent MRCP Characteristic Women (n = 370) Men (n = 446) Age (y) 49.3 ± ± 13.4 Body weight (kg) 71.9 ± ± 12.1 Height (m) 1.65 ± ± 0.1 Body mass index a 26.6 ± ± 3.5 Note Data are presented as mean ± SD. a Weight in kilograms divided by the square of height in meters. AJR:202, January

3 Mensel et al. A C E denal bulb, reduced function; grade 2, filling of descending part of duodenum, low-grade reduced function; and grade 3, complete duodenal filling, physiologic function [2, 7, 17] (Fig. 2). Two readers independently evaluated duodenal filling using MIP reconstructions of secretin-stimulated MRCP studies. After the subjective evaluation, pancreatic exocrine function was estimated by calculating the total excreted volume and pancreatic flow output using commercially available software (Voxar 3D, version 2.4, Toshiba Medical Visualization Systems). The calibration process and the definition of presets are described in detail in Appendix 1. In each subject, the total excreted volume and pancreatic flow output were quantified by semiautomatically determining the volume of bowel fluid before and after secretin stimulation (Fig. 3). Total excreted volume (TEV) was calculated as follows: TEV = FV SS-MRCP FV MRCP, where FV SS-MRCP is fluid volume on secretinstimulated MRCP and FV MRCP is fluid volume on conventional MRCP. Pancreatic flow output (PFO) was calculated as follows: PFO = TEV / t, where TEV is the total excreted volume and t is the time between secretin injection and the start of secretin-stimulated MRCP. Statistical Analysis Data are presented as means with SDs or numbers and percentages. Statistical significance was assumed at a p value of B D F Fig. 1 MRCP images obtained before and after secretin stimulation illustrate changes in main pancreatic duct (MPD) visualization after secretin stimulation. A and B, MPD visualization is improved. MRCP images obtained before (A) and after (B) secretin stimulation illustrate excellent response to secretin stimulation. Physiologic dilatation of MPD after injection is noted. C and D, MPD visualization is unchanged. MRCP images obtained before (C) and after (D) secretin stimulation illustrate no response to secretin stimulation. No response was noted in 42.5% of subjects by reader 1 and 41.3% of subjects by reader 2. E and F, MPD visualization is worse. MRCP images obtained before (E) and after (F) secretin stimulation show visualization of MPD is worse after secretin stimulation. For the subjective analyses, improvement of MPD visualization using secretin, and evaluation of pancreatic exocrine function using the criteria defined by Matos et al. [7], a second reader evaluated all datasets again. Interrater agreement was calculated by Cohen s kappa. The MPD diameters measured on conventional MRCP and secretin-stimulated MRCP were compared using the paired Student t test. Further, the results on duct visualization, Matos criteria, and calculated total excreted volume and pancreatic flow output values were stratified by time between secretin injection and the start of imaging. To analyze the influence of time on the quantified results of pancreatic exocrine function (i.e., total excreted volume, pancreatic flow output), we used a curve-fitting model. Data documentation and statistical analyses were performed using Excel (version 2007, Microsoft) and SigmaPlot (version 11.0, Systat Software). Results Minor adverse reactions were observed in two subjects (0.2%); both reported flushing of the entire body immediately after receiving the IV secretin injection. In both cases, the MRI examinations continued and the subjects had no further complaints. No changes in ECG or pulse oximetry were observed during the MR acquisition in any of the participants, and no major adverse events were observed. Both readers subjectively observed an improvement in duct visualization after secretin stimulation. MPD visualization was improved for reader 1 in 468 (57.4%) and for reader 2 in 478 (58.6%) subjects, was unchanged for reader 1 in 324 (39.7%) and for reader 2 in 315 (38.6%) subjects, and was worse for reader 1 in 24 (2.9%) and for reader 2 in 23 (2.8%) sub- 104 AJR:202, January 2014

4 Secretin-Stimulated MRCP jects (interrater agreement, κ = [range, ]). Table 2 presents the data on improvement in duct visualization by time from secretin injection. Improvement was nearly the same in all time groups between 7 and 20 minutes after injection. The MPD diameters of the pancreatic head, body, and tail measured on conventional MRCP and secretin-stimulated MRCP are listed in Table 3. Pancreatic exocrine function was evaluated in all 816 subjects according to the criteria of Matos et al. [7] by two readers as follows: grade 0 in six (0.7%) subjects by both readers, grade 1 in 39 (4.8%) subjects by reader 1 and 37 (4.5%) subjects by reader 2, grade 2 in 254 (31.1%) subjects by reader 1 and 216 (26.5%) subjects by reader 2, and grade 3 in 517 (63.4%) subjects by reader 1 and 557 (68.3%) subjects by reader 2. These results showed an interrater Fig. 3 Volume analysis for quantification of pancreatic exocrine function in 44-year-old male volunteer. In this case, interval between IV secretin injection and secretin-stimulated MRCP was 11 minutes. A and B, Conventional MRCP image obtained before secretin stimulation (A) and corresponding volumetry image (B). Volume of excreted duodenal fluid was 25 ml before secretin stimulation. C and D, Secretin-stimulated MRCP image (C) and corresponding volumetry image (D). Volume was 123 ml after secretin stimulation. Total excreted volume of 98 ml was determined by subtracting volume after secretin stimulation of 123 ml (measured on secretinstimulated MRCP) and before secretin stimulation of 25 ml (measured on conventional MRCP). Calculated pancreatic flow output was 8.9 ml/min. A C B D A C Fig. 2 Subjective evaluation of pancreatic exocrine function based on duodenal filling following criteria defined by Matos et al. [7]. In these four subjects, intervals between conventional MRCP and secretinstimulated MRCP are comparable (9 minutes for grades 1 and 2 and 10 minutes for grades 0 and 3). Secretin-stimulated MRCP images are shown. A, Grade 0 (no duodenal filling) in 63-year-old male volunteer. B, Grade 1 (filling limited to duodenal bulb) in 38-yearold female volunteer. C, Grade 2 (filling of descending part of duodenum) in 59-year-old male volunteer. D, Grade 3 (complete duodenal filling) in 51-year-old male volunteer. agreement (κ) of (range, ). The Matos criteria allow reliable estimates of pancreatic exocrine function regardless of the interval between secretin injection and MR data acquisition (Table 2). Quantitative analysis of pancreatic exocrine function was performed by measuring the volume of bowel fluid before and after secretin stimulation using TR-calibrated presets. The mean fluid volume on conventional MRCP was 54.0 ± 51.2 ml (SD), and the mean fluid volume on secretin-stimulated MRCP was ± 78.3 ml. The mean total excreted volume in the observation period of 6 22 minutes after secretin administration was calculated as ± 49.8 ml. The mean interval between secretin injection and data acquisition (i.e., secretin-stimulated MRCP) was 11.9 ± 2.8 minutes. The mean pancreatic flow output for all subjects was 9.6 ± 4.2 ml/min. The mean total excreted volume and pancreatic flow output values by time from secretin injection are listed in Table 2. The course of total excreted volume (TEV) 7 20 minutes after secretin injection (t) can be described as the following exponential function (R 2 = 0.91): TEV = exp(0.05 t). The course of pancreatic flow output (PFO) 7 20 minutes after secretin injection (t) can be described as the following exponential function (R 2 = 0.84): PFO = exp( 0.03 t). B D AJR:202, January

5 Mensel et al. TABLE 2: Results of Duct Visualization and Pancreatic Exocrine Function Assessments Improvement in Duct Visualization b, No. (%) of Subjects Time a (min) No. of Subjects Reader 1 Reader 2 Reader 1 Reader (55) 6 (55) ± ± (58) 33 (56) ± ± (59) 52 (61) ± ± (60) 75 (63) ± ± (56) 82 (58) ± ± (61) 78 (63) ± ± (54) 44 (53) ± ± (59) 38 (59) ± ± (59) 23 (59) ± ± (50) 16 (53) ± ± (50) 9 (50) ± ± (50) 10 (56) ± ± (50) 5 (50) ± ± (70) 7 (70) ± ± 2.7 Discussion Since 1995, some authors have been investigating the use of secretin-stimulated MRCP to increase the size of the MPD and improve MPD visualization in patients with pancreatic diseases [18]. Additionally, secretin-stimulated MRCP may have the potential to assist in the evaluation of pancreatic exocrine function [11]. On the other hand, secretin-stimulated MRCP has some limitations. The major drawbacks of secretin-stimulated MRCP include a longer acquisition time ( 5 15 minutes [waiting for secretin effect and extra scanning time]), the additional cost of secretin ( US $150 per adult dose), and the potential for adverse events. To our knowledge, there are no studies investigating the side effects of secretin in a large number of subjects recruited from the general population. Known adverse reactions to secretin are flushing and, less commonly, vomiting, diarrhea, fainting, blood clotting, fever, and rapid heartbeat. In more recent studies, patients who received IV injections of secretin experienced no major adverse events [6, 7, 13]. In our study population, only 0.2% of participants experienced minor adverse reactions (two subjects flushed), and Percentage of Subjects With Pancreatic Exocrine Function Assessed as Grade 2 or 3 c no major events occurred within 2 hours of secretin administration; these results confirm that secretin is safe. After evaluating more than 4000 MRCP examinations, Sandrasegaran et al. [13] concluded that the maximum increase in duct diameter in healthy subjects occurs within 7 10 minutes of secretin stimulation. Results concerning the optimal time for MPD imaging after secretin stimulation are inconsistent. In patients with pancreatic disease, Manfredi et al. [10] observed the maximal duct diameter to be 3 minutes after secretin stimulation, whereas Fukukura et al. [19] found the diameters to be largest 4 5 minutes after secretin stimulation. In our study, we did not observe an improvement in duct visualization after secretin stimulation in all cases. In the readers subjective assessment, duct diameter improved in only approximately 60% of all subjects. It is possible that the interval between secretin injection and MR data acquisition (mean, 11.9 minutes) was too long. However, stratifying volunteers by time from secretin injection revealed no differences in improvement between longer and shorter intervals for the range analyzed (7 20 minutes), suggesting that the delay has only a little effect on how Total Excreted Volume d (ml), Mean ± SD Pancreatic Flow Output e (ml/min), Mean ± SD Note Three subjects imaged 6, 21, and 22 minutes after secretin injection are not included in stratification by time interval. a Time interval between secretin injection and data acquisition. b Improved duct visualization was observed by readers 1 and 2 in approximately 60% of subjects independent of the time from injection. c Pancreatic exocrine function was subjectively evaluated by criteria proposed by Matos et al.: grade 0, no duodenal filling, restricted function; grade 1, filling limited to the duodenal bulb, reduced function; grade 2, filling descending part of duodenum, low-grade reduced function; and grade 3, complete duodenal filling, physiologic function [2, 7, 17]. No relevant differences in pancreatic exocrine function were seen between different time points after injection (summary of grades 2 and 3). d Total volume of excreted duodenal fluid increased over time. e Pancreatic flow output decreased over time. much secretin improves duct visualization. In approximately 3% of subjects, visualization of the ducts was worse after secretin administration. A clinical explanation for our finding would be the presence of chronic pancreatitis. In chronic pancreatitis, tissue stiffness increases as a result of fibrosis and, therefore, duct dilatation in response to secretin stimulation is limited. However, in our study setting, we regard this phenomenon as unlikely because we excluded all subjects with overt pancreatic disease. It is noteworthy that if the same study had been conducted in a clinical setting, those subjects could likely have been misdiagnosed with chronic fibrosing pancreatitis. Our quantitative analysis of duct diameters revealed significant increases in duct diameters after secretin stimulation in the pancreatic head, body, and tail. Our results are comparable with dynamic data from Manfredi et al. [10] and Fukukura et al. [19] acquired 10 minutes after secretin injection. Today, basic noninvasive approaches to quantify pancreatic exocrine function are available; one of the most promising is secretin-stimulated MRCP [20]. However, it is not possible to evaluate enzyme secretion or bicarbonate concentration using secretin-stimulated MRCP. 106 AJR:202, January 2014

6 Secretin-Stimulated MRCP TABLE 3: Mean Diameters of Main Pancreatic Duct (MPD) at Head, Body, and Tail Measured on Conventional MRCP and Secretin-Stimulated MRCP Diameter of MPD (mm) Imaging Modality Head Body Tail Conventional MRCP, mean ± SD 1.9 ± ± ± 0.4 Secretin-stimulated MRCP, mean ± SD 2.1 ± ± ± 0.4 Δ 0.2 (10.5%) 0.2 (12.5%) 0.1 (7.7%) p < < < In 1997, Matos et al. [7] observed continuous progression in duodenal filling after secretin stimulation and described these findings using subjective criteria to evaluate pancreatic exocrine function. Duodenal filling was reported to be significantly reduced in patients with chronic pancreatitis [17]. Classification of duodenal filling according to Matos et al. allows an estimation of pancreatic exocrine function and shows excellent correlation with the invasive tube test [9]. In the study of Manfredi et al. [10], who used duodenal filling to assess pancreatic function in patients, high-grade pancreatic dysfunction (grade 0 according to Matos et al.) was found in 1.2% of cases, moderate dysfunction (grade 1) in 4.8%, and low-grade dysfunction (grade 2) in 8.3%. Most patients (85.7%) had normal pancreatic function (grade 3) [10]. Although the prevalences in our study of grade 0 (readers 1 and 2, 0.7%) and grade 1 (reader 1, 4.8%; reader 2, 4.5%) are similar to their results [10], we obtained different results for grade 2 (reader 1, 31.1%; reader 2, 26.5%) and grade 3 (reader 1, 63.4%; reader 2, 68.3%). A quantitative approach for assessing pancreatic exocrine function is to evaluate the volume of duodenal fluid after secretin stimulation and calculate pancreatic flow output. In 2001, Heverhagen et al. [11] estimated fluid output after secretin stimulation as determined with a static MR technique acquired after 10 minutes; this technique is known as MR hydrometry. Heverhagen et al. found an excellent correlation (r = 0.946, p < 0.05) with the tube test in five patients [11]. In 2003, Punwani et al. [12] showed a linear relationship between duodenal filling volumes over the course of an experiment in 11 patients and assumed that flow output is a biomarker for pancreatic exocrine function (mean, 8.1 ± 2.5 ml/ min; range, ml/min). To date, the distribution of normal pancreatic flow output determined by MRI in a cohort without overt pancreatic disorders is still unknown. Previous MR studies investigated small numbers of subjects totaling 56 healthy subjects; in these four studies, mean values for pancreatic flow output were calculated to range from 6.4 to 7.4 ml/min [21 24]. In contrast to these studies, our calculation is based on 816 participants sampled from the general population and yielded a comparable mean pancreatic flow output of 9.6 ± 4.2 ml/min. The slightly higher value in our study is attributable to the fact that we included only subjects without clinical indications requiring imaging. In agreement with studies by Bali et al. [23] and Punwani et al., the total excreted volume in our study increased over time. However, we observed a time-dependent decrease in pancreatic flow output, which can be described using an exponential function. To date, MRI data could not be compared with data from endoscopic procedures because time was not considered. Using our pancreatic flow output calibration, we calculated pancreatic flow output after 60 minutes to be approximately 2.3 ml/min, which is comparable to values determined in endoscopic studies [25]. There are limitations of our study that should be noted. First, we included only volunteers without overt pancreatic disease. There was no clinical follow-up of subjects. Second, we chose to perform high-spatialresolution imaging with 3D MRCP rather than single-shot MRCP. Single-shot MRCP would have allowed the acquisition of multiple time points and may have improved evaluation of pancreatic exocrine function. A third limitation is that the interval between conventional MRCP and secretin-stimulated MRCP was relatively long (mean, 11.9 minutes). As we discussed earlier, previous studies used an interval of 3 10 minutes [10, 13, 19]. The longer time in our study was required to accommodate multiple scanning protocols performed as part of the overall whole-body MRI examination. In conclusion, our results suggest that the side effects of the drug secretin are minimal and that the use of secretin-stimulated MRCP moderately improves MPD visualization in healthy volunteers. Additional studies are needed to determine the optimal time point of image acquisition after secretin injection. Noninvasive assessment of pancreatic exocrine function using the criterion of duodenal filling, as suggested by Matos et al. [7], best characterizes low-grade reductions in pancreatic exocrine function. Measurements of total excreted volume and pancreatic flow output showed comparable results in a large population-based study of volunteers without overt pancreatic disorders. Acknowledgment We are especially grateful to CliRhoStim for their continuous support of this study. References 1. Czakó L. Diagnosis of early-stage chronic pancreatitis by secretin-enhanced magnetic resonance cholangiopancreatography. J Gastroenterol 2007; 42(suppl 17): Andriulli A, Loperfido S, Napolitano G, et al. Incidence rates of post-ercp complications: a systematic survey of prospective studies. Am J Gastroenterol 2007; 102: Wallner BK, Schumacher KA, Weidenmaier W, Friedrich JM. Dilated biliary tract: evaluation with MR cholangiography with a T2-weighted contrast-enhanced fast sequence. Radiology 1991; 181: Maccioni F, Martinelli M, Al Ansari N, et al. Magnetic resonance cholangiography: past, present and future a review. Eur Rev Med Pharmacol Sci 2010; 14: Soto JA, Castrillón GA. Clinical applications of magnetic resonance cholangiopancreatography [in Spanish]. Radiologia 2007; 49: Schlaudraff E, Wagner HJ, Klose KJ, Heverhagen JT. Prospective evaluation of the diagnostic accuracy of secretin-enhanced magnetic resonance cholangiopancreaticography in suspected chronic pancreatitis. Magn Reson Imaging 2008; 26: Matos C, Metens T, Devière J, et al. Pancreatic duct: morphologic and functional evaluation with dynamic MR pancreatography after secretin stimulation. Radiology 1997; 203: Nicaise N, Pellet O, Metens T, et al. Magnetic resonance cholangiopancreatography: interest of IV secretin administration in the evaluation of pancreatic ducts. Eur Radiol 1998; 8: Cappeliez O, Delhaye M, Devière J, et al. Chronic pancreatitis: evaluation of pancreatic exocrine function with MR pancreatography after secretin stimulation. Radiology 2000; 215: Manfredi R, Costamagna G, Brizi MG, et al. Severe chronic pancreatitis versus suspected pancreatic disease: dynamic MR cholangiopancreatog- AJR:202, January

7 Mensel et al. raphy after secretin stimulation. Radiology 2000; 214: Heverhagen JT, Muller D, Battmann A, et al. MR hydrometry to assess exocrine function of the pancreas: initial results of noninvasive quantification of secretion. Radiology 2001; 218: Punwani S, Gillams AR, Lees WR. Non-invasive quantification of pancreatic exocrine function using secretin-stimulated MRCP. Eur Radiol 2003; 13: Sandrasegaran K, Lin C, Akisik FM, Tann M. State-of-the-art pancreatic MRI. AJR 2010; 195: Völzke H, Alte D, Schmidt CO, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol 2011; 40: Hegenscheid K, Kühn JP, Völzke H, Biffar R, Hosten N, Puls R. Whole-body magnetic resonance imaging of healthy volunteers: pilot study results from the population-based SHIP study. Rofo 2009; 181: Balcı C. MRI assessment of chronic pancreatitis. Diagn Interv Radiol 2011; 17: Calculli L, Pezzilli R, Fiscaletti M, Casadei R, Brindisi C, Gavelli G. Exocrine pancreatic function assessed by secretin cholangio-wirsung magnetic resonance imaging. Hepatobiliary Pancreat Dis Int 2008; 7: Takehara Y, Ichijo K, Tooyama N, et al. Enhanced delineation of the pancreatic duct in MR cholangiopancreatography (MRCP) with a combined use of secretin [in Japanese]. Nippon Igaku Hoshasen Gakkai Zasshi 1995; 55: Fukukura Y, Fujiyoshi F, Sasaki M, Nakajo M. Pancreatic duct: morphologic evaluation with MR cholangiopancreatography after secretin stimulation. Radiology 2002; 222: Merkle EM, Nelson RC. Dual gradient-echo inphase and opposed-phase hepatic MR imaging: a useful tool for evaluating more than fatty infiltration or fatty sparing. RadioGraphics 2006; 26: Bali MA, Golstein P, Devière J, Chatterjee N, Matos C. Evaluation of somatostatin inhibitory effect on pancreatic exocrine function using secretin-enhanced dynamic magnetic resonance cholangiopancreatography: a crossover, randomized, double blind, placebo-controlled study. Pancreas 2006; 32: APPENDIX 1: Definition of Presets for Quantifying Pancreatic Exocrine Function Similar to earlier investigators [12], we assumed that there were no differences in signal intensities between water and secretin-stimulated pancreatic juice. On the basis of this assumption, one can perform a simple calibration procedure using a water phantom. Images in our study were acquired with a range of different TRs resulting from automatic adjustment using navigator gating. To account for the resulting differences in the signal intensities of bowel fluid, we Volume of Water in Phantom Based on MRI Measurements (ml) Volume of Water in Phantom (ml) Fig. 4 Phantom scanning was performed using nontriggered MRCP sequences with TRs between 2000 and 5000 ms (in steps of 500 ms) to prepare TR-specific presets. Volume analysis depends on intensity of varying TRs, which were automatically adapted by navigator-triggered MRCP. Graph shows that correlation between actual volume of water in phantom and volume of water in phantom measured by MRI was excellent (Pearson correlation coefficient, r = 0.999; p < 0.001) for different TR values from MRI. 22. Bali MA, Sontou R, Arvanitakis M, Metens T, Devière J, Matos C. Evaluation of the stimulating effect of a low dose of secretin compared to the standard dose on the exocrine pancreas with MRCP: preliminary results in normal subjects (MRCP quantification of secretin stimulation). Abdom Imaging 2007; 32: Bali MA, Sztantics A, Metens T, et al. Quantification of pancreatic exocrine function with secretinenhanced magnetic resonance cholangiopancreatography: normal values and short-term effects of pancreatic duct drainage procedures in chronic pancreatitis initial results. Eur Radiol 2005; 15: Gillams AR, Lees WR. Quantitative secretin MRCP (MRCPQ): results in 215 patients with known or suspected pancreatic pathology. Eur Radiol 2007; 17: Gregg JA, Sharma MM. Endoscopic measurement of pancreatic juice secretory flow rates and pancreatic secretory pressures after secretin administration in human controls and in patients with acute relapsing pancreatitis, chronic pancreatitis, and pancreatic cancer. Am J Surg 1978; 136: used a phantom calibration method. To this end, TR-dependent presets based on calculations made by software (Voxar 3D, version 2.4, Toshiba Medical Visualization Systems) were prepared using water phantoms of 0, 25, 50, 75, and 100 ml. Phantom calibration was performed to determine thresholds for TRs in steps of 500 ms. For all thresholds defined in this way, excellent correlation (Pearson correlation coefficient, r = 0.999; p < 0.001) was observed (Fig. 4). r = (CI, ); p < AJR:202, January 2014

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