Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.
Department of Medicine, University of Minnesota, Minneapolis, Minnesota.
Gastroenterology. 2014 Sep;147(3):646-654.e2. doi: 10.1053/j.gastro.2014.05.035. Epub 2014 Jun 4.
BACKGROUND & AIMS: Administration of secretin improves noninvasive imaging of the pancreatic duct with magnetic resonance cholangiopancreatography (MRCP). We performed a large prospective study to investigate whether synthetic human secretin (RG1068)-stimulated MRCP detects pancreatic duct abnormalities with higher levels of sensitivity than MRCP.
We performed a phase 3, multicenter, baseline-controlled study of patients with acute or acute recurrent pancreatitis who were scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP) between March 26, 2008, and October 28, 2009. Patients underwent a baseline MRCP that was immediately followed by administration of RG1068 and repeat MRCP and then underwent ERCP within 30 days; they were followed up for 30 days. MRCP and ERCP images were read centrally by 3 radiologists and 2 endoscopists, respectively, who were all independent and blinded; pancreatic duct abnormalities were evaluated. The accuracy of MRCP was evaluated using ERCP as the standard.
In total, 258 patients were enrolled in the study; 251 MRCP image sets were assessed, and 236 patients had evaluable ERCPs. Pancreatic duct abnormalities were observed in 60.2% of ERCP images. All radiologists identified duct abnormalities in RG1068-ciné MRCP image sets with significantly higher levels of sensitivity (P < .0001) than in images from MRCP, with minimal loss of specificity. Adverse events were reported in 38.0% of patients after MRCP and 68.1% after ERCP. Of the 55 patients who experienced a serious adverse event, 3 (1.2%) and 52 (20.5%) of the events were reported to be temporally associated with MRCP and ERCP, respectively. The adverse events most frequently considered related to RG1068 were nausea, abdominal pain, and flushing; most were mild.
Compared with images from MRCP, those from RG1068-stimulated MRCP are improved in many aspects and could aid in diagnosis and clinical decision making for patients with acute, acute recurrent, or chronic pancreatitis. RG1068-enhanced MRCP might also better identify patients in need of therapeutic ERCP (ClinicalTrials.gov, Number: NCT00660335).
促胰液素的给药可改善磁共振胰胆管成像（MRCP）对胰管的无创成像。我们进行了一项大型前瞻性研究，旨在探讨合成人促胰液素（RG1068）刺激的 MRCP 是否比 MRCP 更能提高胰管异常的检出率。
我们进行了一项 3 期、多中心、基线对照研究，纳入了 2008 年 3 月 26 日至 2009 年 10 月 28 日期间计划行内镜逆行胰胆管造影术（ERCP）的急性或复发性胰腺炎患者。患者先进行基线 MRCP，然后立即给予 RG1068 并重复 MRCP，随后在 30 天内行 ERCP；随访 30 天。3 名放射科医生和 2 名内镜医生分别对 MRCP 和 ERCP 图像进行中心读片，均为独立盲法读片；评估胰管异常。以 ERCP 为标准评估 MRCP 的准确性。
共纳入 258 例患者；评估了 251 套 MRCP 图像，236 例患者有可评估的 ERCP。ERCP 图像中观察到胰管异常占 60.2%。所有放射科医生均发现 RG1068 电影 MRCP 图像组中的胰管异常，其敏感性明显高于 MRCP 图像组（P <.0001），特异性损失最小。MRCP 后 38.0%的患者和 ERCP 后 68.1%的患者报告了不良事件。在 55 例发生严重不良事件的患者中，3 例（1.2%）和 52 例（20.5%）事件分别被认为与 MRCP 和 ERCP 有时间相关性。最常被认为与 RG1068 相关的不良事件为恶心、腹痛和潮红，大多数为轻度。
与 MRCP 图像相比，RG1068 刺激的 MRCP 在多个方面均有改善，有助于诊断和临床决策，适用于急性、复发性或慢性胰腺炎患者。RG1068 增强的 MRCP 也可能更好地识别需要治疗性 ERCP 的患者（ClinicalTrials.gov，编号：NCT00660335）。
