Novel Breath Test To Detect Early Stage Chronic Pancreatitis

描述(申请人提供)：胰腺疾病影响这个国家的100多万人，医疗费用近30亿美元。慢性胰腺炎(CP)的发病率正在迅速上升，可能与过度饮酒有关。晚期CP会对胰腺造成严重的结构性损害，导致慢性腹痛、内分泌衰竭(糖尿病)和外分泌衰竭(脂肪吸收不良)。通过CT扫描、内窥镜逆行胰胆管造影术和内窥镜超声等成像技术，可以很容易地发现晚期CP。然而，轻到中度的CP对临床医生来说是一个更困难的挑战。影像技术在约40%的时间内无法识别较低程度的CP病例。一种更灵敏的检测轻中度CP的方法是分泌素刺激试验。但这项测试是有创的，需要患者吞下放置在十二指肠内的肠管，并在透视检查下进行检查。分泌素刺激测试只在美国的几个中心进行，使患者暴露在辐射中，需要放置导管并收集胰腺分泌物，而不使用镇静剂一小时，这会导致患者不适。我们开发了一种新的、非侵入性、非放射性的13C呼气测试，名为胰腺呼气测试(PBT)。这种呼气测试使用示踪剂量的13C-碳酸氢钠来检测胰泌素刺激胰腺后释放的碳酸氢钠的量。一个正常的胰腺会在刺激下释放未标记的碳酸氢盐，降低呼出的二氧化碳的13C/12C的比率。预计慢性胰腺炎患者呼出的二氧化碳13C/12C的比率会有较小的变化。我们根据分泌素刺激试验的基本原理开发了这项测试，该测试可以检测碳酸氢盐外分泌功能的早期变化。对25名轻中度CP患者和25名健康对照进行病例对照研究，以显示新呼气测试的可行性。我们的假设是，测量胰腺释放的碳酸氢盐的损失将有助于发现早期CP。这种早期准确的诊断将提高生活质量，减少昂贵和侵入性手术的数量，从而降低医疗保健成本。CP患者的有效治疗始于可靠的诊断。早期发现CP，胰酶治疗可改善轻中度CP的远期预后。由于呼气测试目前是许多参考实验室的常规程序，PBT可以被用作一种相对便宜(100美元)的发送测试，可以在当地卫生中心进行。 公共卫生相关性：早期慢性胰腺炎的诊断是胃肠病学最大的挑战之一。我们将开发一种低成本、高灵敏度的非侵入性呼气试验来检测早期慢性胰腺炎。最终结果是改善了护理质量，并总体上降低了与识别慢性胰腺疾病相关的医疗成本。

DESCRIPTION (provided by applicant): Disorders of the pancreas affect more than one million persons in this country with nearly $3 billion in health care costs. The incidence rate of chronic pancreatitis (CP) is rapidly increasing and may be related to expanded alcohol abuse. Advanced CP causes severe structural damage to the pancreas leading to chronic abdominal pain, endocrine failure (diabetes mellitus) and exocrine failure (fat malabsorption). Advanced CP can be easily detected by imaging techniques such as CT scans, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound. However, mild to moderate CP presents a more difficult challenge for the clinician. Imaging techniques fail to recognize less advanced CP cases about 40% of the time. A more sensitive test to detect mild to moderate CP is the secretin stimulation test. But this test is invasive requiring a patient to swallow an intestinal tube which is placed in the duodenum and checked under fluoroscopic evaluation. The secretin stimulation test is only done in a few US centers, exposes the patient to radiation, and requires tube placement and collection of pancreatic secretions without sedation for one hour which causes patient discomfort. We have developed a new, non-invasive, non-radioactive 13C breath test named the Pancreatic Breath Test (PBT). This breath test uses a tracer dose of sodium 13C-bicarbonate to detect the amount of bicarbonate released after stimulation of the pancreas by secretin. A normal pancreas will release unlabeled bicarbonate upon stimulation, decreasing the ratio of 13C/12C of exhaled carbon dioxide. Smaller changes in the ratio of 13C/12C of exhaled carbon dioxide are expected with chronic pancreatitis. We developed the test based on the basic principle of the secretin stimulation test which detects early changes in bicarbonate exocrine function. A case-control study in 25 mild to moderate CP patients and 25 healthy controls will be utilized to show feasibility of the new breath test. It is our hypothesis that measuring the loss of bicarbonate released by the pancreas will be beneficial to detecting early stage CP. Such an accurate diagnosis early on will lead to an improved quality of life and a decreased number of expensive and invasive procedures resulting in decreased health care costs. Effective treatment of a CP patient begins with a reliable diagnosis. The long-term outlook of mild to moderate CP can be improved with pancreatic enzyme therapy when CP is detected at an early stage. Since breath testing is currently a routine procedure in many reference laboratories, the PBT can be utilized as a relatively cheap ($100) send-out test which could be administered at local health centers. PUBLIC HEALTH RELEVANCE: Diagnosis of early-stage chronic pancreatitis is one of the greatest challenges in gastroenterology. We will develop a non-invasive breath test that is low-cost with high sensitivity for detecting early-stage chronic pancreatitis. The net result is an improvement in the quality of care and an overall reduction in health care costs associated with identifying chronic pancreatic disease.