Novel Breath Test To Detect Early Stage Chronic Pancreatitis

检测早期慢性胰腺炎的新型呼吸测试

• 批准号: 8001742
• 负责人: Phillip TOSKES
• 金额: $ 10.23万
• 依托单位: METABOLIC SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8001742
• 关键词: Abdominal Pain; Affect; Alcohol abuse; Bicarbonates; Breath Tests; Carbon Dioxide; Case-Control Studies; Chronic; Collection; Complex; Country; Data; Deglutition; Detection; Diabetes Mellitus; Diagnosis; Dose; Duodenum; Early Diagnosis; Endocrine; Endoscopic Retrograde Cholangiopancreatography; Endoscopic Ultrasonography; Evaluation; Exhalation; Failure; Fatty acid glycerol esters; Fluoroscopy; Gastroenterology; Goals; Grant; Health; Health Care Costs; Healthcare; Helicobacter pylori; Histology; Hormonal; Hormones; Hour; Image; Imaging Techniques; Impairment; Incidence; Inflammatory; Intestines; Isotopes; Laboratories; Lead; Malabsorption Syndromes; Mass Spectrum Analysis; Measures; Medical History; Medical Waste; Medical center; Metabolic; Monitor; Names; Oral; Pancreas; Pancreatic Diseases; Pancreatic Function Tests; Pancreatic enzyme; Patients; Persons; Phase; Physicians' Offices; Primary Health Care; Procedures; Protocols documentation; Quality of Care; Quality of life; Radiation; Radioactive; Recovery; Research; Resources; Scanning; Secretin; Sedation procedure; Sodium; Solutions; Staging; Testing; Time; Tracer; Tube; Ultrasonography; Urea; X-Ray Computed Tomography; base; chronic abdominal pain; chronic pancreatitis; cost; effective therapy; enzyme therapy; improved; novel; pancreatic juice; prevent; public health relevance

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.

描述（由申请人提供）：胰腺疾病影响了这个国家的100多万人，医疗费用近30亿美元。慢性胰腺炎（CP）的发病率正在迅速增加，可能与扩大的酒精滥用有关。晚期CP导致胰腺严重结构损伤，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）。晚期CP可以通过成像技术如CT扫描、内窥镜逆行胰胆管造影和内窥镜超声很容易地检测到。然而，轻度至中度CP对临床医生提出了更困难的挑战。成像技术无法识别约40%的时间不太先进的CP病例。一个更敏感的测试，以检测轻度至中度CP是分泌素刺激试验。但是这种测试是侵入性的，需要患者吞下放置在十二指肠中的肠管，并在荧光镜下进行检查。促胰液素刺激试验仅在少数美国中心进行，使患者暴露于辐射，并且需要放置管并收集胰腺分泌物，而无需镇静1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13 C呼吸试验，称为胰腺呼吸试验（PBT）。该呼吸试验使用示踪剂量的13 C-碳酸氢钠来检测胰泌素刺激胰腺后释放的碳酸氢盐量。正常胰腺在刺激时会释放未标记的碳酸氢盐，降低呼出二氧化碳的13 C/12 C比率。预计慢性胰腺炎患者呼出二氧化碳的13 C/12 C比值变化较小。我们根据分泌素刺激试验的基本原理开发了该试验，该试验可检测碳酸氢盐外分泌功能的早期变化。一项在25名轻度至中度CP患者和25名健康对照中进行的病例对照研究将被用于显示新呼吸测试的可行性。我们的假设是，测量胰腺释放的碳酸氢盐的损失将有利于检测早期CP。这种早期的准确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。当CP在早期被检测到时，胰酶治疗可以改善轻中度CP的长期前景。由于呼吸测试目前是许多参考实验室的常规程序，PBT可以用作相对便宜（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吸测试，用于检测早期慢性胰腺炎。最终结果是提高了护理质量，并总体降低了与识别慢性胰腺疾病相关的医疗保健成本。