BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- To assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT).
研究概览
简要总结
13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.
详细描述
The aim of the study is to assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT). Furthermore, a second purpose is to assess the ability to differentiate between non patients with chronic pancreatitis and those without. Approximately 30 subjects will be tested with both methods within two weeks of each other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with chronic pancreatitis who meet at least one of the following criteria:
- •Adult men or women >18 years of age.
- •Endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
- •Abnormal secretin pancreatic function test with a peak bicarbonate concentration <80 mEq/L
- •Presence of pathogenomic pancreatic calcifications
- •Pathology proven chronic pancreatitis on surgical specimens
- •Females of childbearing potential must be willing to use birth control (IUD, oral, transdermal, parenteral contraceptives, or abstinence)
- •Patients who can fast for at least 8 hours
- •Able to perform the testing and procedures required for the study, as judged by the investigator
- •Willing and able to provide written informed consent
排除标准
- •Failure to obtain consent
- •Patients with liver cirrhosis
- •Any co-morbid condition with expected survival < 1 year
- •History of extensive bowel resection, multiple abdominal surgeries
- •Women who are pregnant, breastfeeding, or of childbearing potential and not willing to use methods of birth control
- •Uncontrolled diabetes
- •Patients currently receiving total parenteral nutrition (TPN)
- •Recipients of an organ transplant
- •Patients who have consumed >20cc of alcohol or have taken acetaminophen in the past 24 hours
- •History of chronic obstructive pulmonary disease or symptomatic bronchial asthma
- •Patients taking drugs that can interfere with 13C di-peptide metabolization
研究组 & 干预措施
Di -petide breath tests and ePFT secretin induced
Di peptide breath tests will be performed on subjects with known chronic pancreatitis
干预措施: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) (Drug)
c13 di peptide breath tests
Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis
干预措施: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) (Drug)
结局指标
主要结局
To assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT).
时间窗: 1 hour
This breath test substrate is new and is hypothesized, based on preliminary studies, that it may be the answer to a much needed non-invasive pancreatic function test. At first stage, it will be compared to the current invasive gold standard: secretin induced ePFT.
次要结局
- To assess the ability to differentiate between non patients with chronic pancreatitis and those without.(1 hour)