title: Development and Diagnostic Accuracy of a Breath Test for Pancreatic Exocrine Insufficiency in Chronic Pancreatitis.
abstract: OBJECTIVE
  To develop a ¹³C-labeled substrate breath test by defining the optimal ¹³C-labeled substrate, substrate dose, test meal, and duration of the test and evaluating its accuracy for the diagnosis of pancreatic exocrine insufficiency (PEI) in chronic pancreatitis (CP).
  
  
  METHODS
  Five consecutive prospective comparative studies in patients with known advanced CP and healthy controls were performed to develop the optimal breath test. Coefficient of fat absorption was used as the reference method. The diagnostic accuracy of the optimized breath test was prospectively further evaluated in patients with advanced CP using coefficient of fat absorption as the reference method.
  
  
  RESULTS
  The optimal breath test protocol was that using 250 mg of ¹³C-mixed triglyceride as substrate together with a test meal containing 16 g of fat. Coefficient of fat absorption and breath test results correlated significantly (r = 0.736, P < 0.001). The test has sensitivity, specificity, and overall accuracy of 92.9%, 91.7%, and 92.3%, respectively, for the diagnosis of PEI.
  
  
  CONCLUSIONS
  The optimized ¹³C-mixed triglyceride breath test is an accurate and simple breath test for the diagnosis of PEI in patients with CP, easily applicable to the clinical routine.
authors.affiliation: From the *Department of Gastroenterology and Hepatology, †Health Research Institute of Santiago (IDIS), and ‡Department of Clinical Chemistry, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.
authors.forename: J Enrique
authors.initials: JE
authors.lastname: Domínguez-Muñoz
authors.forename: Laura
authors.initials: L
authors.lastname: Nieto
authors.forename: María
authors.initials: M
authors.lastname: Vilariño
authors.forename: M Victoria
authors.initials: MV
authors.lastname: Lourido
authors.forename: Julio
authors.initials: J
authors.lastname: Iglesias-García
mesh_terms: D065567:Absorption, Physiological; D000328:Adult; D001944:Breath Tests / Q000379:methods*; D002247:Carbon Isotopes / Q000008:administration & dosage / Q000493:pharmacokinetics; D010188:Exocrine Pancreatic Insufficiency / Q000150:complications / Q000175:diagnosis*; D005223:Fats / Q000008:administration & dosage / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010179:Pancreas / Q000378:metabolism / Q000473:pathology*; D050500:Pancreatitis, Chronic / Q000150:complications / Q000175:diagnosis*; D011446:Prospective Studies; D012372:ROC Curve; D015203:Reproducibility of Results; D013997:Time Factors; D014280:Triglycerides / Q000008:administration & dosage / Q000493:pharmacokinetics; D055815:Young Adult
chemical_list: D002247:Carbon Isotopes; D005223:Fats; D014280:Triglycerides