Development of a Breath Test for Monitoring Patients With Liver Disease

Summary

The purpose of this study is to determine the safety and efficacy of the Oridion Breath ID machine in monitoring liver metabolic functions.

Timeline

Start

2005-09

Primary completion

2007-04

Completion

2007-04

Publications

• Background Ludwig J, Dickson ER, McDonald GS. Staging of chronic nonsuppurative destructive cholangitis (syndrome of primary biliary cirrhosis). Virchows Arch A Pathol Anat Histol. 1978 Aug 22;379(2):103-12. doi: 10.1007/BF00432479. No abstract available.
• Background Ludwig J, Barham SS, LaRusso NF, Elveback LR, Wiesner RH, McCall JT. Morphologic features of chronic hepatitis associated with primary sclerosing cholangitis and chronic ulcerative colitis. Hepatology. 1981 Nov-Dec;1(6):632-40. doi: 10.1002/hep.1840010612.
• Background Richard S, Guerret S, Gerard F, Tebib JG, Vignon E. Hepatic fibrosis in rheumatoid arthritis patients treated with methotrexate: application of a new semi-quantitative scoring system. Rheumatology (Oxford). 2000 Jan;39(1):50-4. doi: 10.1093/rheumatology/39.1.50.
• Background Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701.
• Background Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, Kiernan TW, Wollman J. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology. 1981 Sep-Oct;1(5):431-5. doi: 10.1002/hep.1840010511.
• Background Ishak KG. Pathologic features of chronic hepatitis. A review and update. Am J Clin Pathol. 2000 Jan;113(1):40-55. doi: 10.1309/42D6-W7PL-FX0A-LBXF.
• Background Scheuer PJ, Ashrafzadeh P, Sherlock S, Brown D, Dusheiko GM. The pathology of hepatitis C. Hepatology. 1992 Apr;15(4):567-71. doi: 10.1002/hep.1840150402.
• Background Bedossa P, Poynard T. An algorithm for the grading of activity in chronic hepatitis C. The METAVIR Cooperative Study Group. Hepatology. 1996 Aug;24(2):289-93. doi: 10.1002/hep.510240201.
• Background McGill DB, Rakela J, Zinsmeister AR, Ott BJ. A 21-year experience with major hemorrhage after percutaneous liver biopsy. Gastroenterology. 1990 Nov;99(5):1396-400. doi: 10.1016/0016-5085(90)91167-5.
• Background Perrault J, McGill DB, Ott BJ, Taylor WF. Liver biopsy: complications in 1000 inpatients and outpatients. Gastroenterology. 1978 Jan;74(1):103-6.
• Background Janes CH, Lindor KD. Outcome of patients hospitalized for complications after outpatient liver biopsy. Ann Intern Med. 1993 Jan 15;118(2):96-8. doi: 10.7326/0003-4819-118-2-199301150-00003.
• Background Ratziu V, Charlotte F, Heurtier A, Gombert S, Giral P, Bruckert E, Grimaldi A, Capron F, Poynard T; LIDO Study Group. Sampling variability of liver biopsy in nonalcoholic fatty liver disease. Gastroenterology. 2005 Jun;128(7):1898-906. doi: 10.1053/j.gastro.2005.03.084.
• Background Fontana RJ, Lok AS. Noninvasive monitoring of patients with chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S57-64. doi: 10.1053/jhep.2002.36800.
• Background Soloway RD, Baggenstoss AH, Schoenfield LJ, Summerskill WH. Observer error and sampling variability tested in evaluation of hepatitis and cirrhosis by liver biopsy. Am J Dig Dis. 1971 Dec;16(12):1082-6. doi: 10.1007/BF02235164. No abstract available.
• Background Regev A, Berho M, Jeffers LJ, Milikowski C, Molina EG, Pyrsopoulos NT, Feng ZZ, Reddy KR, Schiff ER. Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. 2002 Oct;97(10):2614-8. doi: 10.1111/j.1572-0241.2002.06038.x.
• Background Poynard T, McHutchison J, Manns M, Myers RP, Albrecht J. Biochemical surrogate markers of liver fibrosis and activity in a randomized trial of peginterferon alfa-2b and ribavirin. Hepatology. 2003 Aug;38(2):481-92. doi: 10.1053/jhep.2003.50319.
• Background Rosenberg WM, Voelker M, Thiel R, Becka M, Burt A, Schuppan D, Hubscher S, Roskams T, Pinzani M, Arthur MJ; European Liver Fibrosis Group. Serum markers detect the presence of liver fibrosis: a cohort study. Gastroenterology. 2004 Dec;127(6):1704-13. doi: 10.1053/j.gastro.2004.08.052.
• Background Poynard T, Imbert-Bismut F, Munteanu M, Messous D, Myers RP, Thabut D, Ratziu V, Mercadier A, Benhamou Y, Hainque B. Overview of the diagnostic value of biochemical markers of liver fibrosis (FibroTest, HCV FibroSure) and necrosis (ActiTest) in patients with chronic hepatitis C. Comp Hepatol. 2004 Sep 23;3(1):8. doi: 10.1186/1476-5926-3-8.
• Background Burra P, Masier A. Dynamic tests to study liver function. Eur Rev Med Pharmacol Sci. 2004 Jan-Feb;8(1):19-21.
• Background Gadano A, Hadengue A, Vachiery F, Moreau R, Sogni P, Soupison T, Yang S, Cailmail S, Lebrec D. Relationship between hepatic blood flow, liver tests, haemodynamic values and clinical characteristics in patients with chronic liver disease. J Gastroenterol Hepatol. 1997 Feb;12(2):167-71. doi: 10.1111/j.1440-1746.1997.tb00401.x.
• Background Bergstrom M, Soderman C, Eriksson LS. A simplified method to determine galactose elimination capacity in patients with liver disease. Scand J Clin Lab Invest. 1993 Nov;53(7):667-70. doi: 10.3109/00365519309092569.
• Background Merkel C, Gatta A, Zoli M, Bolognesi M, Angeli P, Iervese T, Marchesini G, Ruol A. Prognostic value of galactose elimination capacity, aminopyrine breath test, and ICG clearance in patients with cirrhosis. Comparison with the Pugh score. Dig Dis Sci. 1991 Sep;36(9):1197-203. doi: 10.1007/BF01307508.
• Background Jodynis-Liebert J, Flieger J, Matuszewska A, Juszczyk J. Serum metabolite/caffeine ratios as a test for liver function. J Clin Pharmacol. 2004 Apr;44(4):338-47. doi: 10.1177/0091270004263468.
• Background Munoz AE, Miguez C, Rubio M, Bartellini M, Levi D, Podesta A, Niselman V, Terg R. Lidocaine and monoethylglycinexylidide serum determinations to analyze liver function of cirrhotic patients after oral administration. Dig Dis Sci. 1999 Apr;44(4):789-95. doi: 10.1023/a:1026630313038.
• Background Lara Baruque S, Razquin M, Jimenez I, Vazquez A, Gisbert JP, Pajares JM. 13C-phenylalanine and 13C-methacetin breath test to evaluate functional capacity of hepatocyte in chronic liver disease. Dig Liver Dis. 2000 Apr;32(3):226-32. doi: 10.1016/s1590-8658(00)80825-7.
• Background Festi D, Capodicasa S, Sandri L, Colaiocco-Ferrante L, Staniscia T, Vitacolonna E, Vestito A, Simoni P, Mazzella G, Portincasa P, Roda E, Colecchia A. Measurement of hepatic functional mass by means of 13C-methacetin and 13C-phenylalanine breath tests in chronic liver disease: comparison with Child-Pugh score and serum bile acid levels. World J Gastroenterol. 2005 Jan 7;11(1):142-8. doi: 10.3748/wjg.v11.i1.142.
• Background Matsumoto K, Suehiro M, Iio M, Kawabe T, Shiratori Y, Okano K, Sugimoto T. [13C]methacetin breath test for evaluation of liver damage. Dig Dis Sci. 1987 Apr;32(4):344-8. doi: 10.1007/BF01296285.
• Background Shiffman ML, Luketic VA, Sanyal AJ, Duckworth PF, Purdum PP 3rd, Contos MJ, Mills AS, Edinboro LE, Poklis A. Hepatic lidocaine metabolism and liver histology in patients with chronic hepatitis and cirrhosis. Hepatology. 1994 Apr;19(4):933-40.
• Background Shiffman ML, Fisher RA, Sanyal AJ, Edinboro LE, Luketic VA, Purdum PP 3rd, Raymond P, Posner MP. Hepatic lidocaine metabolism and complications of cirrhosis. Implications for assessing patient priority for hepatic transplantation. Transplantation. 1993 Apr;55(4):830-5. doi: 10.1097/00007890-199304000-00028.
• Background Adamek RJ, Goetze O, Boedeker C, Pfaffenbach B, Luypaerts A, Geypens B. 13C-methacetin breath test: isotope-selective nondispersive infrared spectrometry in comparison to isotope ratio mass spectrometry in volunteers and patients with liver cirrhosis. Z Gastroenterol. 1999 Dec;37(12):1139-43.
• Background Klatt S, Taut C, Mayer D, Adler G, Beckh K. Evaluation of the 13C-methacetin breath test for quantitative liver function testing. Z Gastroenterol. 1997 Aug;35(8):609-14.
• Background Myers J, Ahnve S, Froelicher V, Livingston M, Jensen D, Abramson I, Sullivan M, Mortara D. A randomized trail of the effects of 1 year of exercise training on computer-measured ST segment displacement in patients with coronary artery disease. J Am Coll Cardiol. 1984 Dec;4(6):1094-102. doi: 10.1016/s0735-1097(84)80127-8.
• Background Petrolati A, Festi D, De Berardinis G, Colaiocco-Ferrante L, Di Paolo D, Tisone G, Angelico M. 13C-methacetin breath test for monitoring hepatic function in cirrhotic patients before and after liver transplantation. Aliment Pharmacol Ther. 2003 Oct 15;18(8):785-90. doi: 10.1046/j.1365-2036.2003.01752.x.
• Background Ciccocioppo R, Candelli M, Di Francesco D, Ciocca F, Taglieri G, Armuzzi A, Gasbarrini G, Gasbarrini A. Study of liver function in healthy elderly subjects using the 13C-methacetin breath test. Aliment Pharmacol Ther. 2003 Jan;17(2):271-7. doi: 10.1046/j.1365-2036.2003.01413.x.
• Background Krumbiegel P, Gunther K, Faust H, Mobius G, Hirschberg K, Schneider G. Nuclear medicine liver function tests for pregnant women and children. 1. Breath tests with 14C-methacetin and 13C-methacetin. Eur J Nucl Med. 1985;10(3-4):129-33. doi: 10.1007/BF00252720.
• Background Krumbiegel P, Stolz L, Herbarth O, Braun W, Boehm G, Kausch S, Wirsing A. Is the [15N]methacetin liver function test suited to estimate environmental effects on the maturity of neonates? Cent Eur J Public Health. 1994 Jun;2(1):49-51.

Drugs

Indications