EXOCRINE PANCREATIC FUNCTION TEST 13 C-MIXED TRIGLYCERIDE BREATH TEST

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1 Institute of Clinical Biochemistry and Laboratory Diagnostics 1st Faculty of Medicine, Charles University General Faculty Hospital, Prague P.Kocna, Z.Vaničková,, T.Krechler, T M.Lukáš,, J.Doseděl, P.Kohout EXOCRINE PANCREATIC FUNCTION TEST 13 C-MIXED TRIGLYCERIDE BREATH TEST XXXVIII Meeting of EPC - Tampere - June 9, 2006

2 GOLD STANDARDS FOR EXOCRINE PANCREATIC FUNCTION FAT 72 hr. QUANTITATIVE FECAL FAT STOOL SAMPLING - 72hr. S-CCK TEST 2 WGO-OMGE OMGE Practice Guideline: Malabsorption The gold standard still is the SECRETIN-PANCREOZYMIN-TEST TEST

3 100% 80% 60% 40% 20% 0% FELA 13-BT 13C-BT FELA FCHT FAT LUNDH PLT BT-PABA SCCK 3 Boeck WG, Curr.Gastroent.Rep. 2001, 3:

4 Motto: if only we had simple, cheap and reliable test of exocrine pancreatic function... EXOCRINE PANCREATIC FUNCTION TEST WHEN - WHICH - WHY We compared laboratory and clinical aspects FECAL ELASTASE C-MIXED TRIGLYCERIDE BREATH TEST 4 Friday poster - P122 Faecal Elastase 1 Performance & Use in Diagnosis of Chronic Pancreatitis

5 DIRECT PZS TEST SECRETIN PANCREOZYMIN FECAL ELASTASE WITHOUT STIMULATION PABA, 13C-MTG STIMULATING MEAL INDIRECT STIMULATION AMYLASE LIPASE TRYPSIN BICARBONATE FECAL ELASTASE ENZYMES FROM THERAPY/DRUGS WITH mab NO REACTION LIPASE LIPASE ENZYME THERAPY LIPID HYDROLYSIS TEST, SUBSTRATE 5 DIRECT RESPONSE TO STIMULATION SECRETORY CAPACITY GRADING CHP DIGESTIVE FUNCTION OF (LIPID) DIGESTION

6 CHRONIC PANCREATITIS CLASSIFICATION BERN 2000 (Büchler, Malfertheiner) CHP A - non-complicated, mild CHP, with normal functions CHP B - clinical complications, with normal functions CHP C = clinical manifestation of functional insufficiency CHP C1 - steatorrhoea or DM CHP C2 - steatorrhoea and DM CHP C3 - steatorrhoea and/or DM + complications This study , 184 patients with susp. CHP 6 CHP group number NON A B C1/2 C age (mean) F : M 1 : 1 1 : 1 1 : 2 1 : 1 1 : 6

7 TEST PROCEDURE TWO SAMPLE BAGS AFTER FASTING STIMULATION MEAL 4 CRISP SLICES, MAIZE WITH FIBRES (WITHOUT CHOLESTEROL, GLUTEN-FREE) 2 x 10g RAMA (VEGETABLE FAT WITHOUT MILK PROTEINS) TEST SUBSTANCE ADMINISTRATION - 250mg 13 C-MTG STIRRED INTO VEGETABLE FAT HOURLY BREATH-BAG BAG SAMPLING (1-6 hr) h TEST ANALYTICS DOB MEASUREMENT OF EACH SAMPLE 13 CO 12 2 : 1 2 CO 2 v T SAMPLE x AGAINST T 0 (DOB = Delta Over Baseline) T x 13 C-MTG BREATH TEST - PROCEDURE EVALUATION OF PANCREATIC INSUFFICIENCY BSA CALCULATED (BASED ON WEIGHT, HEIGHT ONLY) BMR AND CO 2 PRODUCTION CALCULATION 7 CUMMULATIVE RECOVERY FOR 6 HOURS CALCULATION

8 13 C-MTG BREATH TEST - IR ANALYSIS 13 C/ 12 C ratio analysis NDIRS analytical al units Isomax 4000 (Canada) HeliFAN plus (Germany) 8

9 8,000 7, C-MTG BREATH TEST - KINETIC DOB VALUES 13 CO 12 2 : 1 2 CO 2 in AFTER 250mg MTG FECAL ELASTASE µg/g 6,000 NORMAL 5,000 4, ,000 2,000 1,000 0,000 PATHOLOGICAL

10 13 C-MTG BREATH TEST - RECOVERY 10 80,000 70,000 60,000 50,000 40,000 30,000 20,000 10,000 0,000 CUMMULATIVE RECOVERY 13 CO 2 in % NORMAL PATHOLOGICAL FECAL ELASTASE µg/g cut - off = 30 %

11 13 C-MTG BREATH TEST x FECAL ELASTASE cpdr MTG (%) 80,0 70,0 60,0 50,0 40,0 100 µg/g CUT-OFF FELA: : 200 µg/g NORMAL CHP-A CHP-B CHP-C1 C1 CHP-C2 C2 CHP-C3 C3 NON-CHP 30,0 20,0 10,0 ABNORMAL CUT-OFF MTG: : 30 % 184 BREATH TESTS S WITH C-MTG 62 CONTROLS (NON-CHP), 122 CHP AGREEMENT MTG & FELA 80.2 % ((142/177) 11 0, FELA µg/g

12 13 C-MTG BREATH TEST x FECAL ELASTASE BREATH TESTS 35 S WITH C-MTG 62 CONTROLS (NON-CHP), 122 CHP 40.4% DISCREPANCY, CHP-B, C NON CHP-A CHP-B CHP-C1/2 CHP-C3 12 FREQUENCY OF CASES FELA < 100 µg/g & 13 C-MTG > 30%

13 13 C-MTG BREATH TEST x FECAL ELASTASE CHRONIC PANCREATITIS GROUP B - WITH NORMAL FUNCTIONS 13.0 % LOW FELA, LOW MTG SERIOUS PANCREAS DAMAGE WHIPPLE - TUMOUR - DRAINAGE AGE 47.8 % HIGH FELA, HIGH MTG 0 % HIGH FELA, LOW MTG 39.1 % LOW FELA, HIGH MTG SERIOUS PANCREAS DAMAGE WHIPPLE - TUMOUR - DRAINAGE AGE - C3 NORMAL EXOCRINE FUNCTION BEGER 4x, NONE NE WHIPPLE, NONE TUMOUR, NO ONE TO C3 13 FREQUENCY OF CASES FELA < 100 µg/g & 13 C-MTG > 30%

14 13 C-MTG BREATH TEST x FECAL ELASTASE CHRONIC PANCREATITIS, GROUP C3 WITH CLINICAL SYMPTOMS EXOCRINE INSUFFICIENCY (DM, STTRH) + COMPLICATIONS 2.9 % HIGH FELA, LOW MTG 55.8 % LOW FELA, LOW MTG DRAINAGE INTERVENTION TION 8/19 = 42.15% 38.2 % LOW FELA, HIGH MTG DRAINAGE AGE INTERVENTION TION 3/13 = 23.1% 2.9 % HIGH FELA, HIGH MTG 14 FREQUENCY OF CASES FELA < 100 µg/g & 13 C-MTG > 30%

15 EXOCRINE PANCREATIC FUNCTION Conclusions: : study comparing 184 subjects with susp. sp. CHP Cut-off value of cpdr 13 C-MTG test calculated by mathematical approximation, and from the control group of 62 NON-CHP subjects is equivalent - 30% 13 C-MTG test value, in CHP-A/B, classified as clinicaly normal function, was normal/high in 60 from 64 (94%), while FELA was normal/high only in 45 (70%) Agreement of FELA and 13 C-MTG in NON-CHP was 90.2%, as well as in CHP-A/C1/C2 (without complications) % Discrepancy of FELA and 13 C-MTG in 40.4% was found in groups CHP-B/C3 with complications. The combination of both tests, FELA and 13 C-MTG, we suggest in evaluation of exocrine pancreatic function. 15

16 (post)motto: simple, cheap and reliable test of exocrine pancreatic function we have not, THANK YOU however both FECAL ELASTASE-1 ASE-1 & 13 C-MTG BREATH TEST are clinically efficient in combination

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