Dario Conte, M. D. Gastroenterology and Endoscopy Unit

• Dario Conte, M.D.

• Gastroenterology and Endoscopy Unit

• Fondazione IRCCS “Cà Granda”

• Ospedale Maggiore Policlinico - Milano

• Università degli Studi di Milano

• Diagnosis - The pathway of a diagnostic test from bench to bedside

• Basic Residential Course

• April 4 – 8, 2017 - Palazzo Feltrinelli

• Gargnano - Lago di Garda - Italy

• Aim: normal values definition

• Before the evaluation of the IT diagnostic

• accuracy, the phase II studies can address other

• preliminary questions

Diagnostic Case Control Study

• Diagnostic Case Control Study

• Test

• threshold

• Healthy

• volunteers

Intestinal lymphangectasia and reversible high liver stiffness

• Intestinal lymphangectasia and reversible high liver stiffness

Diagnosis of cirrhosis by transient elastography (Fibroscan): a

• Diagnosis of cirrhosis by transient elastography (Fibroscan): a

• prospective study

• TE in 711 patients with CLD of different etiology (354 with liver biopsy)

• Foucher et al. Gut 2006

• Test

• threshold

• Patients without

• disease

In the assessment of liver fibrosis an RCT compared the

• In the assessment of liver fibrosis an RCT compared the

• accuracy of two different biopsy needles (Tru cut vs

• Menghini) in the diagnosis of liver cirrhosis:

• 1.192 patients were randomized to one of the two needles

• and a significant difference in diagnostic accuracy was found

• Colombo et al. Gastroenterology 1988

Liver stiffness measurement (LSM) is an accurate test for liver cirrhosis

• Liver stiffness measurement (LSM) is an accurate test for liver cirrhosis

• Ideal study: to estimate the cumulative incidence of FN patients randomizing patients with suspected cirrhosis to LSM or liver biopsy

• Patients classified as cirrhotics should undergo endoscopy

• The comparison of the negative results could identify the safer procedure

• RCT

• Large cohorts study

• To assess in case of discordance between the IT and RS results what are the right results and

• The proportion of patients with rare adverse events from the diagnostic test-therapeutic strategy