Evidencebased guidelines for diagnosis of common bile duct stones Vanja Giljaca University Hospital Center Rijeka Department of Gastroenterology Trusted evidence. Informed decisions. Better health.
Outline 01 What are CPGs and how they are made. 02 Specifics of diagnostic CPGs. 03 Common bile duct stones overview. 04 Current recommendations for CBDs diagnosis. 05 Cochrane diagnostic test accuracy systematic review for diagnosis of CBDs. 06 What next?
Clinical Practice Guidelines (CPGs) Statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options. Committee on Standards for Developing Trustworthy CPGs, Institute of Medicine, 2011
When did guidelines first appear?
Ancient Medicine, Israel Ayurveda Razi Book of Medicine, Iran Asclepius, Greece
The EVIDENCE difference?
Systematic reviews Randomised controlled studies Cohort studies Case reports Expert opinion Sackett DL, Straus SE, Richardson WS, i sur. Evidencebased medicine: how to practice and teach EBM. 2nd ed., Churchill Livingstone, 2000.
Do we need CPGs?
PubMed ((((common bile duct stones) OR choledocholithiasis) OR CBD stones) AND diagnostic accuracy) OR diagnostic test accuracy; 12482 citations Publication date from 2014/01/01 to 2014/12/31 434 citations
Clinical Expertise Patient Concerns/Welfare Best research evidence
Clinical Expertise Patient Concerns/Welfare Best research evidence
Who can use CPGs? Physicians/Nurses Patients Families Decision makers Public EFFECTIVE HEALTHCARE SAVES LIVES......AND MONEY
OUTCOMES POSITIVE INCONCLUSIVE NEGATIVE CPGs for diagnostic tests Suspicion Condition 1 DIAGNOSTIC TEST ACCURACY Diagnosis Intervention Condition 2 Condition 3 Test 1 Test 2 Condition 1 Drug Condition 4 Condition 5 Test 3 Test 4 Condition 6 Surgery Condition 6
Sensitivity = TP / TPFN Specificity = TN / TNFP TPtrue positive; FPfalse positive; FNfalse negative; TNtrue negative
Or air? Stone or Tumor??? Or bowel wall? Or diverticulum? Or sludge? Or nothing?
2% to 4% of population has common bile duct stones (CBDS) Sarli L, et al. Asymptomatic bile duct stones: selection criteria for intravenous cholangiography and/or ERCP prior to laparoscopic cholecystectomy. European Journal of Gastroenterology & Hepatology 2000;12:117580.
Common bile duct stones (CBDS) 90% 10 % Symptomatic Asymptomatic Williams EJ, et al. Guidelines on the management of common bile duct stones. Gut 2008;57:100421. Sarli L, et al. Asymptomatic bile duct stones: selection criteria for intravenous cholangiography and/or ERCP prior to laparoscopic cholecystectomy. European Journal of Gastroenterology & Hepatology 2000;12:117580.
Symptomatic CBDS x10 % 12 10 8 90% 70% 10 % Pain Jaundice 6 Acute cholangitis 4 2 9% 9% Acute pancreatitis 0 2 0 1 2 3 4 5 Williams EJ, et al. Guidelines on the management of common bile duct stones. Gut 2008;57:100421. Sarli L, et al. Asymptomatic bile duct stones: selection criteria for intravenous cholangiography and/or ERCP prior to laparoscopic cholecystectomy. European Journal of Gastroenterology & Hepatology 2000;12:117580.
Mortality 10% Williams EJ, et al. Guidelines on the management of common bile duct stones. Gut 2008;57:100421. Sarli L, et al. Asymptomatic bile duct stones: selection criteria for intravenous cholangiography and/or ERCP prior to laparoscopic cholecystectomy. European Journal of Gastroenterology & Hepatology 2000;12:117580.
Current diagnostic pathway Symptoms & signs (pain, jaundice, cholangitis, pancreatitis) 1. LFTs US Sens. 90% Spec. 30% 2. MRCP EUS Sens. 99% Spec. 97% 3. ERCP IOC Dx.??? Therapy Williams EJ, et al. Guidelines on the management of common bile duct stones. Gut 2008;57:100421. LFTs: liver function tests US: abdominal ultrasound MRCP: magnetic resonance cholangiopancreatography EUS: endoscopic ultrasound ERCP: endoscopic retrograde cholangiopancreatography IOC: intraoperative cholangiography
CBDS after laparoscopic cholecystectomy: 3% 5% 30% 50% < IOC False IOC False preop. & postop. workup Spontaneous evacuation Collins C, Maguire D, Ireland A, Fitzgerald E, O'Sullivan GC. A prospective study of common bile duct calculi in patients undergoing laparoscopic cholecystectomy. Ann Surg 2004;239(1):2833.
Which diagnostic test to choose? No clear recommendations Freitas 2006, Duca S, Bala O, AlHajjar N, Iancu C, Puis IC, Munteanu D, Graur F. Laparoscopic cholecystectomy: incidents and complications. A retrospective analysis of 9542 consecutive laparoscopic operations. HPB 2003;5(3):1528. Maple JT, BenMenachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, i sur. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc 2010;71(1):19.
A comprehensive systematic review and metaanalysis of all modern diagnostic tests for CBDS does not exist Guidelines are based on clinical experience, primary studies or comparative head to head metaanalyses
Aims 2 1 3 Comparison 1. step 2. step 3. step LFTs US EUS MRCP ERCP Diagnostic IOC accuracy E R C P Diagnostic algorithm EUS I O C LFTs US MRCP E R C P I O C
Diagnostic accuracy Ref. standard POS Index test POS TP FP Index test NEG FN TN Ref. standard NEG Sensitivity = TP / TPFN Specificity = TN / TNFP TPtrue positive; FPfalse positive; FNfalse negative; TNtrue negative; PPVpositive predictive value; NPVnegative predictive value
Diagnostic accuracy ROC curve ROC curve Summary sensitivity and specificity point 95% confidence region
Literature search 22790 16923 518 36 5867 Duplicates 1 5 16405 Not relevant 13 482 Incl. criteria not met 7 5 5 LFTs US EUS MRCP ERCP IOC
Sensitivity LFTs vs US Not statistically different Specificity US Bilirubin >2x upper limit Alkaline phosphatase >2x upper limit
Sensitivity EUS vs MRCP p = 0,686 Specificity MRCP EUS
Sensitivity ERCP vs IOC p = 0,494 IOC Specificity
Posttest probability Diagnostic accuracy post test probability Clinically more useful measure of diagnostic accuracy Prevalencedependent Pre test probability PREVALENCE
Posttest probabilities summary Post test probability for positive test Post test probability for negative test LFTs 91,5% 30,5% US EUS MRCP ERCP IOC 84,5% 17,2% 96,0% 3,6% 93,9% 4,9% 99,0% 7,4% 98,0% 1,1%
Suspected CBDS No cholecystectomy Postcholecystect. LFT/ US LFT/ US EUS ERCP ES/ Ex Kcx Kcx/ IOC? IOC Fup Surg. expl. Kcx/ Fup Simpt. Fup / other pathology MRCP Fup / other pathology ERCP Fup / other pathology ES/Ex Fup Diagnostic pathway
Diagnostic pathway Suspected CBDS No cholecystectomy Postcholecystect. Screening??? LFT/ US LFT/ US ES/ Ex ERCP EUS Kcx/ IOC? IOC Kcx/ Fup Simpt. MRCP ERCP Fup / other pathology Kcx Surg. expl. Fup ES/Ex Fup / other pathology Fup Fup / other pathology
Suspected CBDS No cholecystectomy Postcholecystect. LFT/ US LFT/ US EUS ERCP ES/ Ex Kcx Kcx/ IOC? IOC Fup Surg. expl. Kcx/ Fup Simpt. Fup / other pathology MRCP Fup / other pathology ERCP Fup / other pathology ES/Ex Fup Diagnostic pathway
What next? British Society of Gastroenterology plans to implement our results in new guidelines
What next?
Thank you! Split