Internal Clinical Guidelines Team Document information (i.e. version number etc) Gallstone disease Diagnosis and management of cholelithiasis, cholecystitis and choledocholithiasis Clinical Guideline <…> Methods, evidence and recommendations 2014 Draft for Consultation National Institute for Health and Care Excellence Disclaimer Healthcare professionals are expected to take NICE clinical guidelines fully into account when exercising their clinical judgement. However, the guidance does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of each patient, in consultation with the patient and/or their guardian or carer. Copyright National Institute for Health and Care Excellence, Date xxxx. All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes within the NHS. No reproduction by or for commercial organisations is allowed without the express written permission of the National Institute for Health and Care Excellence. Gallstone disease Contents Contents 1 Overview .................................................................................................................................. 7 Patient-centred care ................................................................................................................ 7 2 Summary Section .................................................................................................................. 9 Guideline development group (GDG) members.................................................................... 9 Internal clinical guidelines team.............................................................................................. 9 Centre for Clinical Practice commissioning team................................................................ 10 Key priorities for implementation .......................................................................................... 11 Algorithm................................................................................................................................. 12 List of all recommendations .................................................................................................. 13 Research recommendations ................................................................................................. 14 Strength of recommendations............................................................................................... 15 3 Methods ................................................................................................................................. 16 3.1 Additional methods used in this guideline .................................................................. 16 3.1.1 Methods for combining diagnostic evidence: ................................................ 16 3.1.2 Methods for combining direct and indirect evidence (network meta- analysis)............................................................................................................ 16 3.1.3 References ....................................................................................................... 19 4 Evidence Review and Recommendations....................................................................... 20 4.1 Signs, symptoms and risk factors for gallstone disease ........................................... 20 4.1.1 Review Question 1........................................................................................... 20 4.1.2 Evidence Review ............................................................................................. 20 4.1.3 Health economic evidence .............................................................................. 21 4.1.4 Evidence Statements ...................................................................................... 21 4.1.5 Evidence to Recommendations ...................................................................... 21 4.1.6 Recommendations ........................................................................................... 22 4.1.7 Research recommendations ........................................................................... 23 4.1.8 References ....................................................................................................... 23 4.2 Diagnosing gallstone disease ..................................................................................... 29 4.2.1 Review Question 2........................................................................................... 29 4.2.2 Evidence Review ............................................................................................. 29 4.2.3 Health economic evidence .............................................................................. 34 4.2.4 Evidence Statements ...................................................................................... 37 4.2.5 Evidence to Recommendations ...................................................................... 37 4.2.6 Recommendations ........................................................................................... 42 4.2.7 Research recommendations ........................................................................... 42 4.2.8 References ....................................................................................................... 42 4.3 Asymptomatic gallbladder stones ............................................................................... 45 4.3.1 Review Question 3........................................................................................... 45 Internal Clinical Guidelines, 2014 4 Gallstone disease Contents 4.3.2 Evidence Review ............................................................................................. 45 4.3.3 Health economic evidence .............................................................................. 46 4.3.4 Evidence Statements ...................................................................................... 46 4.3.5 Evidence to Recommendations ...................................................................... 47 4.3.6 Recommendations & Research Recommendations ..................................... 48 4.3.7 References ....................................................................................................... 48 4.4 Managing asymptomatic gallbladder stones ............................................................. 49 4.4.1 Review Question 4a ........................................................................................ 49 4.4.2 Evidence Review ............................................................................................. 49 4.4.3 Health economic evidence .............................................................................. 49 4.4.4 Evidence Statements ...................................................................................... 49 4.4.5 Evidence to Recommendations ...................................................................... 49 4.4.6 Recommendations ........................................................................................... 51 4.4.7 Research Recommendations ......................................................................... 51 4.4.8 References ....................................................................................................... 52 4.5 Managing symptomatic gallbladder stones................................................................ 53 4.5.1 Review Question 4b ........................................................................................ 53 4.5.2 Evidence Review ............................................................................................. 53 4.5.3 Health economic evidence .............................................................................. 56 4.5.4 Evidence Statements ...................................................................................... 59 4.5.5 Evidence to Recommendations ...................................................................... 59 4.5.6 Recommendations ........................................................................................... 63 4.5.7 Research recommendations ........................................................................... 64 4.5.8 References ....................................................................................................... 64 4.6 Managing common bile duct stones ........................................................................... 66 4.6.1 Review Question 4c......................................................................................... 66 4.6.2 Evidence Review ............................................................................................. 66 4.6.3 Health economic evidence .............................................................................. 74 4.6.4 Evidence Statements ...................................................................................... 77 4.6.5 Evidence to Recommendations ...................................................................... 78 4.6.6 Recommendations ........................................................................................... 82 4.6.7 Research recommendations ........................................................................... 83 4.6.8 References ....................................................................................................... 83 4.7 Timing of laparoscopic cholecystectomy ................................................................... 86 4.7.1 Review Question 5..........................................................................................