Pain a&er cholecystectomy Naviga4ng a clinical minefield

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Lynn Mosley
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1 Pain a&er cholecystectomy Naviga4ng a clinical minefield Peter B Co9on MD, FRCP, FRCS Professor of Medicine Diges4ve Disease Center Medical University of South Carolina 1

2 Diges4ve Disease Center Pa4ent- friendly care A springboard for the research and educa4on needed to improve it Page 2

3 The pinball patient Gastro- enterology Oncology Radiology Medicine Surgery Pathology

4 if you have only a hammer everything looks like a nail

5 Gastro- enterology Medicine Radiology Oncology Surgery Pathology

6 PuGng pa4ents first Solly Marks (sage of SAGES) Consider the whole pa4ent, not just the hole in the pa4ent

7 Cholecystectomy > 0.5 million/year in USA 10-15% unhappy a&erwards Some have pathology (eg stones, strictures, leaks) detected by labs and scans Many have no objec4ve evidence for biliary or pancrea4c disease, and dysfunc4on of the sphincter of Oddi is considered 7

8 (Adapted from Boyden, 1957, and reproduced from, Rass BD, With permission of UpToDate) 8

9 Sphincter of Oddi Dysfunc4on (SOD) Over- or in- appropriate ac4vity of the sphincter can cause pain a9acks by increasing the pressure in the biliary and/or pancrea4c ducts 9

10 Current treatment Recommended by NIH conference in 2002 ERCP (Endoscopic Retrograde CholangioPancreatography), with sphincter manometry leading to sphincterotomy of the biliary and/or pancrea4c sphincters 10

11 ERCP sphincterotomy 11

12 The problem Lots of pa4ents coming to experts at MUSC Published results are unimpressive Cohort studies claim only modest improvement One small randomized trial Manometry is unproven as a predictor Risks are substan4al Pancrea44s rate at least 15%. Perfora4ons occur Slippery slope of more procedures, even resec4ons 12

13 The EPISOD study Evalua4ng Predictors and Interven4ons in Sphincter of Oddi Dysfunc4on A mul4- center trial funded by NIDDK 13

JAMIDAR Midwest TherapeuKc Endoscopy Consultants, St.

14 EPISOD Study sites Virginia Mason Medical Center, Sea3le, KOZAREK University of Minnesota, FREEMAN Indiana University, FOGEL Yale, JAMIDAR Midwest TherapeuKc Endoscopy Consultants, St. Louis, ALIPERTI MUSC,Charleston, ROMAGNUOLO Methodist Dallas Medical Center, TARNASKY 14

15 Does sphincterotomy help? How to measure help? Pa4ents impression (PGIC) too subjec4ve Quality of life too general Change in the pain burden 15

16 Measuring pain Most pain scoring systems (eg McGill) deal with chronic daily pain (cancer), and simple intensity (VAS) is a sufficient measure Rome III consor4um defines biliary pain as episodic, not daily How to measure intermi9ent pain, and changes in it? 16

17 Measuring episodic pain Daily diaries? Problem with lead- in data, and compliance for follow- up of one to three years Retrospec4ve recall Days of pain and intensity; not validated MIDAS 17

18 MIDAS for migraine Number of days in the prior 3 months that work/ school, household and social ac4vi4es were compromised by pain. Grades 1 = <5 days; 2 = 6-12 days; 3 = days; 4 = >20 days Validated by test- retest and against 90 day diaries Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and tes4ng of the Migraine Disability Assessment (MIDAS) Ques4onnaire to assess headache- related disability. Neurology 2001; 56: S20- S28Stewart WF et al. 18

19 RAPID Recurrent Abdominal Pain Interference and Disability Number of days in the prior 3 months that work/school, household and social ac4vi4es were compromised by pain Maximum score 270 Also, number of days pain and average severity Pilot studies showing Good test- retest correla4on 80% grade 3 or 4 before treatment, and 65% grade1 a&er treatment Valerie Durkalski, Walter Stewart, Paule9e MacDougall, Patrick Mauldin, Joseph Romagnuolo, Olga Brawman- Minzter, Peter Co9on. Measuring episodic abdominal pain and disability in suspected sphincter of Oddi dysfunc4on. World J Gastroenterol 2010 September 21; 16(35):

20 1. On how many days in the last 3 months did you miss work or school because of your episodes of abdominal pain? days 2. On how many days in the last 3 months was your produc4vity in work or school reduced by half or more because of your episodes of abdominal pain (Do not include days you counted in ques4on 1 where you missed work or school.)? days 3. On how many days in the last 3 months did you not do household work because of your episodes of abdominal pain? days 4. On how many days in the last 3 months was your produc4vity in household work reduced by half or more because of your episodes of abdominal pain (Do not include days you counted in ques4on 1 where you did not do household work.)? days 5. On how many days in the last 3 months did you miss family, social or leisure ac4vi4es because of your episodes of abdominal pain? days 6. On how many days in the last 3 months did you have episodes of abdominal pain (If the abdominal pain lasted more than 1 day, count each day.)? days 7. On a scale of 0-10, on average, how painful were these episodes 20

21 EPISOD Current Status Completed enrollment March randomized - 72 enrolled in observa4onal study Last subject completed 12- month follow up March 2013 Execu4ve Commi9ee Unblinded Aug

22 Overall RAPID Data EPISOD Baseline Rapid (3- mo recall) Median RAPID Score: 74days of disability Ave intensity of pain episodes (10- pt scale): 7 EPISOD Mo12 Change from Baseline Median Change in RAPID Score: 44day decrease 22

23 Ques4ons on the RAPID Accuracy of 90 day recall? Do pa4ents exaggerate to gain entry/sympathy? And maybe minimize a&er treatment? Are they at peak burden at entry? 23

24 EPISOD study The results of the sham- controlled study will be announced shortly And will have a big impact on prac4ce in this minefield 24

Sphincter of Oddi dysfunction: SOD after EPISOD, Now what do we do?

Sphincter of Oddi dysfunction: SOD after EPISOD, Now what do we do? Priya A. Jamidar, M.D., FASGE Professor of Medicine, Director of Endoscopy Yale School Y A L E S CH OO L O F MEDIC IN E February in Connecticut