Diagnosis and management of SOD - American...

Robert H. Hawes, MD, FACG

Robert H. Hawes, M.D.

Diagnosis and management of SOD

Center for Interventional EndoscopyProfessor of Medicine

University of Central Florida College of MedicineMedical Director

Florida Hospital Institute for Minimally Invasive Therapy

ACG/FGS Spring SymposiumMarch 28-30, 2014

Hyatt Regency Coconut PointBonita Springs, Florida

Florida Hospital Institute for Minimally Invasive Therapy

Issues to consider Spectrum of type III patients

Pure SOD Minimal SOD

Placebo effect

Selection of patients

Realistic goal of treatment Alleviation of all symptoms is unrealistic

ACG/FGS Spring Symposium - Bonita Springs, FL Copyright 2014 American College of Gastroenterology

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Rome Criteria Irritable bowel disease12/52 wks of abdominal pain + 2/3

relieved with defacation relieved with defacation

onset associated w/ change in freq of stool

onset associated w/ change in form

Sphincter of Oddi dysfunction

Severe pain in epigastrium and/or RUQ

lasts > 30 min

symptoms > 1 in last 12 mo

pain is steady & interrupts daily activity

no evidence of structural abnormalities

Clinical evaluation of patients for SOD

Take and careful historyy

R/O other more common causes of UGI pain

– include empiric medical trials

Abdominal ultrasound

obtain liver tests/pancreatic tests during or

soon after pain episode


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Stepwise assessment in patients with suspected SOD

Geenen-Hogan Classification

CLASSIC PAIN

ABNORMAL LABS

Type III

Type II Type Ior

DUCT DILATIONor

STRUCTURAL/FUNCTIONAL TESTS FOR SOD

Ultrasound +/- fatty meal or CCK

Scintigraphy +/- CCK

MRCP +/- secretin or CCK

EUS +/ secretin

= SOM EUS +/- secretin

Nardi test


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Cook Endoscopy SOM catheter

Spincter of Oddi Manometry


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SOM Video

Hogan-Geenen Biliary SOD Classification System - Frequency of Abnormal SOM and Pain Relief by Biliary Sphincterotomy

Patient group classification

Approximate frequency of

abnormal hi t

Probability of pain relief by sphincterotomy if

manometry:

Manometrybefore

sphincter bl tisphincter

manometryablation

Abnormal Normal

Biliary Type I 75-95% 90-95% 90-95% Unnecessary

Biliary Type II 55-65% 85% 35% Highly recommendedrecommended

Biliary Type III 25-60% 55-65% <10% Mandatory


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BILIARY TYPE II SOD4 YEAR F/U (N=47)

BSOP < 40mm Hg BSOP > 40 mm Hg

100%

80%

60%

40%3

3 7 311

16

g g

POOR

FAIR

GOOD

20%

0%

3

2

16

SHAM ES SHAM ES

Geenen et al N Engl J Med 1989

2211

Manometry Bases Trial of Sphxfor SOD

81 G-H Type II pts

Stenosis BSP > 40 mmHg

Dyskinesia Abn response to CCK

ERCP with SOM

Dyskinesia Abn response to CCK

Normal

Toouli et al GUT 2000;46(1):98-102


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RANDOMIZATION BASED ON SOM

STENOSIS DYSKINESIA / NORMALSTENOSIS24 pts

DYSKINESIA / NORMAL57 pts

SPHX (13) SHAM (11) SPHX SHAM

Toouli et al GUT 2000;46(1):98-102

11/13IMPROVED

5/11IMPROVED

P= 0.041

NO DIFFERENCE

Clinical benefit according to G-H criteria

THERAPY TYPE II TYPE III TOTAL

ES (n=19)

5/6 (83%) 8/13 (62%)

13/19 (68%)

SHAM-ES (n=17)

2/7 (29%) 3/10 (30%)

3/17 (29%)

Ssp + Ccx (n=16)

8/10 (80%)

3/6 (50%)

11/16 (69%)

Sherman et al GIE 1994;40:A125


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SOM and Pancreatitis

RANDOMIZED TRIAL OF ASPIRATION VS NO ASPIRATION DURING PANCREATIC SOM

TECHNIQUE FREQUENCY

ASPIRATED 1/33 (3.0%)

INFUSED 8/34 (23.5%)

FAILED 2/9 (22 2%)

} p=.01 }p<.0

5FAILED 2/9 (22.2%)

TOTAL 11/76 (14.5%)

}5

GASTROINTEST ENDOSC 1990;36:462-6


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POST-ERCP PANCREATITIS

NO PANCREATITIS PANCREATITIS

BE

R O

F P

AT

IEN

TS

40

30

20

10

7% 26%P=0.003

RR=10.595%CI=1.4,78.3

NU

MB 10

0STENT NO STENT

Tarnasky et al Gastroenterology 1998;115(6):1518-24

Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction

EPISOD

G-H Type III – well defined

Randomized, sham controlled

Designed to evaluate predictability of SOM

d th ffi f hi t tand the efficacy of sphincterotomy

7 US centers


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EPISOD

All patients had SOM both ductsp

Randomized to sham vs sphincterotomy

◦ Sphincterotomy randomized to biliary or dual

2:1 randomization (sphx to sham)

Primary outcome is RAPID score at 12 mo

Recurrent Abdominal Pain Interference and Disability

RAPID

Developed from a migraine research tool

Validated for the EPISOD trial

Measures loss of productivity over 90 days in 3 domains

◦ Paid work or school

◦ Household activity

◦ Non-work activities

Grade 1:< 5, Grade 2: 6-11, Grade 3: 12-20, Grade 4:>20


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EPISOD Results

Most subjects in both arms were better at 3 mo.

• ITT @ 12 mo.ITT @ 12 mo.

◦ Sham: 37%

◦ Sphx: 23%

Biliary sphx: 19.2%

Dual sphx: 30%P=0.24

Complete data group:

◦ Sham: 42%

◦ Sphx: 24.6%

EPISOD II Results

I t ti id d b t Intervention guided by manometry

◦ Biliary sphincterotomy: 25%

◦ Dual sphincterotomy: 30%

◦ No treatment: 17%No treatment: 17%


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Complications

Pancreatitis: 26 patients

Sh %◦ Sham: 15%

◦ Sphincterotomy: 10.6%

Severity:

S 2◦ Severe: 2

◦ Moderate: 10

◦ Mild: 14

EPISOD conclusions

Sphincterotomy is no better than sham to

treat pain in type III SOD

SOM is not predictive of who will get better

with sphincterotomy

There is a very strong placebo effect in this There is a very strong placebo effect in this

group of patients


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Indications for SOM

Geenen- Hogan Type II

Unexplained (Idiopathic) pancreatitis

Selected Type III?

Florida Hospital Institute for Minimally Invasive Surgery

Center for Interventional Endoscopy


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Pancreatic stent placement: A meta-analysis of prospective, controlled trials

overall, pancreatitis rates were 3-fold higher in the non-stented group (15.5% vs 5.8%; OR 3.2: 95% C.I. 1.6-6.4

only 10 patients would need to undergo pancreatic stent placement to prevent one

d fepisode of pancreatitis

Singh et al., GIE 2004;60:544-50

Does the addition of aDoes the addition of aDoes the addition of aDoes the addition of apancreatic sphincterotomypancreatic sphincterotomyto biliary sphincterotomyto biliary sphincterotomyin SOD patients in SOD patients improve outcome?improve outcome?improve outcome?improve outcome?


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SPHINCTER OF ODDI MANOMETRYISOLATED SPHINCTER DYSFUNCTION

n ISOLATEDPSH

ISOLATEDBSH

BOTH TOTAL

280* 19% 9% 27% 55%

100# 17% 10% 37% 64%2

* EVERSMAN ET AL., GASTROINTEST ENDOSC 1996;43:381(A)

#KNAPPLE ET AL., GASTROINTEST ENDOSC 1996;43:385(A)

Type II Pancreatic SOD and recurrent pancreatitis: Type II Pancreatic SOD and recurrent pancreatitis: response to sphincter therapyresponse to sphincter therapy

TreatmentTreatment #patients#patientsTreatmentTreatment #patients #patients improved /total improved /total

patientspatientsBES alone 5/18 (28%)BES followed by pancreatic sphincter balloon dilation

13/24 (54%)sphincter balloon dilationBES + PES at later session 10/13 (77%)*BES + PES at same session 12/14 (86%)*

(Guelrud et al., GIE 1995;41:A398)

BES: biliary sphincterotomy; PES: pancreatic sphincterotomy*p<.005 vs BES alone


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Addition of a pancreatic sphincterotomy in Addition of a pancreatic sphincterotomy in pancreatic SOD improves outcome (n=361)pancreatic SOD improves outcome (n=361)

SODSODBiliary Biliary

sphincterotomysphincterotomyPancreatic Pancreatic

sphincterotomysphincterotomyTotal Responders Total Responders

Biliary* 225 189/215 0 0y /(88%)

Pancreatic 25/26 16 (64%)

Soffer and Johlin, Dig Dis Sci 1994;39:1942-6)

*mostly Type II patients

Response to Sphincterotomy Depends on Treating Response to Sphincterotomy Depends on Treating Diseased Sphincter (F/UDiseased Sphincter (F/U--17 mos)17 mos)

SO Biliary ES Pancreatic ESDysfunction Total Response Total Response

Biliary 10 8 (80%) 0 0 (0%)Pancreatic 13 2 (15%) 11 8 (72%)

Combined 10 5 (50%) 5 3 (60%)

Total 33 15 (45%) 16 11 (69%)Total 33 15 (45%) 16 11 (69%)

Kaw et al., GIE 1996;43:384A; Overall benefit 26/33 (79%)


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Causes for Persistent Symptoms after Causes for Persistent Symptoms after Biliary Sphincterotomy in SODBiliary Sphincterotomy in SOD

Residual or recurrent biliary SOD - rare Residual or recurrent biliary SOD rare

Pancreatic SOD - common

Chronic pancreatitis

Other untreated pancreaticobiliarydisease

Non-pancreaticobiliary diseases especially gut motility disorders

Pancreatic Sphincterotomy May Lead to Improved Pancreatic Sphincterotomy May Lead to Improved Outcome in SOD Patients who Fail to Respond to Outcome in SOD Patients who Fail to Respond to Biliary Sphincterotomy AloneBiliary Sphincterotomy Alone

70%

80%

n=43 Type I / II SOD

10%

20%

30%

40%

50%

60%

70%72%

19%

n 43, Type I / II SOD

p=NS p=NS

0%Complete

resolution ofsymptoms

Partial or transientchange

No change insymptoms

9%

Pancreatic manometry performed in only 6 patients post-BES

Elton et al., GIE 1998;47:240-9


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SOD: LongSOD: Long--term outcome following biliary term outcome following biliary sphincterotomy correlates with initial SOM resultssphincterotomy correlates with initial SOM results

Sphincter segment

Initial Sphincter Basal Pressure

BiliaryPancreas

ElevatedNormal

ElevatedElevated

NormalElevated

37 62 33n 37 62 33

Re-intervention 16%a 29%b 39%c

p<.05: a vs b, a vs cEversman et al., GIE 1999;49:AB78

LongLong--term Outcome after Biliary Sphincterotomy term Outcome after Biliary Sphincterotomy alone depends on Pancreatic SO Pressurealone depends on Pancreatic SO PressureLongLong--term Outcome after Biliary Sphincterotomy term Outcome after Biliary Sphincterotomy alone depends on Pancreatic SO Pressurealone depends on Pancreatic SO Pressure

% improved

% improved

5-yr F/U5-yr F/U80%

50% 46%

Eversman et al., GIE 1999;49:AB78

n=22 n=23 n=19


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Is the reIs the re--intervention rate diminished by dual intervention rate diminished by dual pancreatobiliary sphincterotomy in SOD patients? pancreatobiliary sphincterotomy in SOD patients?

Basal Biliary Abn Normal AbnormalBasal sphincter pressure

Biliary Abn Normal Abnormal

Pancreas

Normal Abnormal Abnormal

Rate ofRe-

DES 25% (7/28)a

21.3% (23/108)b

26.6% (47/177)c

Re-intervention

BES 16.2% (6/37)d

39.4% (13/33)e

29% (18/62)f

b vs e: p<.05; a vs d, c vs f: p=NSFollow-up: mean 43.1 months Park et al., GIE 2003;57:483-91

DES: dual sphincterotomy; BES: biliary sphincterotomy

SOD and sphincterotomy: SOD and sphincterotomy: Biliary? Pancreatic? Both?Biliary? Pancreatic? Both?

Overall, it appears that patient outcome may be improved by the addition of a pancreatic sphincterotomy in select patients (i.e. pancreatic SOD)

Investigators differ as to whether dual sphincterotomies should be performed in all SOD patients, or only when symptoms persist ft bili hi t tafter biliary sphincterotomy:

recurrent pancreatitis → dual sphincterotomy?

biliary Type I / II → biliary sphincterotomy?


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SOD and sphincterotomy: SOD and sphincterotomy: Biliary? Pancreatic? Both?Biliary? Pancreatic? Both?

randomized prospective trials comparing randomized prospective trials comparing single vs dual sphincterotomy in SOD patients are underway to further elucidate the most appropriate initial sphincter therapy based on SOM findings

h i b i h d i enthusiasm must be weighed against complication rates (pancreatitis)

what is the re-stenosis rate following pancreatic sphincterotomy?

The EPISOD studyThe EPISOD study

NIH funded sham controlled randomizedNIH funded sham controlled randomizedNIH funded, sham controlled, randomized NIH funded, sham controlled, randomized study study

Patients with SOD type IIIPatients with SOD type III

PostPost--cholecystectomy pain and normal labscholecystectomy pain and normal labsPostPost cholecystectomy pain and normal labs, cholecystectomy pain and normal labs, scansscans

www.clinicaltrials.gov


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EPISOD PIs and sitesEPISOD PIs and sites

Cotton/Romagnuolo; MUSC, Charleston, SC

Fogel; Indiana University, Indianapolis, IN

Freeman; U Minn, Berman Center, Minneapolis, MN

Wilcox; UAB, Birmingham, AL

Jagganath/Kalloo; Johns Hopkins, Baltimore, MD

Kozarek; Virginia Mason Medical Center Seattle WA Kozarek; Virginia Mason Medical Center, Seattle, WA

Tarnasky; Methodist Medical Center, Dallas, TX

Aliperti: Midwest Therapeutic Endoscopy Consultants, St Louis, MO

COMPLICATIONS OF 2,347 BILIARY COMPLICATIONS OF 2,347 BILIARY SPHINCTEROTOMIES BY INDICATION:SPHINCTEROTOMIES BY INDICATION:suspected SOD is highsuspected SOD is high--riskrisk

Freeman et al, NEJM 1996

PerforationPerforationHemorrhageHemorrhagePancreatitisPancreatitis

CholangitisCholangitisCholecystitisCholecystitisMiscellaneousMiscellaneous

Suspected SO Suspected SO DysfunctionDysfunction

(n=272)(n=272)

MiscellaneousMiscellaneousindications indications

(n=184)(n=184)

Stone not within 1 Stone not within 1 month of lap month of lap cholechole

(n=1,113)(n=1,113)

Stent strictureStent stricture--benignbenign(n=98)(n=98)

Stent strictureStent stricture--malignantmalignant(n=310)(n=310)

Stone within 1 month Stone within 1 month of lap of lap cholechole

(n=487)(n=487)


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IDIOPATHIC PANCREATITISIDIOPATHIC PANCREATITIS

# SOD PANC DIV

BIL STONES/CRYST

OTHER % DEFINED

% IDIOPATH

VENU ‘89

116 15% 9% 7% 7% 38% 62%

SHERMAN ‘93

55 33% 15% 5% 11% 64% 36%

BRODMERKEL ‘96*

58 47% 10% 14% 5% 88% 12%

MUSC ‘96

68 35% 16% 15% 10% 76% 24%

* RESULTS INCLUDE 7 PTS (12%) WITH BOTH SOD AND BILIARY CRYSTALS

SOM tracing


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MOST IMPORTANT ASPECT OF MOST IMPORTANT ASPECT OF SOM SOM

ABNORMAL BASAL SO PRESSURES

PREDICT OUTCOME AFTER

SPHINCTEROTOMY


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Diagnosis and management of SOD - American...

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