Sphincterotomy for biliary sphincter of Oddi dysfunction

Sphincterotomy for biliary sphincter of Oddi dysfunction

(Review)

Craig A,T oouli J

This is a reprint of a Cochrane review,prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2009,Issue1

https://www.360docs.net/doc/023813587.html,

T A B L E O F C O N T E N T S HEADER.......................................

1 ABSTRACT......................................

1 PLAIN LANGUAGE SUMMARY..............................

2 BACKGROUND....................................

2 OBJECTIVES.....................................

3 METHODS......................................

3 RESULTS.......................................

3 DISCUSSION.....................................

4

4 AUTHORS’CONCLUSIONS............................... REFERENCES.....................................

5 CHARACTERISTICS OF STUDIES.............................

7

11 DATA AND ANALYSES..................................

https://www.360docs.net/doc/023813587.html,parison1Sphincterotomy versus placebo for sphincter of Oddi basal pressure>40mmHg,Outcome1 Symptomatic cure/improvement (11)

https://www.360docs.net/doc/023813587.html,parison1Sphincterotomy versus placebo for sphincter of Oddi basal pressure>40mmHg,Outcome2 Symptomatic cure/improvement beyond two years (12)

https://www.360docs.net/doc/023813587.html,parison2Sphincterotomy versus placebo for sphincter of Oddi basal pressure<40mmHg,Outcome1 Symptomatic cure/improvement (12)

https://www.360docs.net/doc/023813587.html,parison2Sphincterotomy versus placebo for sphincter of Oddi basal pressure<40mmHg,Outcome2 Symptomatic cure/improvement beyond two years (13)

13 WHAT’S NEW..................................... HISTORY.......................................

13 CONTRIBUTIONS OF AUTHORS.............................

13

13 DECLARATIONS OF INTEREST..............................

INDEX TERMS....................................

14

[Intervention Review]

Sphincterotomy for biliary sphincter of Oddi dysfunction

Alexander Craig1,James T oouli2

1Adelaide,Australia.2Dept of General and Digestive Surgery,Flinders Medical Centre,Adelaide,Australia

Contact address:Alexander Craig,Adelaide,SA5042,Australia.sandy@https://www.360docs.net/doc/023813587.html,.au.

Editorial group:Cochrane Hepato-Biliary Group.

Publication status and date:Edited(no change to conclusions),published in Issue1,2009.

Review content assessed as up-to-date:5September2000.

Citation:Craig A,T oouli J.Sphincterotomy for biliary sphincter of Oddi dysfunction.Cochrane Database of Systematic Reviews2001, Issue1.Art.No.:CD001509.DOI:10.1002/14651858.CD001509.

Copyright?2009The Cochrane Collaboration.Published by John Wiley&Sons,Ltd.

A B S T R A C T

Background

The sphincter of Oddi regulates both bile and pancreatic juice?ow into the duodenum.When dysfunction occurs it leads to problems relating to either the bile or pancreatic ducts.On the biliary side,the most common problem is recurrent biliary type pain following cholecystectomy.

Objectives

Is sphincterotomy effective treatment for biliary sphincter of Oddi dysfunction patients?

Search strategy

Electronic data bases,including the Collaborative Review Group trial registers,MEDLINE,and EMBASE,as well as checking reference lists in as many languages as possible that had the titles:sphincter of Oddi dysfunction,biliary dyskinesia,papillary stenosis,biliary dyssynergia,odditis,papillitis,post-cholecystectomy pain,right upper quadrant pain,or unexplained right upper quadrant pain were included.These titles were matched with sphincterotomy.

Selection criteria

Randomised placebo-controlled trials performing sphincterotomy in patients with suspected biliary sphincter of Oddi dysfunction using manometry as part of the patient evaluation.A basal pressure>40mmHg was de?ned as abnormal.The primary outcome measure was symptomatic response(de?ned either as cure/improvement or not improved)to sphincterotomy.

Data collection and analysis

Electronic data bases were used to search for the studies.Studies were attempted to be strati?ed as randomised clinical trials,controlled clinical trials(i.e.,quasi-randomised clinical trials),well designed observational studies using a well matched control group,or other. These groupings were then entered into a meta-analysis.

Main results

Only two randomised clinical trials met the inclusion criteria.In49patients studied,sphincterotomy was more effective than placebo in treating patients with an elevated basal pressure(Peto odds ratio9.08,95%con?dence interval2.97-277.77).In77patients studied, sphincterotomy was no better than placebo in treating patients with a normal basal pressure(Peto odds ratio1.28,95%con?dence interval0.52-3.13).There were no data on quality of life or health economics.

Authors’conclusions

These results suggest that sphincterotomy for biliary sphincter of Oddi dysfunction appears effective in those patients with an elevated sphincter of Oddi basal pressure(>40mmHg),but is no better than placebo in those patients with a normal basal pressure.The results reported in this review must be interpreted with caution as there are only two studies and one of the reviewers(T oouli)has been an author in both studies.Further trials by independent groups are recommended.

P L A I N L A N G U A G E S U M M A R Y

Still awaiting evidence for sphincterotomy for biliary sphincter of Oddi dysfunction

Sphincterotomy for biliary sphincter of Oddi dysfunction in patients with a manometrically documented high basal pressure looks attractive,but should not be offered outside new randomised clinical trials.

B A

C K G R O U N D

The sphincter of Oddi regulates both bile and pancreatic juice ?ow into the duodenum.Sphincter of Oddi dysfunction(SOD) is seen as several clinical entities.When dysfunction occurs it leads to problems relating to either the bile or pancreatic ducts.On the biliary side,the most common problem is recurrent biliary type pain following cholecystectomy although there is some evidence suggesting that the gallbladder does not have to be removed to cause pain(Ruffolo1994).With respect to the pancreatic duct, SOD causes idiopathic recurrent pancreatitis(PSOD).This re-view will only consider the biliary form of SOD(BSOD).Nomen-clature has been a problem with numerous terms being used in the past that are now known as BSOD.Some of these other terms include biliary dyskinesia,papillary stenosis,biliary dyssynergia, odditis,or papillitis.The term papillitis followed the recognition of in?ammatory changes in surgical specimens of the ampulla of Vater(Acosta1966).

The true extent of BSOD is dif?cult to know.In a study30years ago(Bodvall1967),23.5%of1900patients2-9years following cholecystectomy complained of mild biliary pain.In another more recent study(Bar-Meir1984),29of454post-cholecystectomy patients(i.e.,6.4%)complained of pain for which no cause could be found.Fifteen of the29patients agreed to undergo sphincter of Oddi manometry,and two of the15patients had abnormal manometry.From these data it is estimated that1per cent of all patients undergoing cholecystectomy will suffer from BSOD.At present approximately500000cholecystectomies are performed annually in the USA(Grace1990).

Patients presenting with post-cholecystectomy pain need to ini-tially have biliary(e.g.,common bile duct stones)and non-biliary (e.g.,peptic ulcer disease)causes for their pain excluded.There are several methods for evaluating BSOD.Sphincter of Oddi perfu-sion manometry has been developed as a way of assessing sphinc-ter of Oddi motility and abnormal values have been determined as three standard deviations from normal values(T oouli1985) with a sphincter of Oddi basal pressure>40mmHg being consid-ered abnormal.This value has been approximated in other reports (Raddawi1991:40mmHg2standard deviations from the mean of normal;Guelrud1990:35mmHg three standard deviations from the mean of normal)and has generally become a uniform value for an abnormally elevated sphincter of Oddi basal pressure.A clin-ically based system has been promoted by some(Hogan/Geenen types I,II,III(Hogan1988)using liver function test abnormalities and?ndings at endoscopic retrograde cholangio-pancreatography (ERCP)with a dilated common bile duct or delayed drainage of contrast as a way of determining the likelihood of BSOD being present.This system correlates well with manometry for the type I patients(all three abnormalities),but the correlation is poor with the other two groups.For this reason,manometry is considered the best method of assessing patients with suspected BSOD,although the procedure is invasive and carries a small risk of pancreatitis and is not readily available in all hospitals.Noninvasive biliary scintigraphy shows promise in some studies when compared with manometry(Sostre1992;Corazziari1993;Madacsy2000),but the variables used in this technique are not standardised in routine practice.

The treatment of BSOD with sphincterotomy has been recog-nised to be effective in some patients but determining appropri-ate selection criteria has proven dif?cult,especially for the type II and III patients.Appropriate selection of patients with suspected BSOD for sphincterotomy is important given the risk of pan-creatitis and other complications from sphincterotomy,includ-

ing death(Chen1994).There are many cohort studies,some of them randomised trials,that appear to show a bene?t in pa-tients with an elevated basal pressure.We have undertaken a meta-analysis(unpublished data)in the studies that compared re-sponses to sphincterotomy in patients who had manometry per-formed as part of their diagnostic evaluation.In the six studies performed(Botoman1994b;Neoptolemos1988b;Rolny1993b; Rolny1997b;Roberts-Thomson1985b;Wehrmann1999b),173 patients in total have undergone sphincterotomy.Of those patients with an elevated biliary pressure,71/94showed improvement fol-lowing sphincterotomy,compared with only40/79patients with a normal biliary pressure(Peto odds ratio2.78;95%con?dence interval(CI)1.40-5.49).The rate of pancreatitis that was able to be gleaned from four of the six studies was10.6%(9/85pa-tients).There were no reports of death.These data certainly sug-gests that sphincterotomy could be a valid treatment intervention in patients with BSOD,but this procedure needs to be subjected to randomised,placebo-controlled studies before sphincterotomy can be recommended with con?dence.The aim of this system-atic review was to explore the available literature for placebo-con-trolled studies undertaking sphincterotomy for suspected BSOD that had included sphincter of Oddi manometry in the diagnostic evaluation of patients.

O B J E C T I V E S

Is sphincterotomy effective treatment for BSOD compared to placebo in patients who have undergone manometry as part of their diagnostic evaluation?

M E T H O D S

Criteria for considering studies for this review

T ypes of studies

All studies treating BSOD with surgical or endoscopic sphinctero-tomy that have included a placebo/control group.

T ypes of participants

Patients with biliary type pain suspected to be BSOD who have undergone manometry.

T ypes of interventions

Sphincterotomy.T ypes of outcome measures

The primary outcome measure was symptomatic response(de?ned either as cure/improvement or not improved)to sphincterotomy.

Search methods for identi?cation of studies Electronic data bases,including the Collaborative Review Group trial registers,MEDLINE,and EMBASE,as well as checking ref-erence lists in as many languages as possible that had the titles: sphincter of Oddi dysfunction,biliary dyskinesia,papillary steno-sis,biliary dyssynergia,odditis,papillitis,post-cholecystectomy pain,right upper quadrant pain,or unexplained right upper quad-rant pain were included.These titles were matched with sphinc-terotomy.

Data collection and analysis

Both reviewers selected the studies to be included and excluded. Studies to be included were those that had studied patients with suspected BSOD who had undergone manometry as part of their diagnostic evaluation,that had undergone surgical or endoscopic sphincterotomy,and the study had included a placebo/control group.

Studies were attempted to be strati?ed as(1)randomised clinical trials,(2)controlled clinical trials(i.e.,quasi-randomised clinical trials),(3)well designed observational studies using a well matched control group,or(4)other.

The results assessing the primary outcome measure of the studies strati?ed as described above were entered into a meta-analysis using RevMan.

A sensitivity analysis was then performed to test the robustness of the results by excluding those studies that followed patients for less than two years.

R E S U L T S

Description of studies

See:Characteristics of included studies;Characteristics of excluded studies.

T wenty-four studies were identi?ed from the search strategy. T wenty-two of these studies were excluded because of the lack of a placebo/control group and in some cases no manometry had been undertaken.

There were two randomised clinical trials that had included a placebo/control group(Geenen1989;T oouli2000)and analysis on two groups within study populations was made depending on whether the biliary pressure was normal or elevated.The Geenen

trial was performed from1980-1983and the T oouli trial from 1987-1996.

Only one trial clearly assessed response to sphincterotomy for two years or beyond(T oouli2000),whilst the other after one year following the sphincterotomy or sham procedure,offered sphinc-terotomy to all the patients who had undergone the sham proce-dure(Geenen1989).

Both trials included patients with recurrent biliary pain for which no cause be found and included only post-cholecystectomy pa-tients in whom the original surgery had not found evidence of common bile duct stones(i.e.,no previous common bile duct ex-ploration)and common bile duct stones were excluded prior to entry into both trials.One of the trials only included type II pa-tients(Geenen1989)whilst the other mainly included type II pa-tients with small numbers of type I and III patients(T oouli2000), as the entry criteria for this study was pain with at least one of the following:positive morphine-neostigmine test,abnormal liver function tests,or a dilated common bile duct.

Risk of bias in included studies

Both trials were well perfomed with independent assessment of the response to sphincterotomy that included concealment of ran-domisation to both the independent reviewer and participant.The efforts to incorporate a placebo/control group were novel(sham procedure).Blinding occurred for the duration of study enrol-ment.

The trials differed slightly in that the Geenen trial(Geenen1989) randomised patients to sphincterotomy or sham procedure before manometry was performed while the T oouli trial(T oouli2000) randomised participants on the basis of manometry.The Geenen trial offered sphincterotomy at one year to patients who had un-dergone an original sham procedure,and although the trial in-cluded follow up for four years,for the purpose of this review,only the?rst year of the trial results were included.

Effects of interventions

T wo comparisons were undertaken to assess the primary outcomes: (1)For patients with an elevated basal pressure(>40mmHg): sphincterotomy versus placebo,with comparisons for all trials and those that assessed the response symptomatic cure improvement for two years and beyond.The Peto odds ratio for the two trials was9.08(95%con?dence intervals(CI)2.07-277.77)and for the one study that assessed response for two years(T oouli2000)the Peto odds ratio was6.52(95%CI1.38-30.71).

(2)For patients with a normal basal pressure(<40mmHg):sphinc-terotomy versus placebo,with comparisons for all trials and those that assessed the response symptomatic cure improvement for two years and beyond.The Peto odds ratio for the two studies was1.28 (95%CI0.52-3.13)and for the one trial that assessed response for two years(T oouli2000)the Peto odds ratio was1.23(95%CI 0.42-3.59).The P values were0.6and0.7,respectively.

There was no data on quality of life or health economics in the two studies.Data on adverse events was not easily interpretable as there were many interventions at different times and overall numbers were given rather than data for each intervention.No deaths were recorded.

D I S C U S S I O N

There appears to be clear bene?t for patients with suspected bil-iary sphincter of Oddi dysfunction and an elevated basal pressure on manometry undergoing sphincterotomy versus placebo(Peto odds ratio>9)although the results reported in this review must be interpreted with caution.The numbers of studies are small and the total number of patients studied is only128.It is also impor-tant to consider that these two trials were performed by the same researcher and co-author of this review(T oouli).

These two trials did differ slightly.The Geenen trial(Geenen 1989)did not randomise patients to sphincterotomy or a sham procedure on the basis of the manometry,but rather found retro-spectively that manometry was able to predict response to sphinc-terotomy,and for that reason others have criticised this work as being an observational study.The two trials also differed slightly in the patient groups studied.The Geenen trial only included type II patients whereas the T oouli trial included type I,II,and III patients,although the majority of the patients were type II.In the T oouli trial no correlation was found between Geenen/Hogan type and response to sphincterotomy versus placebo.

A U T H O R S’C O N C L U S I O N S

Implications for practice

These results suggest that sphincterotomy for biliary sphincter of Oddi dysfunction appears effective in those patients with an el-evated sphincter of Oddi basal pressure(>40mmHg)but is no better than placebo in those patients with a normal basal pressure. The results reported in this review must be interpreted with cau-tion as there are only two included trials and one of the review-ers(T oouli)has been an author in both studies.We would rec-ommend that sphincterotomy for patients with manometrically proven biliary sphincter of Oddi dysfunction be considered in the context of new randomised clinical trials.

Implications for research

Further studies by independent groups is recommended.In par-ticular we would recommend studies which include patients with manometrically proven biliary sphincter of Oddi dysfunction that

prospectively randomise patients to sphincterotomy or a sham

placebo in a double blind fashion.These studies need to have

quali?ed independent assessors of subject follow up following the intervention and data need to be collected on quality of life,health economics,and adverse events.

R E F E R E N C E S

References to studies included in this review Geenen1989{published data only}

?Geenen JE,Hogan WJ,Dodds WJU,T oouli J,Venu

RP.The ef?cacy of endoscopic sphincterotomy after

cholecystectomy in patients with sphincter of Oddi

dysfunction.New England Journal of Medicine1989;320

(2):82–7.

T oouli2000{published data only}

?T oouli J,Roberts-Thomson IC,Kellow J,Dowsett J,

Saccone GTP,Evans P,et al.Manometry based randomised trial of endoscopic sphincterotomy for sphincter of Oddi

dysfunction.Gut2000;46(1):98–102.

References to studies excluded from this review Botoman1994{published data only}

Botoman VA,Kozarek LA,Novell DJ,Patterson TJ,Ball D, Wetcher G,et al.Longterm outcome after sphincterotomy in patients with biliary colic and suspected sphincter of Oddi dysfunction.Gastrointestinal Endsocopy1994;40:165–70. Bozkurt1996{published data only}

?Bozkurt T,Orth KH,Butsch B,Lux G.Long-term clinical outcome of post-cholecystectomy patients with biliary-

type pain:results of manometry,non-invasive techniques

and endoscopic sphincterotomy.European Journal of

Gastroenterology and Hepatology1996;8(3):245–9.

Chen1994{published data only}

?Chen YK,Foliente RL,Santoro MJ,Walter MH,Collen

MJ.Endoscopic sphincterotomy-induced pancreatitis:

increased risk associated with nondilated bile ducts and

sphincter of Oddi dysfunction.The American Journal of

Physiology1994;89(3):327–33.

Choudhry1993{published data only}

?Choudhry U,Ruffolo T,Jamidar P,Hawes R,Lehman

G.Sphincter of Oddi dysfunction in patients with

intact gallbladder:therapeutic response to endoscopic

sphincterotomy.Gastrointestinal Endoscopy1993;39:492–5. Fullarton1992{published data only}

?Fullarton GM,Murray WR.Evaluation of endoscopic

sphincterotomy in sphincter of Oddi dysfunction.

Endoscopy1992;24:199–202.

Gregg1984{published data only}

?Gregg JA,Carr-locke DL.Endoscopic pancreatic and

biliary manometry in pancreatic biliary and papillary

disease and after endoscopic sphincterotomy and surgical

sphincteroplasty.Gut1984;25:1247–54.Hastbacka1986{published data only}

?Hastbacka J,Jarvinen H,Kivilaakso E,T urunen MT.

Results of sphincteroplasty in patients with spastic sphincter of Oddi:predictive value of operative biliary manometry

and provocation tests.Scand J Gastroenterol1986;21:

516–20.

Hwang1996{published data only}

?Hwang JS,Lai KH,Lo GH,Wang EM,Wang NM,

Cheng JS,et al.The ef?cacy of endoscopic sphincterotomy in patients with sphincter of Oddi dysfunction.Chinese

Medical Journal1996Mar;57(3):177–83.

Lin1998{published data only}

?Lin OS,Soetikno RM,Young HS.The utility of liver

function test abnormalities concomitant with biliary

symptoms in predicting a favourable response to endoscopic sphincterotomy in patients with presumed sphincter of

Oddi dysfunction.American Journal of Gastroenterology

1998;93(10):1833–6.

Neoptolemos1988{published data only}

Neoptolemos J P,Bailey I S,Carr-Locke D L.Sphincter

of Oddi dysfunction:results of treatment by endoscopic

sphincterotomy.British Journal of Surgery1988;75(5):

454–9.

Orchard1985{published data only}

?Orchard JL,Bickerstaff CA,Brady P.Biliary dyskinesia:

diagnosis by common bile duct manometry and treatment

by endoscopic sphincterotomy.Journal of the South

Caroloina Medical Association1985;81(9):503–5. Roberts-Thomson1985{published data only}

Roberts-Thomson IC,T oouli J.Is endoscopic

sphincterotomy for disabling biliary type pain effective?.

Gastrointesinal Endoscopy1985;31(6):370–3.

Rolny1993{published data only}

?Rolny P,Geenen JE,Hogan W J.Post-cholecystectomy

patients with“objective signs”of partial bile out?ow

obstruction:clinical characteristics,sphincter of Oddi

manometry?ndings and results of therapy.Gastrointesinal

Endoscopy1993;39:778–81.

Rolny1997{published data only}

?Rolny P.Endoscopic bile duct stent placement as a

predictor of outcome following endoscopic sphincterotomy in patients with suspected sphincter of Oddi dysfunction.

European Journal of Gastroenterology and Hepatology1997;9

(5):467–71.[MEDLINE:97331547]

Sherman1991{published data only}

?Sherman S,Ruffolo T A,Hawes R H,Lehman G A.

Complications of endoscopic sphincterotomy:a prospective series with emphasis on the increased risk associated with

sphincter of Oddi dysfunction and nondilated bile ducts.

Gastroenterology1991;101:1068–75.

Tarnasky1998{published data only}

?Tarnasky PR,Palesch YY,Cunningham JT,Mauldin

PD,Cotton PB,Hawes RH.Pancreatic stenting prevents

pancreatitis after biliary sphincterotomy in patients with

sphincter of Oddi dysfunction.Gastroenterology1998;115: 1518–24.

T estoni1991{published data only}

?T estoni PA,Tittobello A.Long-term ef?cacy of endoscopic papillo-sphincterotomy for common bile duct stones and

benign papillary stenosis.Surg Endosc1991;5:135–9. Thatcher1987{published data only}

?Thatcher BS,Sivak MV,T edesco FJ,Vennes JA,Hutton

SW,Achkar EA.Endospcopic sphincterotomy for suspected dysfunction of the sphincter of Oddi.Gastrointesinal

Endoscopy1987;33:91–5.

Viceconte1995{published data only}

?Viceconte G,Micheletti A.Endoscopic Manometry of

the Sphincter of Oddi:Its Usefulness for the Diagnosis

and T reatment of Benign Papillary Stenosis.Scand J

Gastroenterol1995;30:797–803.

Wehrmann1995{published data only}

?Wehrmann T,Wiemer K,Lembcke B,Jung M.Effect

of endoscopic sphincterotomy on sphincter of Oddi

manometry results in patients with or without papillary

stenosis.Zeitschrift für Gastroenterologi1995;33(11):662–8. Wehrmann1996{published data only}

?Wehrmann T,Wiemer K,Lembcke B,Caspary WF,Jung M.Do patients with sphincter of Oddi dysfunction bene?t from endoscopic sphincterotomy?A5-year prospective

trial.European Journal of Gastroenterology and Hepatology

1996;8(3):251–6.

Wehrmann1999{published data only}

?Wehrmann T,Lembcke B,Caspary W,Seifert H.

Sphincter of Oddi dysfunction after successful gallstone

lithotripsy.Digestive Diseases and Sciences1999;44(11):

2244–50.

Additional references

Acosta1966

Acosta JM,Nardi GL.Papillitis.In?ammatory disease

of the ampulla of Vater.Archives of Surgery1966;92(3):

354–61.

Bar-Meir1984

Bar-Meir S,Halpern Z,Bardan E,Gilat T.Frequency of

papillary dysfunction among cholecystectomised patients.

Hepatology1984;4(2):328–30.Bodvall1967

Bodvall B,Overgaard https://www.360docs.net/doc/023813587.html,puter analysis of post-

cholecystectomy biliary tract symptoms.Surgery,

Gynaecology,and Obstetrics1967;124(4):723–32. Botoman1994b

Botoman VA,Kozarek RA,Novell LA,Patterson DJ,Ball

TJ,Wechter DG,et al.Long-term outcome after endoscopic sphincterotomy in patients with biliary colic and suspected sphincter of Oddi dysfunction.Gastrointesinal Endoscopy

1994;40(2):165–9.

Corazziari1993

Corazziari E,Cicala M,Habib FI,Scopinaro F,Fiocca

F,Pallotta N,et al.Hepatoduodenal bile transit in

cholecystectomised subjects.Relationship with sphincter of Oddi function and diagnostic value.Digestive Diseases and Sciences1993;39(9):1985–93.

Grace1990

Grace P,Postone G,Williamson R.Biliary motility.Gut

1990;31:571–82.[MEDLINE:1990276908]

Guelrud1990

Guelrud M,Mendoza S,Rossiter G,Villegas M.Sphincter of Oddi manometry in healthy volunteers.Digestive Diseases and Sciences1990;35(1):38–46.

Hogan1988

Hogan WJ,Geenen JE.Biliary dyskinesia.Endoscopy1988;

20:179–83.

Madacsy2000

Madacsy L,Middelfart HV,Matzen P,H?jgaard L,Funch-Jensen P.Quantitative hepatobiliary scintigraphy and

endoscopic sphincter of Oddi manometry in patients with

suspected sphincter of Oddi dysfunction:assessment of

the?ow pressure relationship in the biliary tract.European Journal of Gastroenerology and Hepatology2000;12:777–86. Neoptolemos1988b

Neoptolemos JP,Bailey IS,Carr-locke DL.Sphincter of

oddi dysfunction:results of treatment by endoscopic

sphincterotomy.British Journal of Surgery1988;75(5):

454–9.[MEDLINE:88269979]

Raddawi1991

Raddawi HM,Geenen JE,Hogan WJ,Dodds WJ,Venu

RP,Johnson KJ.Pressure measurements from biliary and

pancreatic segments of sphincter of Oddi.Digestive Diseases and Sciences1991;36(1):71–4.

Roberts-Thomson1985b

Roberts-Thomson IC,T oouli J.Is endoscopic

sphincterotomy for disabling biliary type pain after

cholecystectomy effective.Gastrointesinal Endoscopy1985;

31:370–402.

Rolny1993b

Rolny P,Geenen JE,Hogan WJ.Post-cholecystectomy

patients with’objective signs’of partial bile out?ow

obstruction:clinical characteristics,sphincter of Oddi

manometry?ndings and results of therapy.Gastrointesinal

Endoscopy1993;39:778–81.

Rolny1997b

Rolny P.Endoscopic bile duct stent placement as a predictor of outcome following endoscopic sphincterotomy in

patients with suspected sphincter of Oddi dysfunction..

European Journal of Gastroenterology and Hepatology1997;9

(5):467–71.

Ruffolo1994

Ruffolo T,Sherman S,Lehman G,Hawes R.Gallbladder

ejection fraction and its relationship to sphincter of Oddi

dysfunction.Digestive Diseases and Sciences1994;39:

289–92.[MEDLINE:1994147890]

Sostre1992

Sostre S,Kalloo A N,Spiegler E J,Camargo E E,Wagner

H N.A noninvasive test of sphincter of Oddi dysfunction

in postcholecystectomy patients:the scintigraphic score.

Journal of Nuclear Medicine1992;33(6):1216–22.

T oouli1985

T oouli J,Roberts-Thomson IC,Dent J,Lee J.Manometric disorders in patients with suspected sphincter of Oddi

dysfunction.Gastroenterology1985;88:1243–50. Wehrmann1999b

Wehrmann T,Lembcke B,Caspary W,Seifert H.Sphincter of Oddi dysfunction after successful gallstone lithotripsy.

Digestive Diseases and Sciences1999;44(11):2244–50.

?Indicates the major publication for the study

C H A R A C T E R I S T I C S O F S T U

D I

E S Characteristics of included studies[ordered by study ID] Geenen1989

Methods

Participants

Interventions

Outcomes

Notes

Item Authors’judgement

Allocation concealment?Yes

T oouli2000

Methods

Participants

Interventions

T oouli2000(Continued)

Outcomes

Notes

Item Authors’judgement

Allocation concealment?Yes

Characteristics of excluded studies[ordered by study ID]

Study

Botoman1994

Bozkurt1996

Chen1994

Choudhry1993

Fullarton1992

Gregg1984

Hastbacka1986

Hwang1996

Lin1998

Neoptolemos1988

Orchard1985

Roberts-Thomson1985

Rolny1993

Rolny1997

Sherman1991

(Continued)

Tarnasky1998 T estoni1991 Thatcher1987 Viceconte1995 Wehrmann1995 Wehrmann1996 Wehrmann1999

D A T A A N D A N A L Y S

E S

Comparison1.Sphincterotomy versus placebo for sphincter of Oddi basal pressure>40mmHg

1Symptomatic cure/improvement249Peto Odds Ratio(Peto,Fixed,95%CI)9.08[2.97,27.77] 2Symptomatic cure/improvement

beyond two years

126Peto Odds Ratio(Peto,Fixed,95%CI) 6.52[1.38,30.71]

Outcome or subgroup title No.of

studies

No.of

participants Statistical method Effect size

https://www.360docs.net/doc/023813587.html,parison1Sphincterotomy versus placebo for sphincter of Oddi basal pressure>40

mmHg,Outcome1Symptomatic cure/improvement.

Review:Sphincterotomy for biliary sphincter of Oddi dysfunction

Comparison:1Sphincterotomy versus placebo for sphincter of Oddi basal pressure>40mmHg

Outcome:1Symptomatic cure/improvement

Study or subgroup Sphincterotomy Placebo Peto Odds Ratio Weight Peto Odds Ratio

n/N n/N Peto,Fixed,95%CI Peto,Fixed,95%CI

11 Sphincterotomy for biliary sphincter of Oddi dysfunction(Review)

Copyright?2009The Cochrane Collaboration.Published by John Wiley&Sons,Ltd.

https://www.360docs.net/doc/023813587.html,parison1Sphincterotomy versus placebo for sphincter of Oddi basal pressure>40 mmHg,Outcome2Symptomatic cure/improvement beyond two years.

Review:Sphincterotomy for biliary sphincter of Oddi dysfunction

Comparison:1Sphincterotomy versus placebo for sphincter of Oddi basal pressure>40mmHg

Outcome:2Symptomatic cure/improvement beyond two years

Study or subgroup Sphincterotomy Placebo Peto Odds Ratio Weight Peto Odds Ratio

n/N n/N Peto,Fixed,95%CI Peto,Fixed,95%CI

Geenen19895/124/1230.6% 1.41[0.28,7.09] T oouli200012/2413/2969.4% 1.23[0.42,3.59]

T otal(95%CI)3641100.0% 1.28[0.52,3.13] T otal events:17(Sphincterotomy),17(Placebo)

Heterogeneity:Chi2=0.02,df=1(P=0.89);I2=0.0%

T est for overall effect:Z=0.54(P=0.59)

0.10.210

Favours

https://www.360docs.net/doc/023813587.html,parison2Sphincterotomy versus placebo for sphincter of Oddi basal pressure<40 mmHg,Outcome2Symptomatic cure/improvement beyond two years.

Review:Sphincterotomy for biliary sphincter of Oddi dysfunction

Comparison:2Sphincterotomy versus placebo for sphincter of Oddi basal pressure<40mmHg

Outcome:2Symptomatic cure/improvement beyond two years

Study or subgroup Sphincterotomy Placebo Peto Odds Ratio Weight Peto Odds Ratio

n/N n/N Peto,Fixed,95%CI Peto,Fixed,95%CI

Description

Converted to new review format.

H I S T O R Y

Protocol?rst published:Issue2,1999

Review?rst published:Issue3,2001

C O N T R I B U T I O N S O F A U T H O R S

AC drafted the protocol,coordinated the identi?cation of studies,selected the trials for inclusion,performed the data extraction,and drafted the review.JT checked and revised all these processes.Both act as guarantors for the review.

D E C L A R A T I O N S O F I N T E R E S T

There is a possible academic con?ict of interest as the General and Digestive Surgical Unit at Flinders Medical Centre has an active research laboratory in the area of sphincter of Oddi dysfunction and has published widely on this topic.

I N D E X T E R M S

Medical Subject Headings(MeSH)

Common Bile Duct Diseases[?surgery];Con?dence Intervals;Odds Ratio;Randomized Controlled T rials as T opic;Sphincter of Oddi [?surgery]

MeSH check words

Humans