XECUTIVE SUMMARY RECOMMENDATIONS - PDF document

XECUTIVE SUMMARY & RECOMMENDATIONS patients with suspected oesophageal symptoms,flexible Evidence grade C and/or radiology, as manometry is the most accurate method Evidence grade C) Oesophageal manometry is the most accurate method forpH electrode placement Evidence grade BEvidence grade B Acid gastro-oesophageal reflux accounts for a significant Evidence grade C oesophageal reflux and have a primary motility disorder, such Evidence gradeC ).In the absence of locally determined ranges for defining thelimits of physiological acid reflux, the following data shouldbe utilised: percentage total time oesophageal pHpercentage upright time oesophageal pHsupine time oesophageal pH fo;&#xr 00;pH Evidence grade BEvidence grade B the time the event marker on the data logger was pressed Evidence grade BEvidence grade B Ameasure of the association of thepatientÕs symptoms and acid reflux episodes, such as thesymptom index, and the number of symptomatic events,should be included in the report of an ambulatoryoesophageal pH study Evidence grade CEvidence grade C Ambulatory oesophageal pH monitoring has no role in theinitial management of patients with symptoms suggestive ofacid gastro-oesophageal reflux. A high dose therapeutic trialof a proton pump inhibitor is the diagnostic investigation ofchoice Evidence grade BEvidence grade B during a therapeutic trial of a proton pump inhibitor, ambula- Evidence grade CEvidence grade C Chest pain, throat and respiratory symptoms may be due toacid gastro-oesophageal reflux, particularly in patients withheartburn or acid regurgitation and no alternative explana-tion for their symptoms. A high dose therapeutic trial of a pro-ton pump inhibitor is indicated in such patients (Evidencerade B) In patients with throat or respiratory symptomsthis trial should be for four months, as a symptomaticresponse may be delayed Evidence grade BEvidence grade B exclude excess acid gastro-oesophageal reflux when thisappears unlikely or pH monitoring on a proton pump inhibitor Evidence grade CEvidence grade C Patients with endoscopic oesophagitis and a good response (Evidence gradeC) .Patients with symptoms potentially due to acid reflux who Evidence grade CEvidence grade C Ambulatory oesophageal pH monitor-ing should be undertaken in patients with persistentsymptoms following anti-reflux surgerysurgery is planned, to ensure there is evidence of persistentacid reflux and a good correlation between the patientÕssymptoms and acid reflux episodes Evidence grade CEvidence grade C nose, and restrictions affecting diet and activity. Patients with (Evidencegrade C) All patients undergoing oesophageal manometry orambulatory oesophageal pH monitoring should give writteninformed consent Evidence grade CEvidence grade C Toensure high clinical standards in oesophageal functiontesting, all clinicians undertaking oesophageal manometry orpH monitoring in the United Kingdom should be registeredAGIPAGIP Evidence grade CEvidence grade C 1.0 INTRODUCTION Oesophageal disorders are among the most common medicalconditions. Symptoms of acid gastro-oesophageal reflux affectup to a third of the population in the UK. Oesophagealmanometry and ambulatory o

esophageal pH monitoring havebecome established clinical tools in the investigation ofoesophageal symptoms. There have been significant develop-ments in this field since the previous guidelines wereformulated in 1996, particularly the advent of proton pumpinhibitors and increasing awareness of the value of therapeu- Guidelines for oesophageal manometry and pH monitoring November 2006BSG Guidelines in Gastroenterology Guidelines for oesophageal manometry and pH Keith Bodger and Nigel Trudgill Aintree Centre for Gastroenterology, University Hospital Aintree, Liverpool, L9 7ALDepartment of Gastroenterology, Sandwell General Hospital, Lyndon, West Bromwich, West Midlands, B71 4HJ ic trials with these agents. These developments merit areassessment of the clinical role of oesophageal manometryand ambulatory oesophageal pH monitoring and this is thepurpose of these guidelines. 2.0 FORMULATION OF GUIDELINES ommendations of the Northof England evidence basedliterature search using the searchterms ÒoesophagealmanometryÓ and Òoesophageal pH monitoringÓ, and onexpert opinion and review. The application of oesophagealcopeof these guidelines. 2.1 CATEGORIES OF EVIDENCE ꔀIbÑEvidence obtained from at least one randomisedꔀIIaÑEvidence obtained from at least one well designedꔀIIbÑEvidence obtained from at least one other type of welldesigned quasi experimental study. 2.2 GRADING OF RECOMMENDATIONS ꔀGrade CÑrequires evidence from expert committee reports 3.0 OESOPHAGEAL MANOMETRY To perform oesophageal manometry in an accurate and repro- 3.1 EQUIPMENT Oesophageal manometry utilises a system of water-perfusedriting polygraphs) or via computer-generated reporting Water-perfused catheters coupled to volume-displacement monitored by a volume-displacement transducer. Water flow Solid-state strain gauges some than traditional water-perfused systems, but are moreexpensive both to buy and repair. There have been no studies High Resolution ManometrHRMHRM tiple sensors within the sphincters and oesophageal body.fixed position. The increased resolution and better radial 3.2 PATIENT PREPARATION AND TECHNIQUE metry.(2,5-12)Equipment should be checked and calibratedcally appropriate (eg. ?-blockers, nitrates, calcium channelblockers, anticholinergic drugs, prokinetics, nicotine, caffeine, Keith Bodger and Nigel Trudgill BSG Guidelines in GastroenterologyNovember 2006 ocal anaesthetic may be used and if so, its use should be doc-umented. A brief history and review of the patientÕs caserecords should alert the technician to any contra-indicationsoperforming oesophageal studies (See ection 5.0 atient should be placed in the recumbent position if a water-minutes to accommodate to the catheter. Water-perfused sys-At the beginning of the manometric assessment, one orpatient to take a deep breath. Intra-abdominal pressure read-Conversely, pressure readings taken within the thoracic cavitytively2,10,11,13-262,10,11,13-26 Evidence Grade: B at least threeat least three. Bothlowerlowerupperupperboth upper and lower oesophagus). (30) At least 20-30 sec-absent, the function of the sensors should be checked by ask- Evidence Grade: B ).(32) 3.3 INDICATIONS FOR OESOPHAGEAL MA

NOMETRY However, it should not be used as a first-line investigation forIn patients with suspected oesophageal symptoms,we rec- Evidence grade C excluded prior to seeking less common dysmotility disorders. Panel 1 Evidence Grade C ). A primaryindication for manometry is the evaluation of dysphagia ogy2,6,7,9-12,33-402,6,7,9-12,33-402,6,7,9-12,33-402,6,7,9-12,33-40,so-called Ònutcracker oesophagusÓ) are more controversial. Section 3.4 manometry17,26,41-5217,26,41-5244,46,53,54) Achalasia and diffuse oesophageal spasm appear5858A single controlled trial has reported Evidencegrade: C malities has been described in GORD, including dysfunction Guidelines for oesophageal manometry and pH monitoring November 2006BSG Guidelines in Gastroenterology SUMMARY OF INDICATIONS FOR OESOPHAGEALMANOMETRY 1)To diagnose suspected primary oesophageal motility2)To diagnose suspected secondary oesophageal motility3)To guide the accurate placement of pH electrodes for)As part of the pre-operative assessment of some5)To reassess oesophageal function in patients who have for most patients. Manometry is, however, recommended to Evidence gradeB) 5,7,9,10,37,38,63,645,7,9,10,37,38,63,64Itis recognised that GORD may account for a significantproportion of non-specific manometric abnormalities. A ther-apeutic trial of anti-reflux therapy (eg. a proton pumpnhibitor) is recommended prior to using less conventional,unlicensed drug treatments in patients with suspectedoesophageal symptoms who have non-specific motility abnor-alities identified at manometry ( vidence grade C patients being considered for anti-reflux surgery, the role forrelative contra-indication to anti-reflux surgery. However,fundoplication surgery. Pre-operative manometry does pre- Evidence grade: C 3.4 A CLASSIFICATION OF MOTILITY DISORDERS There is no internationally agreed classification system for theprimary oesophageal motility disorders, though one proposedscheme is given in Panel 2 7070manometric features of these disorders is beyond scope ofthese guidelines but a brief summary follows: Achalasia is the only primary motility disorder for whichan underlying pathological process has been well charac-34,40,7134,40,7111 isobaric or Òmirror imagesÓisobaric or Òmirror imagesÓ, these contractionslows in 70-80% of patients with achalasia. In the remainder,eg. barium radiologyeg. barium radiologyatients withder of the LOS.Such patients may have some degree ofreserved peristalsis, oesophageal body contractions exceed- iffuse oesophageal spasm cally by uncoordinated oesophageal contractions. Publishedcriteria have varied, but a key feature is the finding of simul-�7070, including sponta-multiple-peaked contractions. Normal peristalsis should bepresent intermittently. Incomplete relaxation of the LOS is not non-specific disorders of motility are described inwhich there is manometric evidence of either ÔhypertensiveÕor ÔhypotensiveÕ oesophageal contraction. The definition andclinical significance of these entities remains controver-7272 Nutcracker oesophagus is a term used to describehypertensive peristalsis, typically defined as an average distal�34,59,70,71,7334,59,70,71,73 Hypertensive LOS

refers to the finding of elevated resting�eg. 45mmHgeg. 45mmHgThe finding of weak and/or non-transmitted distaloesophageal contractions has led some authors to suggest ahypotensive category of ineffective oesophageal motil-ity manometry, either radiologically or with the emerging tech- hypotensive LOS ing LOS. Other non-specific manometric observations include 3.5 RECOMMENDATIONS FOR MANOMETRY REPORTING This section proposes a minimum dataset for oesophagealmanometry reporting, based on elements that are common to2,6-8,11,12,34,40,71,752,6-8,11,12,34,40,71,75Many units will produce more detailed reports but the pro-posed scheme represents a minimum standard.( EvidenceGrade C General information: The report should include patientidentification details, the date and timing of the test, the indi-cations for the procedure and a list of current medications.The report should stipulate whether the catheter was placedvia the mouth or nares. Details of the type of apparatus shouldie. type of catheter and recording deviceie. type of catheter and recording devicemedications used during the procedure should be noted. Ifany technical difficulties were encountered during the proce- Keith Bodger and Nigel Trudgill BSG Guidelines in GastroenterologyNovember 2006 TION OF PRIMARY OESOPHAGEAL ꔀInadequate LOS relaxationAchalasiaAtypical disorders of LOS relaxationꔀUncoordinated contractionꔀHypertensive contractionNutcracker oesophagus ure, such as patient intolerance or problems with catheterlacement or equipment function, these should be recorded. ower oesophageal sphincter The ocation fthe upperand lower border of the high pressure zone HPZHPZnoted, as measured from the nares or incisors. This allows cal-culation of LOS length Data for the baseline lowerrestingresting ressure in millimetres of mercury. It is useful to state if LOSInformation relating to swallow-induced LOSrelaxation isessential, as assessed by the residual pressure during maximalLOS relaxation. The number and/or percentage of wet swal-lows accompanied by complete relaxation should be given. Oesophageal body: Measurements (eg. mean values +/-range) should be provided for the amplitude above the baseline. Values for the percentage of wet swallows Interpretation: meaningful summary should be pro-vided. There should be a manual review of any automatedreports with the aim of providing a clinically interpretableresult. A manometric diagnosis should be given where possi-ble, though it is important to emphasise that the finaldiagnostic formulation for an individual patient should bebased on a careful consideration of clinical features, radiolog-ical and/or endoscopic findings in addition to the manometricinformation. Quality radiological studies (standard bariumswallow or ÔmarshmallowÕ swallow) can provide importantinformation about bolus transit. reatment decisions shouldnot be based solely on manometric findings Evidencegrade: C ). 4.1 TECHNICAL ASPECTS OF AMBULATORY pH electrodes There are two forms of commercial pH electrode Ð antimonyand glass. Antimony electrodes are less expensive, of smallerdiameter and are better tolerated but have a shorter opera-tional life. Antimony

electrodes have been reported to driftmore during recordings and have a less linear response thanglass electrodes but appear adequate for clinical purposes.76,7776,77Prior to and following ambulatory oesophageal pH monitor-ing, a calibration using neutral and acidic buffers should beundertaken with appropriate temperature compensation toensure the electrode is responsive and has not drifted duringthe study by more than 0.5 pH units Evidence grade CEvidence grade C 7878woHealth and Clinical Excellence have recently approved wire-more expensive than catheter-based monitoring, asWireless pH monitoring is of obvious value in patients intol-erant of catheter-based monitoring but its wider clinical role Data loggers event marker for patients to record the occurrence of symp- Electrode positioning lower oesophageal sphincter, to prevent the electrode tem-pH step-up, fluoroscopy, endoscopic Evidence grade BEvidence grade B 84, 8584, 85 Restrictions prior to and during ambulatory oesophageal pH the day of the study.exclusion of the meal period from the analysis of the pH8686atients should therefore Duration of ambulatory oesophageal pH monitoring shorter recording periods. Unfortunately, published studies Evidence grade CEvidence grade C Reproducibility Intra-subject reproducibility of ambulatory oesophageal pH90909191abnormal total time oesophageal pHan individualÕs total time oesophageal pH Guidelines for oesophageal manometry and pH monitoring November 2006BSG Guidelines in Gastroenterology o9191imultaneous recordings from two pH electrodes positioned atthe same point in the oesophagus revealed surprising discrep-ancies, even to the point that two out of ten patients changedfrom having a normal to an abnormal total time oesophageal9292 4.2 INTERPRETATION OF OESOPHAGEAL PH DATA Criteria for acid reflux event aken to indicate acid reflux. Other pH thresholds have been Oesophageal pH monitoring variables poor reproducibility9191Òalk100100 Oesophageal pH monitoring variables in asymptomaticsubjects 9696ttempts have therefore been made to define physiolog-9696, it became apparent that pH Evidence grade BEvidence grade B Oesophageal pH monitoring variables in patients withoesophagitis owever, up to a quarter of patients with oesophagitis still Oesophageal pH monitoring variables in patients with acidreflux symptoms without oesophagitis is potentially more clinically relevant. However, although Analysis of symptoms before to the time the event marker on the data logger was Evidence grade BEvidence grade B 106106 Symptom index 108108, the value of the symptom index depends on Symptom sensitivity index The symptom sensitivity index was developed in an attemptto account for the limitations of the symptom index. It isdefined as the number of acid reflux episodes associated withsymptoms as a percentage of the total number of acid reflux109109109109 Symptom association probability Neither the symptom index nor the symptom sensitivityindex utilise all of the available data to determine the associ-ation of symptoms with acid reflux. The symptom associationprobability is a potentially useful statistical attempt to rectifythis. It is calculated by dividing the data

into two-minute sec-tions and determining whether acid reflux or symptoms110110Õmutations Ð symptom and reflux, symptom no reflux, refluxno symptom, no symptom or reflux Ð occurred by chance. A�symptom association probability of 95% is consideredpositive.Only the symptom index has been prospectively shown tobe of clinical value. A positive symptom index predicted aresponse to dose escalation in patients poorly responsive to111111 Keith Bodger and Nigel Trudgill BSG Guidelines in GastroenterologyNovember 2006 hown to predict a successful response to a proton pump112112113113esophagitis and a percentage total time oesophageal pHwithin the physiological range. 4.3 CLINICAL ROLE OF AMBULATORY OESOPHAGEAL PH re summarised in panel 3. Patients should be studied aftermonitoring is to exclude excess acid exposure. However, when Patients with heartburn or acid regurgitation endoscopy114114 Evidence grade BEvidence grade B Atherapeutic trialwith a proton pump inhibitor is cheapermore readily available than ambulatory oesophageal pH mon-115115of a proton pump inhibitor in patients with heartburn or acidregurgitation and no oesophagitis are difficult to compare dueto differences in trial design, drug dose, length of treatmentand patient population, some conclusions can be drawn. Highe.g. omeprazole 40mg BDe.g. omeprazole 40mg BDincreased sensitivity to more than 80% compared with abnor-116116117117improvement of at least 75% provided the highest sensitivity115115one-week high dose proton pump inhibitor trial in routineclinical practice without a placebo, in patients with heartburnor acid regurgitation and no oesophagitis, revealed 97% sensi-tivity compared with ambulatory oesophageal pH monitoring118118 Patients with heartburn or acid regurgitation refractory to Patients who continue to have heartburn or acid regurgitation Evidence grade CEvidence grade C the proton pump inhibitor119119espite continuing to take omeprazole 20mg BD during pH PATIENTS WITH CHEST PAIN, THROAT OR RESPIRATORY Chest pain with chest pain and unremarkable cardiac investigations have120-123120-123, many of the patientsen. However, given the costin all patients with chest pain and unremarkable cardiac Evidence grade CEvidence grade C proton pump inhibitor, to judge whether further dose escala-tion is appropriate. Patients should be studied while taking aproton pump inhibitor. Evidence grade CEvidence grade C Throat symptoms with a proton pump inhibitor127127However, ascribing throat symptoms and laryngeal abnor-considerable controversy. A study of asymptomatic volunteers129129wo placebo-controlled trials of a high dose pro-130,131130,131, pharyn- Guidelines for oesophageal manometry and pH monitoring November 2006BSG Guidelines in Gastroenterology INDICATIONS FOR AMBULATORY OESOPHAGEAL PH Patients with symptoms clinically suggestive of acidPatients with symptoms clinically suggestive of acid3)Patients with persistent acid gastro-oesophagealgradeC). eem appropriate to undertake a therapeutic trial of a proton Evidence grade CEvidence grade C onitoring off therapy may be of value to exclude excess acidgastro-oesophageal reflux when this appears unlikely or pH (Evidencerade C

) Respiratory symptoms monitoring with distal and proximal pH probes in patientsimprovements in symptom frequency136,137136,137,responded to a proton pump inhibitor136136Patients with a chronic cough, particularly with heartburn Evidence grade BEvidence grade B this appears unlikely or pH monitoring on a proton pump Evidence grade CEvidence grade C 141141atients with asthma should be managed, as patientswith chronic cough, if there is a clinical suspicion of GORD,to therapy, to judge whether further dose escalation is appro- Evidence grade CEvidence grade C eflux surgery abnormal total time oesophageal pH, if this is within theanti-reflux surgery144144atients with symptoms suggestive Evidence grade C) Patients with symptoms potentially due to acid reflux whoreflux surgery, since a poor response is an independentpredictor of a poor outcome following surgery144144 Evidence grade C) he pH study should be undertakenhile continuing to take a high dose proton pump inhibitorundertaken in patients with persistent heartburn or acidregurgitation following anti-reflux surgery, particularly if fur- Evidence grade C) 4.4 RECOMMENDATIONS FOR PH MONITORINGREPORTING General information The report should include patientidentification details, the date and timing of the test, and alist of current medications, in particular whether acid sup-pressing drugs were withdrawn or continued during thestudy. Oesophageal acid exposure percentage total timepH fo;&#xr 00;time pH Symptom analysis symptomatic events during the study. Evidence grade CEvidence grade C 5.0 CONTRAINDICATIONS TO OESOPHAGEAL tions. Patients with peptic strictures, oesophageal ulcers, Evidence Grade C ). 6.0 MORBIDITY, MORTALITY AND CONSENT Theoretically, intubation with a manometric catheter or pHinjury or bronchospasm. However, the occurrence and the fre- Keith Bodger and Nigel Trudgill BSG Guidelines in GastroenterologyNovember 2006 axis, as recommended in the British Society ofGastroenterology guidelines for antibiotic prophylaxis in gas-147147atients Evidence grade C) ll patients undergoing oesophageal manometry or ambu-latory oesophageal pH monitoring should give writteninformed consent Evidence grade CEvidence grade C This process shouldinclude discussion of the morbidity associated with the proce-dure and available alternative investigations. 6.0 GOVERNANCE ISSUES To ensure high clinical standards in oesophageal function Evidence grade CEvidence grade C Units undertaking oesophagealmanometry or pH monitoring should be regularly assessed byAGIP to ensure good clinical practice. 7.0 AUDIT The following topics are suggestions for audit:Minimum number of procedures per year within a unit per-forming oesophageal manometry and ambulatoryoesophageal pH monitoring should be 100 of each.Oesophageal manometry and pH monitoring reports shouldcontain the recommended minimum dataset.Clinicians undertaking oesophageal manometry and ambu-latory oesophageal pH monitoring should be registered withthe Association of Gastrointestinal Physiologists and theirunits assessed on a regular basis. 8.0 CONFLICTS OF INTEREST turers of proton pump inhibitors for speakerÕs fees. 9.0 ACKNOWLEDGMENTS oesophageal secti

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III wenty-four-hour esophageal III 124.Klauser AG, Heinrich C, Schindlbeck NE, et al. Is long term esophageal III 125.Fass R, Fennerty MB, Ofman JJ, et al. The clinical and economic value ofshort course of omeprazole in patients with noncardiac chest pain. IIb 126.Hanson DG, Conley D, Jiang J, et al. Role of esophageal pH recordingin management of chronic laryngitis: an overview. Ann Otol Rhinolaryngol 2000;109:4-9. V 27.Kamel PL, Hanson D, Kahrilas PJ. A prospective trial of omeprazole inhe treatment of posterior laryngitis. Am J Med 1994;96:321-326. II 128.Jacob P, Kahrilas PJ, Herzon G. Proximal esophageal pH-metry inpatients with Çreflux laryngitisÈ. Gastroenterology III 29.Hicks DM, Ours TM, Abelson TI, et al. The prevalence of hypopharynxindings associated with gastroesophageal reflux in normal volunteers. J II 130.Eherer AJ, Haberman W, Hammer HF, et al. Effect of pantoprazole onthe course of reflux-associated laryngitis: a placebo-controlled double-lind crossover study. Scand J Gastroenterol 2003;38:462-467. b 31.Vaezi MF, Richter JE, Stasney CR, et al. Tretament of chronic posterioraryngitis with esomeprazole. Laryngoscope 2006;116:254-260. b 132.Vaezi MF, Schroeder PL, Richter JE. Reproducibility of proximal probe pHparameters in 24-hour ambulatory esophageal pH monitoring. Am J III 33.Wo JM, Grist WJ, Gussack G, et al. Empiric trial of high Ð dosemeprazole in patients with posterior laryngitis: a prospective study. Am III 134.McGarvey LPA, Heaney LG, Lawson JT, et al. Evaluation and outcome ofiagnostic protocol. Thorax 1998;53:738-743. II 35.Irwin RS, Zawacki JK, Curley FJ, et al. Chronic cough as the solepresenting manifestation of gasrtoesophageal reflux. Am Rev Respir Dis III 136.Ours TM, Kavuru MS, Schilz RJ, et al. A prospective evaluation of Ib 137.Kiljander TO, Salomaa ERM, Hietanen EK, et al. Chronic cough and Ib 38.Avidan B, Sonnenberg A, Schnell TG, et al. Temporal associations III placebo-controlled cross-over study. Postgrad Med J 1994;70 Ib 140.Kiljander TO, Salomaa ER, Hietanen EK, et al. Gastroesophageal refluxin asthmatics: a double-blind, placebo-controlled crossover study with Ib 141.Harding SM, Richter JE, Guzzo MR, et al. Asthma and gastroesophagealreflux: acid suppressive therapy improves asthma outcome. Am J Med1996;100:395-405. III 142.Waring JP, Hunter JG, Oddsdottir M, et al. The preooperative evaluation III 143.Gotley DC, Smithers BM, Rhodes M, et al. Laparoscopic nissen III 144.Campos GMR, Peters JH, DeMeester T, et al. Multivariate analysis of III 145.Fass R, Hell R, Sampliner RE, et al. Effect of ambulatory 24-hour III results of 24-h ambulatory oesophageal pH monitoring. Eur J III 147.Antibiotic prophylaxis in gastrointestinal endoscopy. London: BritishSociety of Gastroenterology. 2001. IV Guidelines for oesophageal manometry and pH monitoring 11 November 2006BSG Guidelines in Gastroenterology These guidelines have been prepared by the British Society of GastroenterologyTheyrepresent a consensus of best practice based on the available evidence at the time ofpreparation. They may not apply in all situations and should be interpreted in the lightof specific clinical situations and resource availa