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Standards of Practice

Quality Improvement Guidelines forPercutaneous TranshepaticCholangiography, Biliary Drainage, andPercutaneous CholecystostomyWael E. A. Saad, MD, Michael J. Wallace, MD, Joan C. Wojak, MD, Sanjoy Kundu, MD, and

John F. Cardella, MD

J Vasc Interv Radiol 2010; 21:789 –795

PREAMBLE

THE membership of the Society of In-terventional Radiology (SIR) Stan-dards of Practice Committee representsexperts in a broad spectrum of interven-tional procedures from both the privateand academic sectors of medicine. Gen-erally Standards of Practice Committeemembers dedicate the vast majority oftheir professional time to performing in-terventional procedures; as such theyrepresent a valid broad expert constit-uency of the subject matter underconsideration for standards produc-tion.

From the Division of Vascular Interventional Radi-ology, Department of Radiology (W.E.A.S.), Univer-sity of Virginia Health System, Charlottesville, Vir-ginia; Department of Radiology (M.J.W.), TheUniversity of Texas M. D. Anderson Cancer Center,Houston, Texas; Department of Radiology (J.C.W.),Our Lady of Lourdes Medical Center, Lafayette,Louisiana; Department of Medical Imaging (S.K.),Scarborough General Hospital, Scarborough, On-tario, Canada; and Department of Radiology (J.F.C.),Geisinger Health System, Danville, Pennsylvania.Received December 15, 2009; final revision receivedJanuary 3, 2010; accepted January 13, 2010. Addresscorrespondence to W.E.A.S., c/o Debbie Katsarelis,SIR, 3975 Fair Ridge Dr., Suite 400 N., Fairfax, VA22033 E-mail: [emailprotected]

M.J.W. has received research funding from SiemensMedical Solutions (Iselin, New Jersey). None of theother authors have identified a conflict of interest.

An earlier version of this article appeared in J VascInterv Radiol 1997; 8:677–681; and was reprinted inJ Vasc Interv Radiol 2003; 14(Suppl):S243–S246.

© SIR, 2010

DOI: 10.1016/j.jvir.2010.01.012

Technical documents specifying theexact consensus and literature reviewmethodologies as well as the institu-tional affiliations and professional cre-dentials of the authors of this docu-ment are available upon request fromSIR, 3975 Fair Ridge Dr., Suite 400 N.,Fairfax, VA 22033.

METHODOLOGY

SIR produces its Standards of Prac-tice documents using the followingprocess. Standards documents of rele-vance and timeliness are conceptual-ized by the Standards of Practice Com-mittee members. A recognized expertis identified to serve as the principalauthor for the standard. Additionalauthors may be assigned dependentupon the magnitude of the project.

An in-depth literature search is per-formed using electronic medical liter-ature databases. Then a critical reviewof peer-reviewed articles is performedwith regards to the study methodol-ogy, results, and conclusions. Thequalitative weight of these articles isassembled into an evidence table,which is used to write the documentsuch that it contains evidence-baseddata with respect to content, rates, andthresholds.

When the evidence of literature isweak, conflicting, or contradictory,consensus for the parameter is reachedby a minimum of 12 Standards ofPractice Committee members using a

modified Delphi consensus method

(Appendix A). For purposes of thesedocuments consensus is defined as80% Delphi participant agreement ona value or parameter.

The draft document is critically re-viewed by the Revisions Subcommitteemembers of the Standards of PracticeCommittee, either by telephone confer-ence calling or face-to-face meeting. Thefinalized draft from the Committee issent to the SIR membership for furtherinput/criticism during a 30-day com-ment period. These comments are dis-cussed by the Subcommittee, and ap-propriate revisions made to create thefinished standards document. Prior toits publication the document is en-dorsed by the SIR Executive Council.

INTRODUCTION

Percutaneous transhepatic cholan-giography is a safe and effective tech-nique for evaluating biliary abnormal-ities. It reliably demonstrates the levelof abnormalities and sometimes canhelp diagnose their etiologies. Percuta-neous transhepatic biliary drainage is aneffective method for the primary or pal-liative treatment of many biliary abnor-malities demonstrated with cholangiog-raphy. Percutaneous cholecystostomy isan effective method for decompressingthe gallbladder for managing cholecys-titis either definitively or as a temporiz-ing measure before cholecystectomy.

These guidelines are written to beused in quality improvement pro-

grams to assess percutaneous transhe-

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790 • QI Guidelines: Cholangiography, Biliary Drainage, Cholecystostomy June 2010 JVIR

patic cholangiography, biliary drain-age, and cholecystostomy. The mostimportant processes of care are (i) pa-tient selection, (ii) performing the proce-dure, and (iii) monitoring the patient.The outcome measures or indicatorsfor these processes are indications,success rates, and complication rates.Outcome measures are assigned thresh-old levels.

DEFINITIONS

Percutaneous transhepatic cholan-giography is a diagnostic procedure thatinvolves the sterile placement of a small-gauge needle into peripheral biliaryradicles with use of imaging guidance,followed by contrast material injectionto delineate biliary anatomy and poten-tial biliary pathologic processes. Thefindings are documented on radio-graphs obtained in multiple projec-tions. Percutaneous transhepatic biliarydrainage is a therapeutic procedurethat includes the sterile cannulationof a peripheral biliary radicle afterpercutaneous puncture followed byimaging-guided wire and catheter ma-nipulation. Placement of a tube or stentfor external and/or internal drainagecompletes the procedure. Percutaneoustherapy of biliary lesions is often staged,requiring several sessions to achieve thetherapeutic goals. Percutaneous chole-cystostomy is a therapeutic procedurethat involves the sterile placement of aneedle into the gallbladder with use ofimaging guidance to aspirate bile. Thisis commonly followed by sterile place-ment of a tube for external drainage ofgallbladder contents, which completesthe procedure.

Successful percutaneous transhe-patic cholangiography is defined assufficient needle localization and con-trast material opacification to allowimage-based diagnosis or planning oftreatment. Successful biliary drainageor cholecystostomy is defined as theplacement of a tube or stent with useof imaging guidance to provide con-tinuous drainage of bile.

Complications can be stratified onthe basis of outcome. Major complica-tions result in admission to a hospitalfor therapy (for outpatient proce-dures), an unplanned increase in thelevel of care, prolonged hospitaliza-tion, permanent adverse sequelae, ordeath. Minor complications result in

no sequelae; they may require nominal

therapy or a short hospital stay forobservation (generally overnight; seeAppendix B). The complication ratesand thresholds described herein referto major complications unless other-wise specified.

INDICATIONS ANDCONTRAINDICATIONS

Indications for percutaneous transhe-patic cholangiography, percutaneoustranshepatic biliary drainage, and chole-cystostomy are listed in Tables 1–3, re-spectively (1–27). The threshold for

Table 1Percutaneous TranshepaticCholangiography: Indications (1–6)

Define level of obstruction in patientswith dilated bile ducts

Evaluate for presence of suspectedbile duct stones

Determine etiology of cholangitisEvaluate suspected bile duct

inflammatory disordersDemonstrate site of bile duct leakDetermine etiology of transplanted

hepatic graft dysfunction

Table 2Percutaneous Transhepatic BiliaryDrainage: Indications (7–10)

Provide adequate biliary drainageDecompress obstructed biliary treeDivert bile from and place stent in

bile duct defectProvide a portal of access to the biliary

tract for therapeutic purposes thatinclude but are not limited to

Dilate biliary stricturesRemove bile duct stonesStent malignant lesionsBrachytherapy/phototherapyEndoluminal tissue sample or

foreign body retrievalProvide a portal of access to the biliary

tract for mid- to long-termdiagnostic purposes (lower-riskcholangiography*)

*Cholangiography from anindwelling percutaneous biliary drainsite is probably a lower-riskcholangiography procedure thanrepetitive de novo percutaneoustranshepatic cholangiography withthe use of needles.

these indications is 95%. When fewer

than 95% of procedures are for theseindications, the department will reviewthe process of patient selection.

Currently, metal stents are used almostexclusively for malignant disease. How-ever, the committee recognizes that cov-ered metal stent (or stent-graft) placementfor benign strictures with the intent ofsubsequent retrieval is a potentially newindication, although the results of this arestill inconclusive.

Gallbladder decompression for themanagement of cholecystitis can be per-formed with the intent of definitivetherapy in patients at high risk withmedical comorbidities or as a tempo-rizing measure augmenting medicaltreatment and preceding a subse-quent, more elective, cholecystec-tomy. The decision of whether toproceed with cholecystectomy (in asurgical candidate) or consider per-cutaneous cholecystostomy a defini-tive measure (in a nonsurgical candi-date) is usually multidisciplinary (ie,surgical, anesthesiology, and radiology)and depends on patients’ response totherapy.

Coagulopathy is a relative contrain-dication to percutaneous transhepaticcholangiography, biliary drainage, andpercutaneous cholecystostomy. Everyeffort should be made to correct or im-prove coagulopathy before the proce-dure. In patients with persistent coagu-lopathy, these procedures may still be

Table 3Percutaneous Cholecystostomy:Indications (11–27)

Gallbladder access (�95%)*Management of cholecystitisPortal for dissolution/removal of

stonesBiliary tract access (�5%)*

Decompress obstructed biliary tractDivert bile from bile duct defectProvide a portal of access to the

biliary tract for therapeuticpurposes (see Table 2)

*The thresholds for gallbladder andtranscholecystic biliary tract access are95% and 5%, respectively. When thisratio for these indications is different,the department will review the processof patient selection. The first-line routefor percutaneous biliary tract access isthe transhepatic route and not thetranscholecystic route.

indicated if they are associated with a

e A

Saad et al • 791Volume 21 Number 6

lower expected morbidity rate than al-ternative methods of diagnosis or treat-ment.

QUALITY IMPROVEMENT

Although practicing physicians shouldstrive to achieve perfect outcomes (eg,100% success, 0% complications), inpractice all physicians will fall short ofthis ideal to a variable extent. Thus, in-dicator thresholds may be used to assessthe efficacy of ongoing quality improve-ment programs. For the purposes ofthese guidelines, a threshold is a specificlevel of an indicator that should prompta review. “Procedure thresholds” or“overall thresholds” reference a groupof indicators for a procedure (eg, majorcomplications). Individual complicationsmay also be associated with complication-specific thresholds. When measures suchas indications or success rates fall belowa minimum threshold or when compli-cation rates exceed a maximum thresh-old, a review should be performed todetermine causes and to implementchanges, if necessary. For example, if theincidence of sepsis is one measure of thequality of percutaneous transhepaticcholangiography, values in excess of thedefined threshold should trigger a re-view of policies and procedures withinthe department to determine the causesand to implement changes to lower theincidence for the complication. Thresh-olds may vary from those listed here; forexample, patient referral patterns andselection factors may dictate a differentthreshold value for a particular indica-tor at a particular institution. Thus, set-ting universal thresholds is very diffi-cult, and each department is urged toalter the thresholds as needed to in-crease or decrease values to meet itsown quality improvement programneeds.

Participation by the radiologist in pa-tient follow-up is an integral part of per-cutaneous transhepatic cholangiography,

Table 4Percutaneous TranshepaticCholangiography: Success Rates (1–4)

Outcome Threshold (%)

Opacify dilated ducts 95Opacify nondilated

ducts65

biliary drainage, and cholecystostomy

and will increase the success rate of theprocedure. Close follow-up, with moni-toring and management of patients whohave undergone percutaneous transhe-patic cholangiography, biliary drainage,and cholecystostomy, is appropriate forthe radiologist.

SUCCESS RATES ANDTHRESHOLDS

Success rates for percutaneous tran-shepatic cholangiography, percutane-ous transhepatic biliary drainage,

Table 5Percutaneous Transhepatic Biliary Drain

Outcome

Procedural success after opacification byCannulation

Dilated ductsNondilated ducts

Internal drainage (tube or stent)Stone removal (9,34)

Patency successStricture dilation (benign)

Sclerosing cholangitis (35–37)Other (35,38–41)Palliative stents for malignant diseas

Note.—PTC � percutaneous transhepatic*Among successful cannulations.†Consensus for threshold not reached (se

Table 6Percutaneous Cholecystostomy: Success

Outcome

Procedural success for aspiration of gallbTechnical success*

21-gauge needle18-gauge needle

Clinical success†Single aspirationMultiple (n � 2–3) aspirations

Procedural success for cholecystostomy dTechnical successIntent-to-treat clinical success†

Cholecystostomy as definitive treatmenmorbidity)

With cholecystectomy or repeat cholecyneeded

Cholecystostomy for acalculous cholecyCholecystostomy for calculous cholecys

*Greater than 95% of failures resulted frogallbladder under image guidance (19,42–†Clinical success based on reduction of preactive protein (19,42–59).

and percutaneous cholecystostomy are

listed in Tables 4 – 6, respectively (1–4,9,19,28 –59).

Clinical success rate of cholecystos-tomy in a particular practice dependson patient selection. Patients’ comor-bidity, the proportion of patients withcholelithiasis, and whether the prepro-cedural diagnosis of cholecystitis iscorrect affect results. Having a lowthreshold for diagnosing cholecystitisin inpatients potentially increases therate of false positive cholecystitis, andin turn this reduces the success rateof cholecystostomy. Positive microbial

e: Success Rates (9,28–41)

Threshold (%)

957090*90

††

8–33) 50 (at 6 mo)

olangiography.

ppendix A).

tes (19,42–59)

Threshold (%)

der contents (19,42–44)

8095

5080

n placement (45–59)9065

the sick (high risk of

stomy resorted to as 75

tis 65s 75

thick aspirate and not failure to access)., fever, white blood cell count, and C-

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792 • QI Guidelines: Cholangiography, Biliary Drainage, Cholecystostomy June 2010 JVIR

been reported in between 40% and80% of cases (12,14,18,52,54,55,58–61).

COMPLICATION RATES

Percutaneous TranshepaticCholangiography

When 21-gauge or smaller needlesare used, the major and minor compli-cations of percutaneous transhepaticcholangiography should be low. Allpatients should be treated with appro-priate antibiotics before needle punc-ture (1–4,62,63). Complication ratesare listed in Table 7.

Percutaneous Transhepatic BiliaryDrainage

The complication rate for transhepaticbiliary drainage can be substantial, andvaries with preprocedure patient statusand diagnosis (Table 8) (10,28–30,32,33,64–66). Patients with coagulopathies,cholangitis, stones, malignant obstruc-tion, or proximal obstruction will havehigher complication rates (9,32,65,67,68).Several authors have suggested thatcomplications related to internal/ex-ternal tubes as a result of inadequatebile flow and tube dislodgment (sepsisand hemorrhage) can be minimized byplacing a self-retaining tube of at least10 F through the ampulla or anasto-mosis (8,10,64). All patients should betreated with appropriate antibioticsbefore initiating the procedures tominimize septic complications (62,63).The duration of antibiotic therapy af-ter the procedures will be determinedby the clinical course of individual pa-tients.

Published rates for individual typesof complications are highly dependenton patient selection and are based onseries comprising several hundred pa-tients, which is a volume larger thanmost individual practitioners are likelyto treat. Therefore, we recommend thatcomplication-specific thresholds be setat twice the complication-specific rateslisted in Table 8. It is also recognizedthat a single complication can cause arate to cross above a complication-spe-cific threshold when the complicationoccurs in a small volume of patients (eg,early in a quality improvement pro-gram). In this situation, the overall pro-cedure threshold is more appropriatefor use in a quality improvement pro-

gram. The recommended overall proce-

dure threshold for all major complicationsof percutaneous transhepatic biliarydrainage is 10%.

Percutaneous Cholecystostomy

The complication rate for percuta-neous cholecystostomy varies withpreprocedure patient status (Table 9)(11–19,42,46 –50,52,54,58,59). All pa-tients should be treated with appro-priate antibiotics, and the duration ofantibiotic therapy after the procedure

Table 7Percutaneous Transhepatic Cholangiogra

Major Complication

Sepsis, cholangitis, bile leak, hemorrhageor pneumothorax

Table 8Percutaneous Transhepatic Biliary Drain(10,28–30,32–33,64–66)

Major Complication

IntraproceduralSepsisHemorrhageInflammatory/infectious (abscess, perit

cholecystitis, pancreatitis)PleuralDeath

PostproceduralInadvertent catheter discontinuation re

novo PTC, death and/or surgery

Note.—PTC � percutaneous transhepatic*There is no clear consensus in the literatHowever, it is a recognized postprocedur

Table 9Percutaneous Cholecystostomy: Major C

Major Complication

IntraproceduralSepsisHemorrhageInflammatory/infectious (abscess, peritTransgression of adjacent structures (co

small bowel, pleura)Death

PostproceduralInadvertent catheter discontinuation re

de novo cholecystostomy, death and/surgery

will be determined by the clinical

course of individual patients. Pub-lished rates for individual types ofcomplications are highly dependenton patient selection and are based onseries comprising tens of patients,which is a volume larger than mostindividual practitioners are likely totreat. Therefore, we recommend thatcomplication-specific thresholds be setat twice the complication-specific rateslisted in Table 9. It is also recognizedthat a single complication can cause arate to cross above a complication-spe-

y: Major Complications

ReportedRate (%)

Suggested ProcedureThreshold (%)

2 4

e: Major Complications

ReportedRate (%)

Suggested SpecificThreshold (%)

2.5 52.5 5

tis, 1.2 5

0.5 21.7 3

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olangiography.on the rate of this complication.omplication.

plications (11–19,42,46–50,52,54,58–59)

ReportedRate (%)

Suggested SpecificThreshold (%)

2.5 52.2 5

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Saad et al • 793Volume 21 Number 6

occurs in a small volume of patients(eg, early in a quality improvementprogram). In this situation, the overallprocedure threshold is more appropri-ate for use in a quality improvementprogram. The recommended overallprocedure threshold for all major compli-cations of percutaneous cholecystostomyis 5% (sequelae of catheter dislodgmentnot included). The 30-day postproceduralmortality rate depends on patient selec-tion/referral patterns and has a widerange (8%–36%) depending on the popu-lation presented (13,15,18,47,53,54,57). Thevast majority of 30-day mortality cases arerelated to patient comorbidities and notdirectly a cause of the procedure.

Published rates for individual typesof complications are highly depen-dent on patient selection and arebased on series comprising severalhundred patients, which is a largervolume than most individual practi-tioners are likely to treat. Generallythe complication-specific thresholdsshould be set higher than the compli-cation-specific reported rates listedhere. It is also recognized that a singlecomplication can cause a rate to crossabove a complication-specific thresh-old when the complication occurswithin a small patient series (eg, earlyin a quality improvement program). Inthis situation, an overall proceduralthreshold is more appropriate for usein a quality improvement program. InTable 9, all values are supported bythe weight of literature evidence andpanel consensus.

Acknowledgments: Wael E. A. Saad,MD, authored the first draft of this reviseddocument and served as topic leader dur-ing the subsequent revisions of the draft.Sanjoy Kundu, MD, is chair of the SIR Stan-dards of Practice Committee and MichaelWallace, MD, is the chair of the SIR Revi-sions Subcommittee. John F. Cardella, MD,is Councilor of the SIR Standards Division.Other members of the Standards of Prac-tice Committee and SIR who participatedin the development of this revised clinicalpractice guideline are (listed alphabetical-ly): John F. Angle, MD, Daniel B. Brown,MD, Horacio R. D’Agostino, MD, SanjeevaP. Kalva, MD, Arshad Ahmed Khan,MD, Cindy Kaiser Saiter, NP, Marc S.Schwartzberg, MD, Samir S. Shah, MD,Nasir H. Siddiqi, MD, LeAnn Stokes,MD, Richard B. Towbin, MD, AradhanaVenkatesan, MD, and Darryl A. Zucker-

man, MD.

APPENDIX A: CONSENSUSMETHODOLOGY

Reported complication-specific rates insome cases reflect the aggregate of ma-jor and minor complications. Thresh-olds are derived from critical evaluationof the literature, evaluation of empiricaldata from Standards of Practice Com-mittee members’ practices, and, whenavailable, the SIR HI-IQ System nationaldatabase.

Consensus on statements in thisdocument was obtained utilizing amodified Delphi technique (1,2).

The Committee was unable to reachconsensus on (i) the patency rate orthreshold for dilation of stricturescaused by sclerosing cholangitis andthe (ii) patency rate or thresholdfor dilation of benign strictures notcaused by sclerosing cholangitis. Thefailure to reach consensus was a resultof limited reported data and lack ofa*greement between reported data andthe experiences of the committeemembers.

References1. Fink A, Kosefcoff J, Chassin M, Brook

RH. Consensus methods: characteris-tics and guidelines for use. Am J PublicHealth 1984; 74:979–983.

2. Leape LL, Hilborne LH, Park RE, et al.The appropriateness of use of coronaryartery bypass graft surgery in New YorkState. JAMA 1993; 269:753–760.

APPENDIX B: SIRSTANDARDS OF PRACTICECOMMITTEECLASSIFICATION OFCOMPLICATIONS BYOUTCOME

Minor Complications

A. No therapy, no consequence.

B. Nominal therapy, no consequence;includes overnight admission forobservation only.

Major Complications

C. Require therapy, minor hospital-ization (�48 hours).

D. Require major therapy, unplannedincrease in level of care, prolongedhospitalization (�48 hours).

E. Permanent adverse sequelae.

F. Death.

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SIR DISCLAIMER

The clinical practice guidelines of the Society of Interventional Radiology attempt to define practice principles thatgenerally should assist in producing high quality medical care. These guidelines are voluntary and are not rules. Aphysician may deviate from these guidelines, as necessitated by the individual patient and available resources. Thesepractice guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of carethat are reasonably directed towards the same result. Other sources of information may be used in conjunction withthese principles to produce a process leading to high quality medical care. The ultimate judgment regarding theconduct of any specific procedure or course of management must be made by the physician, who should consider allcirc*mstances relevant to the individual clinical situation. Adherence to the SIR Quality Improvement Program will notassure a successful outcome in every situation. It is prudent to document the rationale for any deviation from thesuggested practice guidelines in the department policies and procedure manual or in the patient’s medical record.