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Clasific de PCRE Segun Grado de Dificultad

Clasific de PCRE Segun Grado de Dificultad

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As for many medical procedures,ERCP outcomesare reported in terms of procedural success andcomplication rates.In general,technical successshould be defined on an intention-to-diagnose andintention-to-treat basis,and a consensus conferencehas standardized ERCP complication definitions.
Although technical success and complication dataare useful in assessing procedure quality,taken bythemselves they are relatively crude measures ofoutcome.A large multicenter prospective study by Freemanet al.
found that numerous patient-specific andendoscopist-specific factors significantly impact therisk of complications after biliary sphincterotomy.Similarly,technical success may vary markedlydepending on many factors,particularly the type ofintervention being attempted.When biliary sphinc-terotomy is attempted or when the goal is to removesingle small stones from the bile duct,for example,ERCP is almost always successful.
Extracting cal-culi from intrahepatic bile ducts or the pancreas,onthe other hand,is much more likely to result in atechnical failure.
Although interventional cardiologists have devel-oped a system to grade the technical difficulty ofcoronary artery lesions prior to angioplasty,
thereis presently no objective way to quantify ERCPdegree of difficulty.In an attempt to give technicalsuccess information from our center additional con-text,a relatively simple ERCP degree of difficultygrading scale was developed,pilot tested by apply-ing it retrospectively to our 1997 outcome data,andthen used to prospectively grade ERCPs at our cen-ter during 1998.
Demographic and procedural information for allERCPs done at our center is entered into a database(GITrac;Akron Systems Development,Charleston,S.C.)immediately after each procedure.In addition,all ERCPsperformed during the previous week are reviewed at anafternoon conference attended by a majority of gastroen-terology fellows and attending physicians at our center,aswell as a radiologist (R.A.) with expertise in ERCP inter-pretation.At this conference,technical success and com-plication determinations are made for each scheduled pro-cedure,and any additional details about earlier ERCPs(e.g.,late complications) are noted.Although patientswere not contacted routinely after ERCP to capture com-plications,it is unlikely that they would have occurred
Grading ERCPs by degree of difficulty:a new concept toproduce more meaningful outcome data
Stephen M.Schutz,MD,Robert M.Abbott,MD
San Antonio, Texas 
Simple endoscopic retrograde cholangiopancreatography (ERCP) outcome mea-sures such as success and complication rates may not allow direct comparisons among endos-copists or centers because procedure degree of difficulty can vary tremendously from case tocase.We propose a new grading scale designed to objectively quantify ERCP degree of difficulty.
A 1 to 5 scale was devised to grade ERCPs according to their level of technical difficulty.A retrospective pilot study was performed to assess ERCP outcomes at our institution accordingto difficulty grade.The scale was then prospectively applied to all ERCPs during a 1-year period.
In the pilot study,209 of 231 (90%) ERCPs were technically successful,and 8 (3%) werefollowed by complications.Grade 1 to 4 procedures were more likely to succeed (94% vs.74%,
< 0.05) and less likely to have associated complications (2% vs.10%,
< 0.05) than grade 5/5BERCPs.Of 187 ERCPs assessed prospectively,166 (89%) were successful and 10 (5%) were fol-lowed by complications;132 of 138 (96%) grade 1 to 4 procedures succeeded compared with 30of 46 grade 5 to 5B ERCPs (65%,
< 0.001),but complications were not significantly more frequentin grade 5 to 5B ERCPs (8.7% vs.4.3%,
= not significant).
Technical success was dependent on ERCP degree of difficulty,but complicationswere not.Outcome data that incorporate degree of difficulty information may be more meaningful,allowing endoscopist-to-endoscopist and center-to-center comparisons.(Gastrointest Endosc2000;51:535-9.)
Received May 25,1999.For revision August 30,1999.AccepteDecember 9,1999.From the Departments of Gastroenterology and Radiology,Wilford Hall Medical Center,San Antonio,Texas.Presented in part at the annual ASGE meeting May 18,1999,Orlando,Florida.Reprint requests:Stephen M.Schutz,MD,Chief,Division oGastroenterology,David Grant Medical Center,101 Bodin Ci,Travis AFB,CA 94535.
without our knowledge because we operate in a closed sys-tem.Technical success is determined on an intention-to-diagnose and intention-to-treat basis,and complicationsare defined according to published criteria.
Any differ-ences of opinion are discussed,and a final determinationis arrived at by consensus.In late 1997,one of the authors with advanced trainingand interest in ERCP (S.M.S.) developed a 1 to 5 ERCPdegree of difficulty grading scale (Table 1).If an ERCPwas previously unsuccessful,it was given a “Bmodifier(e.g.,a diagnostic cholangiogram that was unsuccessful atanother center was a grade 1B).As part of a pilot study,this scale was applied retroactively to ERCPs performedduring calendar year 1997,which were reviewed andassigned a difficulty grade based on the type of interven-tion performed,if any.Procedures involving more thanone intervention received the highest applicable gradebased on procedure intent (e.g.,an ERCP that involved abiliary sphincterotomy and pancreatic stent insertionwould be a grade 5 procedure.If the sphincterotomy suc-ceeded and stent insertion was unsuccessful,this wouldbe graded as a failed grade 5 procedure).After analysis of the retrospective 1997 data,our scalewas applied to individual ERCPs prospectively,beginningwith the first ERCP conference in January 1998.As notedabove,ERCP technical success is assessed at our weeklyconference based on the intent of the procedure,which isusually,but not always,known before the procedure.Forexample,the intent of an endoscopist faced with a jaun-diced elderly patient with CT-proven dilated bile ductsand a pancreatic mass is to place a biliary stent,even if heor she is unable to reach the papilla due to duodenal com-pression.Conversely,the intent of an endoscopist per-forming ERCP to evaluate presumed pancreatic pain,whothen finds bile duct stones and a normal pancreatogram,is to remove the stones.)In both the retrospective and prospective studies,grades 1 to 4B and 5 to 5B ERCPs were compared to assessdifferences in technical success.These groups were select-ed for comparison because all endoscopists performingERCP should be able to do grade 1 to 4 ERCPs,whereasgrade 5 to 5B procedures may be more appropriate forexpert endoscopists.Grades 1 to 4B and 5 to 5B procedureswere compared using the Fisher exact test,and
values of< 0.05 were considered to be statistically significant.
RESULTSRetrospective pilot study
In 1997 our unit performed 231 ERCPs;192(83%) were grade 1 to 4 procedures,and 39 (17%)were grade 5 or 5B (Table 2).Analysis of outcomesrevealed a technical success rate for grade 1 to 4BERCPs of 94%(180 of 192 procedures) but only 74%(29 of 39 ERCPs) for grade 5 and 5B cases (
=0.028,Fisher exact test).Grade 5 and 5B ERCPswere also more likely to be associated with compli-cations than those of grades 1 to 4B (10%vs.2%,
= 0.028,Fisher exact test).
Prospective study
We performed 187 ERCPs in 1998 (Table 3);166(89%) were technically successful.Failed proceduresincluded grade 1,diagnostic cholangiogram/pancre-atogram (n = 3);grade 1B,diagnostic pancreatogram(n = 1);grade 4,biliary sphincterotomy (succeeded)plus removal of cystic duct stones (failed) (n = 1);grade 5,common duct biliary stent status post-1Billroth II gastrectomy (n = 1),precut for biliaryaccess (n = 2),mechanical lithotripsy of bile ductstone (n = 1),pancreatic duct sphincterotomy plusstent insertion (n = 2),pancreatic duct stent place-ment (n = 1);grade 5B,cystic duct stricture dilationplus stent placement via cholecystoduodenostomy(n = 1),pancreatic duct sphincterotomy plus stent
S Schutz,R AbbottGrading ERCPs by degree of difficulty,more meaningful outcome dat
Table 1.Summary of ERCP degree of difficulty grading scale
Biliary proceduresPancreatic proceduresGrade 1:simple diagnostic ERCPStandard diagnostic cholangiogramStandard diagnostic pancreatogramGrade 2:simple therapeutic ERCP Standard biliary sphincterotomy;removalNot applicableof 1-2 small common duct stones (
1 cm);nasobiliary drain placementGrade 3:complex diagnostic ERCPDiagnostic cholangiogram,Billroth IIDiagnostic pancreatogram,Billroth II anatomy;anatomy;biliary cytologyminor papilla cannulation;pancreatic cytologyGrade 4:complex therapeutic ERCPMultiple (
3) or large (> 1 cm) commonNot applicableduct stones;cystic duct or gallbladderstone removal;common duct stricturedilation;common duct stenting(plastic or metal)Grade 5:very advanced ERCPPrecut biliary sphincterotomy;stone removal All pancreatic therapy (pancreatic sphincterotomy,with lithotripsy (any type);intrahepatic stenting,stricture dilation,or stone removal,stone removal;intrahepatic stricture any minor papilla therapy);any pseudocystdilation;biliary therapy,Billroth II anatomy;drainage (transpapillary,transgastric,cholangioscopytransduodenal);pancreatoscopyIf an ERCP was previously unsuccessful,it was given a B modifier.
insertion (n = 2),pancreatic duct stricture dilationplus stent placement (n = 1),minor papilla stentplus sphincterotomy (n = 2),transpapillary pseudo-cyst drainage (n = 2),pancreatoscopy/pancreaticduct stone laser lithotripsy (n = 1).Ten of 187 ERCPs (5%) were associated with com-plications:grade 1,1 moderate pancreatitis;grade 2,1 severe bleeding,1 mild pancreatitis,1 mild cholan-gitis;grade 3,1 mild cholangitis;grade 4,1 mildcholangitis;grade 5,1 mild fever,1 mild pancreati-tis;and grade 5B,1 moderate pancreatitis,1 moder-ate infection (candidal infection of a pseudocyst fol-lowing a failed attempt at transpapillary drainage).Thirty-five percent of grade 5 to 5B ERCPs wereunsuccessful (16 of 46),compared with only 4%ofgrade 1 to 4 procedures (5 of 138,
< 0.001).However,complications were not significantly morefrequent in grade 5 to 5B ERCPs (8.7%vs.4.3%,
=not significant).
Currently,standardized means of assessingpatient illness such as the American Society ofAnesthesiology (ASA) scores are widely used to esti-mate risk of some procedure complications.In addi-tion,Fleischer et al.
have developed an inventivesystem for classifying and grading such complica-tions by quantifying their negative repercussions.However,there is presently no objective way to putERCP technical failures into perspective by quanti-fying procedural degree of difficulty.Practitioners ofcoronary angioplasty have utilized a lesion-specificgrading scale to objectively estimate technical diffi-culty for many years.
In this system,Alesions areminimally difficult (expected technical success rate85%or greater),“B”stenoses are moderately com-plex (expected success rate 60%to 85%),and “Clesions are very challenging (expected success rateless than 60%).Similarly,our system uses an easilyunderstandable 1 to 5 scale to quantify ERCPdegree of difficulty in a way that we believe mini-mizes bias due to varying skill levels of individualendoscopists.Our grading scale does not directly address thefact that some grade 1 or 2 ERCPs are much moredifficult than those with a higher grade.In fact,although our retrospective data from 1997 show that grade 5 to 5B ERCPs carry a higher rate oftechnical failure than lower grade procedures,wealso saw proportionately (but not significantly) morefailures in grades 1 and 3 than grades 2 and 4.Ourstudy sample is relatively small,though,and theprocedure outcomes reported reflect the capabilitiesof a single center.It is our belief that this scale willreveal sequentially higher technical failure rateswith increasing procedure grades when large num-bers of ERCPs are analyzed,particularly if the pro-cedures are performed at a variety of centers by aspectrum of endoscopists.However,further studywould be needed to substantiate this hypothesis.
Grading ERCPs by degree of difficulty,more meaningful outcome dataS Schutz,R AbbotVOLUME 51,NO.5,2000GASTROINTESTINAL ENDOSCOP
Table 2.Retrospective ERCP outcomes by difficulty grade (January 1,1997-December 31,1997)
N (%)Technical success (%)Complications (%)Grade 1106 (46%)98 (92%)3 (3%)Grade 1B2 (1%)1 (50%)0 (0%)Grade 235 (15%)35 (100%)0 (0%)Grade 35 (2%)4 (80%)1 (20%)Grade 442 (18%)40 (95%)0 (0%)Grade 4B2 (1%)2 (100%)0 (0%)Grade 532 (14%)27 (84%)3 (9%)Grade 5B7 (3%)2 (28%)1 (17%)Total231(209 (90%)8 (3%)
Table 3.Prospective ERCP outcomes by difficulty grade (January 1,1998-December 31,1998)
N (%)Technical success (%)Complications (%)Grade 168 (36.5%)65 (96%)1 (1.5%)Grade 1B1 (0.5%)0 (0%)0 (0%)Grade 233 (18%)33 (100%)3 (10%)Grade 36 (3%)6 (100%)1 (17%)Grade 432 (17%)31 (97%)1 (3%)Grade 535 (18%)28 (79%)2 (6%)Grade 5B12 (7%)3 (25%)2 (17%)Total187166 (89%)10 (5%)

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