title: Routine versus selective intra-operative cholangiography during laparoscopic cholecystectomy A method for assessing the quality of a randomized control trial. Open Cholecystectomy A Contemporary Analysis of 42,474 Patients Value and Consequences of Routine Intraoperative Cholangiography During Cholecystectomy Does routine intraoperative cholangiography prevent bile duct transection? Prospective evaluation of a selective approach to cholangiography for suspected common bile duct stones. Methods for combining randomized clinical trials: strengths and limitations. Does selective peroperative cholangiography result in missed common bile duct stones? Incidence, Risk Factors, and Prevention of Biliary Tract Injuries during Laparoscopic Cholecystectomy in Switzerland [Intraoperative cholangiography as a routine method? A prospective, controlled, randomized study]. Routine cholangiography is not warranted during laparoscopic cholecystectomy. Consequences of routine peroperative cholangiography during cholecystectomy for gallstone disease: A prospective, randomized study
abstract: Opinion is divided whether intra-operative cholangiography should be performed routinely or on a selective basis during laparoscopic cholecystectomy . We therefore performed the first prospect i ve r and omized trial of static cholangiography in patients who did not have indications for cholangiograms .  Laparoscopic cholecystectomy  was attempted on 164 consecutive patients , of whom 49 ( 30 % ) patients were excluded from the trial due to indications for or against cholangiography .  In the remaining 115 ( 70 % ) patients , 56 were r and omized to the cholangiography group while 59 patients did not receive cholangiograms .  Duration of postoperative hospitalization and interval to return to full activity were identical in the two groups . Static cholangiograms added 16 ± 1 min ( mean ± SEM ) to the procedures ( p<0.01 ) . Cholangiography  increased the total charges for the operation by almost $ 700 ( p<0.01 ) . Cholangiograms were performed successfully in 94.6 % of the patients and changed the operative management in 4 ( 7.5 % ) patients . There was 1 ( 1.9 % ) false negative study . Intra-operative cholangiography did not reveal aberrant bile ducts at risk of injury from the operative dissection . There was no mortality or cholangiogram-related morbidity in either group . In follow-up ranging from 2–12 months , there has been no clinical evidence of bile duct injury or retained common bile duct stones . In summary , in patients without indications for cholangiography , the performance of static cholangiograms markedly increased the operative time and cost of laparoscopic cholecystectomy  . The operative management of a minority of patients was changed by the information obtained , but laparoscopic cholecystectomy may be performed safely in the absence of cholangiograms with little risk of injury to the major ductal system or retained calculi . RésuméLes avis sont partagés quant à la pratique systématique , ou seulement élective , d'une cholangiographie lors de la cholécystectomie coelioscopique . Nous avons mené le premier essai r and omisé prospect if de cholangiographie peropératoire chez des patients n'ayant pas d'indication formelle de cholangiographie . Dans une série de 164 cholécystectomies coelioscopiques consécutives , 49 patients ( 30 % ) ont été éliminés de l'étude parce qu'il existait une indication ou une contreindication formelles à la cholangiographie peropératoire . Les 115 patients restants ( 70 % ) ont été r and omisés ; 56 ont eu une cholangiographie alors que 59 n'ont pas eu de cholangiographie peropératoire . La durée de l'hospitalisation postopératoire et le délai entre l'intervention et la reprise de travail étaient similaires dans les deux groupes . La cholangiographie a prolongé l'intervention de 16 ± 1 min ( moyenne ± écart type de la moyenne ) ( p<0.01 ) . Le coût supplémentaire d'une cholangiographie peropératoire a été estimé à environ 700 $ US ( p<0.01 ) . La cholangiographie a pu être effectuée chez 94.6 % des patients , et celle-ci a changé la tactique opératoire chez 4 ( 7.5 % ) patients . Il y a eu un résultat faussement négatif ( 1.9 % ) . La cholangiographie peropératoire n'a pas montré d'anomalie anatomique des voies biliares pouvant les compromettre lors de la dissection . La mortalité a été nulle dans chaque groupe . De même , il n'y a eu aucune morbidité en rapport direct avec la cholangiographie . Dans la période du suivi allant de 2 à 12 mois , il n'y a eu acune lésion biliaire ni de lithiase résiduelle de la voie biliaire cliniquement évidentes . En conclusion , chez un patients ans indication formelle de cholangiographie , la réalisation d'une cholangiographie peropératoire augmente considérablement la durée et le coût de l'intervention . La tactique opératoire a été très peu influencée très peu par les donées de la cholangiographie . La cholécystectomie coelioscopique peut être réalisée sans cholangiographie peropératoire systématique sans augmenter pour autant le risque de lésions des voies biliaires ou de calcul résiduel . ResumenLas opiniones se encuentran divididas respecto a si se debe realizar colangiografía intraoperatoria en forma rutinaria o en forma selectiva en el curso de una colecistectomía laparoscópica . Por ello hemos realizado el primer estudio aleatorizado de colangiografía estática en pacientes que no tenían indicaciones para colangiograma . Se intentó la colecistectomía laparoscópica en 164 pacientes consecutivos ; 49 ( 30 % ) fueron excluidos debido a indicaciones en favor o en contra de colangiografía . Los otros 115 pacientes ( 70 % ) se repartieron al azar 56 a colangiografía y 59 al grupo de no colangiografía . La duración de la hospitalización postoperatoria y del tiempo de retorno a actividad normal fueron idénticos en los dos grupos . Los colangiogramas estáticos añadieron 16 ± 1 min . al procedimiento ( p<0.01 ) y elevaron el costo de la operación en $ 700 ( p<0.01 ) . Los colangiogramas fueron exitosamente realizados en 49.6 % de los pacientes y modificaron el manejo operatorio en 4 ( 7.5 % ) ; hubo un falso positivo ( 1.9 % ) . La colangiografía intraoperatoria no reveló la prescencia de canales biliares aberrantes en riesgo de lesión por la disección opeatoria . No hubo mortalidad o morbilidad relacionada con la colangiografía , y en un seguimiento de 2–12 meses no se registró evidencia clínica de lesión de canales biliares o de cálculos retenidos en el colédoco . En resumen , en pacientes sin indicaciones para colangiografía , la realización de colangiogramas estáticos aumentó notoriamente el tiempo operatorio y el costo de la colecistectomia laparoscópica . Aunque el manejo operatorio de una minoría de pacientes sí fue modificado por la información obtenida , se considera que la colecistectomía laparoscópica puede ser practicada en forma segura en ausencia de colangiogramas con mínimo riesgo de lesión del sistema biliar o de cálculos retenidos A system has been constructed to evaluate the design , implementation , and analysis of  r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials Objective This study evaluated , in a large , heterogeneous population , the outcome of  open cholecystectomy  as it is currently practice d. Summary Background and Data Although cholecystectomy has been the gold st and ard of treatment for cholelithiasis for more than 100 years , it has recently been challenged by the introduction of several new modalities including laparoscopic cholecystectomy . Efforts to define the role of these alternative treatments have been hampered by the lack of contemporary data regarding open cholecystectomy . Methods A population -based study was performed examining all open cholecystectomies performed by surgeons in an eastern and western state during a recent 12-month period . Data compiled consisted of a computerized analysis of Uniformed Billing ( UB-82 ) discharge analysis information from all non-Veterans Administration ( VA ) , acute care hospitals in California ( Office of Statewide Planning and Development [ OSHPD ] ) and in Maryl and ( Health Services Cost Review Commission [ HSCRC ] ) between January 1 , 1989 , and December 31 , 1989 . This data base was supplemented with a 5 % r and om sample of Medicare UB-82 data from patients who were discharged between October 1,1988 , and September 30 , 1989 . Patients undergoing cholecystectomy  were identified based on diagnosis-related groups ( DRG-197 and DRG-198 ) , and then classified by Principal Diagnosis and divided into three clinical ly homogeneous subgroups : acute cholecystitis , chronic cholecystitis , and complicated cholecystitis . Results A total of 42,474 patients were analyzed , which represents approximately 8 % of all patients undergoing cholecystectomy in the United States in any recent 12-month period . The overall mortality rate was 0.17 % and the Incidence rate of bile duct injuries was approximately 0.2 % . The mortality rate was 0.03 % in patients younger than 65 years of age and 0.5 % in those older than 65 years of age . Mortality rate , length of hospital stay , and charges were all significantly correlated ( p < 0.001 ) with age , admission status ( elective , urgent , or emergent ) , and disease status . Conclusions These data indicate that open cholecystectomy currently is a very safe , effective treatment for cholelithiasis and is being performed with near zero mortality . The ultimate role of Since the introduction of laparoscopic cholecystectomy ( LC ) , an increase in accidental  common bile duct ( CBD )  injuries of up to 1.2–1.6 % has been reported . In the present prospect i ve study of 1,710 patients undergoing cholecystectomy ( 1,241 LC procedures and 469 open cholecystectomies [ OC ] ) , we tested the predicative value of routine intraoperative cholangiography ( IOC ) . The IOC was feasible in 92.4 % of the cases in the LC group and in 83 % of cases in the OC group and presented a complete depiction of the extrahepatic bile system in 98.3 % . Anatomic variations of the bile duct system , which influenced the operative management , were found in 13.2 % of cases ( 13.4 % LC versus 12.8 % OC ) . In 2.5 % of the patients , preoperatively undetected CBD stones were also found . Method -specific complications did not occur in any of the patients . Additionally , in a controlled subgroup analysis of 163 patients , we evaluated preoperative intravenous cholangiography ( IVC ) and IOC . Intravenous cholangiography showed only 72.4 % of the operation-relevant anatomic variations ( vs. 100 % by IOC ) ; in 6.1 % of the cases , there were reactions to the dye ( vs. none in IOC ) , and in only 28.6 % of the patients , CBD stones were detected ( vs. 71.4 % IOC ) . There were four bile duct injuries ( 0.29 % ) during LC and two ( 0.4 % ) during OC . All injuries were detected intraoperatively and fixed in the same setting without postoperative complications . In conclusion , we recommend the use of routine IOC during cholecystectomy . By this technique , anatomic variations of the bile duct system will be visualized and therefore accidental injuries will be avoided Background The role of routine intraoperative cholangiography is controversial . The aim of this study was to assess the impact of routine intraoperative cholangiography on the incidence of common bile duct injuries , and to evaluate the operative outcome of laparoscopic cholecystectomy carried out in a major teaching hospital and review the literature . Methods Prospect ively collected data on 3,145 laparoscopic cholecystectomies performed mainly by surgical trainees in the period 1990 to 2002 using routine intraoperative cholangiography with fluoroscopy were review ed . Results The mean age of the study sample ( 65.6 % male , 34.4 % female ) was 54 years , and 16.9 % of the patients had clinical acute cholecystitis . The conversion rate to open cholecystectomy was 4.3 % . Intraoperative cholangiography was attempted for 90.7 % of the patients with a 95.9 % success rate . Five patients ( 0.16 % ) had common bile duct injuries . Four injuries had occurred in the first 5 years . One injury ( 0.06 % ) had occurred after 1995 . This injury was identified intraoperatively and repaired laparoscopically . Routine intraoperative cholangiography prevented one definite common bile duct transection . Conclusions In this series using routine intraoperative cholangiography , there was a low rate and severity of common bile duct injuries , with a high intraoperative recognition rate . There was no bile duct transection or major injury requiring common bile duct reconstruction . Although intraoperative cholangiography helped in the immediate identification of injuries and the institution of appropriate therapy , injury was not completely prevented INTRODUCTION Common bile duct ( CBD ) stones can cause serious morbidity or mortality , and evidence for them should be sought in all patients with symptomatic gallstones undergoing cholecystectomy .  Routine intra-operative cholangiography ( IOC ) involves a large commitment of time and re sources , so a policy of selective cholangiography was adopted . This study prospect ively evaluated the policy of selective cholangiography for patients suspected of having choledocholithiasis , and aim ed to identify the factors most likely to predict the presence of CBD stones positively . PATIENTS AND METHODS Data from 501 consecutive patients undergoing laparoscopic cholecystectomy ( LC ) for symptomatic gallstones , of whom 166 underwent IOC for suspected CBD stones , were prospect ively collected . Suspicion of choledocholithiasis was based upon : ( i ) deranged liver function tests ( past or present ) ; ( ii ) history of jaundice ( past or present ) or acute pancreatitis ; ( iii ) a dilated CBD or demonstration of CBD stones on imaging ; or ( iv ) a combination of these factors . Patient demographics , intra-operative findings , complications and clinical outcomes were recorded . RESULTS Sixty-four cholangiograms were positive ( 39 % ) . All indications for cholangiogram yielded positive results . Current jaundice yielded the highest positive predictive value ( PPV ; 86 % ) . A dilated CBD on pre-operative imaging gave a PPV of 45 % for CBD calculi ; a history of pancreatitis produced a 26 % PPV for CBD calculi . Patients with the presence of several factors suggestive of CBD stones yielded higher numbers of positive cholangiograms . Of the 64 patients having a laparoscopic common bile duct exploration ( LCBDE ) , four ( 6 % ) required endoscopic retro grade cholangiopancreatography ( ERCP ) for retained stones ( 94 % successful surgical clearance of the common bile duct ) and one ( 2 % ) for a bile leak . Of the 335 patients undergoing LC alone , three ( 0.9 % ) re-presented with a retained stone , requiring intervention . There were 12 ( 7 % ) requiring conversion to open operation . CONCLUSIONS A selective policy for intra-operative cholangiography yields acceptably high positive results . Pre-operatively , asymptomatic bile duct stones rarely present following LC ; thus , routine imaging of the biliary tree for occult calculi can safely be avoided . Therefore , a rationing approach to the use of intra-operative imaging based on the pre-operative indicators presented in this paper , successfully identifies those patients with bile duct stones requiring exploration . Laparoscopic bile duct exploration , performed by an experienced laparoscopic surgeon , is a safe and effective method of clearing the bile duct of calculi  , with minimal complications , avoiding the necessity for an additional intervention and prolonged hospital stay Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . A prospect i ve r and omized trial was undertaken to determine if selective peroperative cholangiography result ed in greater morbidity and mortality from missed common bile duct ( CBD ) stones . Five hundred and thirty-nine consecutive cholecystectomies were performed over a 3-year period . Two hundred and fifty-four had indications for m and atory peroperative cholangiography and were excluded from the trial . The remaining 285 patients , without a history of jaundice , pancreatitis or abnormal liver function tests , were r and omized blindly into two groups . Group 1 underwent peroperative cholangiography ( PC ) and group 2 did not . If the surgeon found a dilated CBD at surgery then these patients were also excluded from the trial . Selective peroperative cholangiography revealed an unsuspected CBD calculus in 16 of the 132 patients ( 12 % ) . Up to the time of review no patient from group 2 presented with symptoms or complications from retained CBD stones . One patient in group 1 had endoscopic removal of a retained CBD calculus 16 months after cholecystectomy . All patients were sent a question naire at least three years after surgery and 210 responded ( 74 % ) . One hundred and thirty ( 62 % ) of the respondents had  peroperative cholangiography .  There were 11 deaths from unrelated causes . No difference between the two groups was found for postoperative dietary habit , dyspepsia , pain , flatulence , diarrhoea or signs of biliary obstruction . It seems from these results that a policy of selective cholangiography in our h and s may miss a 12 % incidence of unsuspected stones but , importantly , this does not appear to influence postoperative morbidity or mortality . ( ABSTRACT TRUNCATED AT 250 WORDS Abstract . Bile duct injury ( BDI ) during  laparoscopic cholecystectomy ( LC )  which may result in patient disability or death are reported to occur more frequently when compared to open surgery . The aim of this nationwide prospect i ve study beyond the laparoscopic learning curve was to analyze the incidence , risk factors , and management of major BDI . During a 3-year period ( 1995–1997 ) 130 items of all LC data were collected on a central computer system from 84 surgical institutions in Switzerl and by the Swiss Association of Laparoscopic and Thoracoscopic Surgery and evaluated for major BDIs . Simple biliary leakage was excluded from analysis . There were 12,111 patients with a mean age of 55 years ( 3–98 years ) enrolled in the study .  The overall BDI incidence was 0.3 % , 0.18 % for symptomatic gallstones , and 0.36 % for acute cholecystitis . In cases of severe chronic cholecystitis with shrunken gallbladder , the incidence was as high as 3 % . Morbidity and mortality rates were significantly increased in BDIs . BDI was recognized intraoperatively in 80.6 % , in 64 % of cases by help of intraoperative cholangiography . Immediate surgical repair was performed laparoscopically ( suture or T-drainage ) in 21 % ; in 79 % , open repair ( 34 % simple suture , 66 % Roux-en-Y reconstruction ) was needed . The BDI incidence did not decrease during the last 7 years . In 47 % , BDIs were caused by experienced laparoscopic surgeons , perhaps because they tend to operate on more difficult patients . In conclusion , the incidence of major BDIs remains constant in Switzerl and at a level of 0.3 % , which is still higher when compared to open surgery . However , most cases are now detected intraoperatively and immediately repaired which ensures a good long-term outcome . For preventing such injuries , exact anatomical knowledge with its variants and a meticulous surgical dissecting technique especially in case of acute inflammation or shrunken gallbladder are m and atory A prospect i ve , controlled , r and omized trial was conducted in 275 patients with symptomatic gall stone disease , whose history , laboratory data or sonographical findings did not suggest common bile duct stones . Of these patients , 137 did not undergo intraoperative fluoroscopic cholangiography ( IOC ) , but in the remaining 138 patients IOC was attempted . In 111 cases ( 80.4 % ) the biliary system was sufficiently visualized . In 3 patients ( 2.7 % ) calculi in the cystic or common bile duct were diagnosed , which would have been overlooked without IOC . IOC was false-positive in one case . One year after the operation the patients were asked to return for a follow-up examination . Three patients in the group without IOC had had symptomatic passage of a stone , and one had a common bile duct stone removed by endoscopic papillotomy . A retained stone was discussed as etiology for a pancreatitis in a fifth patient in this group . No patient sustained long-term sequelae from the retained common bile duct stones . None of the patients in the IOC group had evidence of cholangiolithiasis at follow-up . There was no difference between the study groups concerning the incidence of post-operative complications . The operations with IOC  lasted significantly longer ( 92 + /- 31 min vs 77 + /- 28 min ) . According to our data and those published earlier , the additional financial and logistic expenditure associated with routine IOC is not justified . Patients with the preoperative suspicion of a common bile duct stone should have endoscopic bile duct clearance ( ERCP and EPT ) prior to cholecystectomy The role of intraoperative cholangiography during laparoscopic cholecystectomy was prospect ively evaluated in 514 patients undergoing laparoscopic cholecystectomy .  Before surgery , all patients were assigned to one of three groups depending on the likelihood of their having common bile duct stones . Stratification was based on objective historical , laboratory , or radiologic criteria . In 453 patients deemed unlikely to have stones , laparoscopic cholecystectomy was performed without cholangiography . Of these patients , four had retained stones ( 0.9 % ) . In 25 patients likely to have stones , preoperative endoscopic retro grade cholangiopancreatography identified stones in six patients ( 24 % ) . In 36 patients whose likelihood of having stones was deemed indeterminate , intraoperative cholangiography was performed at laparoscopic cholecystectomy . A common bile duct stone was identified in one patient ( 2.8 % ) . One common bile duct injury occurred in the group deemed unlikely to have stones , and this injury would not have been prevented by intraoperative cholangiography . We conclude that preoperative assessment will identify common bile duct stones and that routine cholangiography is not warranted . Meticulous dissection of the cystic duct at its origin at the infundibulum will prevent common bile duct injury To assess the value of routine peroperative cholangiography ( PC ) , 457 patients undergoing cholecystectomy for gallstone disease were prospect ively screened for the presence of 11 predefined criteria indicating possible choledocholithiasis . Two hundred and eighty patients who had no positive criteria and in whom preoperative endoscopic retro grade cholangiography ( ERC ) had not been performed were r and omized to PC or no PC .  The patients were followed up 12 months postoperatively , and those who had signs or symptoms of possible retained common bile duct calculi were referred to ERC . The difference in mean operative time between the 2 treatment groups was 23.3 minutes . Four patients ( 2.8 % ) in the PC group had unsuspected common bile duct calculi , and in 3 patients ( 2.1 % ) , the PC was false-positive . On follow-up , no case of retained common bile duct calculi was found in either group . The rate of postoperative complications was significantly higher in the PC group than in the non-PC group . It is concluded that PC should be performed only in patients with indications of common bile duct disease or in whom clarification of the anatomy is necessary . RésuméPour apprécier la valeur de la cholangiographie opératoire de routine , 457 sujets subissant une cholécystectomie pour lithiase vésiculaire ont été étudiés prospect ivement en fonction de 11 critères de présomption de lithiase cholédocienne . Deux cent quatre-vingts d'entre eux qui ne présentaient pas un critère de présomption et chez qui n'avait pas été pratiquée une cholangiographie rétro grade endoscopique ont été soumis à une cholangiographie opératoire à la suite d'un choix par tirage au sort . Ils furent ensuite suivis pendant une période de 12 mois au décours de l'intervention de manière que ceux qui présentaient des symptômes et des signes en faveur de la présence de calculs oubliés dans le cholédoque fussent soumis à une cholangiographie rétro grade endoscopique . Premier élément , la durée de l'intervention fut augmentée en moyenne de 23.3 minutes lorsque fut pratiquée la cholangiographie opératoire . Quatre malades ( 2.8 % ) ainsi explorés présentaient des calculs cholédociens . Trois cas de faux positifs ( 2.1 % ) furent enregistrés . Aucun cas de lithiase résiduelle n'a été découvert dans les 2 groupes . Le taux des complications postopératoires fut plus élevée lorsque la cholangiographie opératoire fut pratiquée . On peut conclure de ces faits , que cette exploration doit Être proposée seulement lorsque la présence de calculs dans la voie biliare principale est à envisager ou qu and il est nécessaire de préciser l'anastomie des voies biliares . ResumenCon el objeto de determinar el valor de la colangiografía peroperatoria ( CP ) , 457 pacientes programados para colecistectomía por enfermedad litiásica biliar fueron preoperatoriamente tamizados para establecer la presencia de 11 criterios predefinidos indic and o posible coledocolitiasis . Doscientos ochenta pacientes que no presentaban criterios positivos y en quienes la colangiografía retrógrada endoscópica ( CRE ) no había sido practicada fueron asignados al azar a CP o a no CP . Los pacientes fueron seguidos por 12 meses después de la operación , y aquellos con signos o síntomas de posibles cálculos retenidos en el colédoco fueron referidos para CRE . La diferencia en el tiempo operatorio promedio entre los 2 grupos fue de 23.3 minutos . Cuatro pacientes ( 2.8 % ) en el grupo con CP presentaron cálculos inesperados en el colédoco , y en 3 casos ( 2.1 % ) , la CP result ó falsapositiva . En el curso del seguimiento , ningÚn caso de cálculos retenidos en el colédoco fue hallado en uno u otro grupo . La tasa de complicaciones postoperatorias fue significativamente mayor en el grupo con CP que en el grupo sin CP . Se concluye que la CP debe ser practicada sólo en pacientes con criterios de patología coledociana o en quienes sea necesario clarificar la anatomía
target: N-OTC is associated with shorter operative time and fewer peri-operative complications , and it is comparable to R-OTC in terms of CBD injury risk during cholecystectomy .
  R-OTC is helpful for peri-operative CBD stone detection and there is therefore reduced readmission for retained CBD stones .
  The N-OTC approach may be adopted routinely for patients undergoing laparoscopic cholecystectomy providing there are no clinical , biochemical or radiological features suggestive of CBD stones .
background: INTRODUCTION The aim of this review was to systemically analyse trials evaluating the efficacy of routine on-table cholangiography ( R-OTC ) versus no on-table cholangiography ( N-OTC ) in patients undergoing cholecystectomy .