World J. Surg. 10, 996-1002, 1986
rldJ mal of S ir ry 9 1986by the Soci6t6 Internationalede Chirurgie
Consequences of Routine Peroperative Cholangiography During Cholecystectomy for Gallstone Disease: A Prospective, Randomized Study Martin Hauer-Jensen, M.D., Rolf K~tresen, M.D., Knut Nygaard, M.D., Kaare Solheim, M.D., Einar Amlie, M.D., 0yvind Havig, M.D., and Karl O. Viddal, M.D. Departments of Surgery, Ullevaal Hospital, Central Hospital of Akershus, Lovisenberg Hospital, and Diakonhjemmet Hospital, Oslo and Nordbyhagen, Norway To assess the value of routine peroperative cholangiography (PC), 457 patients undergoing cholecystectomy for gallstone disease were prospectively 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 retrograde cholangiography (ERC) had not been performed were randomized 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.
The routine use of peroperative cholangiography (PC) during cholecystectomy for gallstone disease is a controversial issue. Many authors advocate routine PC in all patients, the main argument being that asymptomatic common bile duct (CBD) calculi may be detected [1-9]. Others maintain that the benefits of detecting the relatively few cases of unsuspected CBD stones are outweighed by an
Reprint requests: M. Hauer-Jensen, M.D., Radiation Research Laboratory, 14 Medical Laboratories, University of Iowa, Iowa City, Iowa 52242, U.S.A.
increased postoperative morbidity as a result of unnecessary choledochotomies in cases of falsepositive cholangiograms [10-15]. Despite the abundance of articles in which various aspects of routine PC have been discussed, relatively few prospective investigations have been performed and, to our knowledge, no randomized trial evaluating the consequences of performing PC in patients without indications of CBD disease has been previously published. Material and M e t h o d s
From July, 1982, through January, 1984, a total of 457 patients undergoing cholecystectomy for gallstone disease were prospectively screened for the presence of 11 predefined criteria indicating possible choledocholithiasis (Table 1). Two hundred and eighty patients who had no positive criteria and had not been subjected to preoperative endoscopic retrograde cholangiography (ERC) were randomized to PC or no PC. These patients constitute the material of the present study. Twenty additional patients also fulfilling the conditions for randomization were not included in the study; 5 were high-risk operative patients in whom the surgeon did not want to prolong the operation by performing PC, 9 patients had acute cholecystitis and marked inflammatory changes and the surgeon regarded PC as hazardous, and 6 patients were inadvertently not randomized. Three patients were erroneously randomized by the surgeon despite the presence of positive criteria of possible choledocholithiasis and were withdrawn from the study. Of the 280 patients who were correctly screened and entered in the trial, 142 were randomized to PC
M. Hauer-Jensen et al.:
CholangiographyDuring Cholecystectomy
Table 1. Criteria of possible choledocholithiasis.
Clinical presentation Jaundice (present, recent, or recurrent) Light colored feces/dark urine Pancreatitis (present or recent) Septic fever (present or recent) Preoperative investigations Common bile duct diameter > 10 mm Common bile duct calculi Serum alkaline phosphatases >250 units/1 Serum bilirubin >25/xmol/1 Intraoperative findings Common bile duct diameter > 10--12 mm Cystic duct diameter >4-5 mm Palpable common bile duct calculi
and 138 to no PC. The series included 211 women aged 20-89 years (mean 53.4) and 69 men aged 24-86 years (mean 54.0). In patients randomized to PC, manual contrast injection without fluoroscopy was performed through a catheter inserted into the cystic duct and a minimum of 2 films were obtained and interpreted by the surgeon. F o r all patients, the duration of the operation, the results of PC when performed, postoperative complications, and the duration of postoperative hospitalization were recorded. Twelve months after the operation, a questionnaire was sent to each patient asking about episodes of abdominal pain, jaundice, subsequent hospitalization, and other manifestations of illness. Patients who did not return the questionnaire were contacted by telephone. All patients who complained of upper right abdominal pain episodes or who were otherwise suspected of having biliary tract disease were summoned to the outpatient department at the hospital in which they had undergone surgery and seen by one of the authors. Patients in whom there was no clinical suspicion of biliary tract disease following examination, who had normal values of serum bilirubin and alkaline phosphatases, and in whom a plausible explanation for their complaints was found were not subjected to further examination. The remaining patients were referred to ERC in order to rule out biliary disease. Statistical calculations were performed with the Fisher-Irwin test, the 2-sample median test, and the Student's t-test where appropriate [16]. All tests were 2-sided and a level of significance of 0.05 was used.
Results
There was no significant difference between the 2 treatment groups with regard to mean age, sex distribution, and number of preoperative imaging
997
Table 2. Treatment groups.
No. of patients Mean age (yr) Female/male ratio Intravenous cholangiography (%) Peroral cholecystography (%) Ultrasonography (%) Cholescintigraphy (%)
Non-PC
PC
138 54.3 3.2 30.4 51.4 56.5 2.9
142 52.8 3.0 27.5 44.4 62.0 4.9
PC = Peroperative cholangiography. Table 3. Results of peroperative cholangiography.
Asymptomatic common bile duct calculi (%) Common bile duct explorations (%) False-positive PC (%) False-negative PC (%) Unsuccessful PC (%)
Non-PC
PC
0 0
2.8 4.2 2.1 0 10.6
PC = Peroperative cholangiography.
investigations performed (Table 2). The results of PC and the percentage o f patients having CBD explorations are shown in Table 3. In the group randomized to PC, CBD calculi were detected and r e m o v e d in 4 patients (2.8%). One of these patients had to undergo an endoscopic sphincterotomy because of a retained calculus found on postoperative T-tube cholangiography. In 3 patients (2.1%), 2 of whom were subjected to c o m m o n bile duct exploration, the cholangiograms were falsepositive. No case of a false-negative PC was detected. Due to technical or other difficulties, the PC was considered unsuccessful or nondiagnostic in 15 patients (10.6%). in the group of patients in which PC was not performed, no case of choledocholithiasis was observed in the postoperative period. Of the 3 patients erroneously randomized despite positive criteria of possible choledocholithiasis and withdrawn from the trial, 1 proved to have a CBD stone which was r e m o v e d by endoscopic sphincterotomy. There was no case of operative bile duct injury among the 280 patients in the study; however, 1 of the 9 patients with acute cholecystitis who were excluded because PC was regarded as hazardous suffered an accidental transection of the CBD, which was not detected peroperatively. The operative time, duration of postoperative hospitalization, and complication rate are shown in Table 4. The mean duration of operation in the group having c h o l e c y s t e c t o m y alone was 58.1 minutes (95% confidence interval, 53.7-62.5 minutes),
World J. Surg. Vol. 10, No. 6, December 1986
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Table 4. Operative time, duration of postoperative hospi-
talization, and complication rate.
Mean operative time (min) Postoperative hospitalization (days) mean/median/mode Complication rate (%) Mortality (%)
Table 5. Postoperative complications. Number of patients
Non-PC
PC
58.1
81.4
6.2/5/4 5.8 0
6.3/5/4 14.8 0
PC = Peroperative cholangiography.
as compared to 81.4 minutes (95% confidence interval, 75.%86.9 minutes) in the group in which PC was performed. There was a significantly higher rate of postoperative complications in the group of patients in which PC was performed, as compared to the group that underwent cholecystectomy alone (14.8% versus 5.8%). This difference also remained significant when the 6 patients in whom CBD exploration was performed were disregarded. Table 5 shows the number of patients having postoperative complications, their mean age, and mean operative time. For each patient only the most serious complication is listed. In the PC group, there was no significant difference in mean age or in operative time between patients who had complications and those who did not. Patients in the non-PC group who had postoperative complications had a significantly higher mean age than patients in whom the postoperative course was uneventful. The difference in mean operative time between these 2 groups (15.3 minutes) was not statistically significant. There was no significant difference in the length of hospital stay between the 2 treatment groups nor was there perioperative mortality in either group. Of the 280 patients included in the trial, 275 (98.2%) were located 1 year postoperatively. Two patients had died from unrelated causes during this period. One hundred and seventy-eight patients (65%) had no complaints, 25 patients (9%) had experienced transient discomfort during the period immediately following the operation, and 33 patients (12%) had various symptoms of nonbiliary origin. Thirty-nine patients (14%) were referred to examination by 1 of the authors because of symptoms of possible biliary etiology. Seven patients were referred to ERC, but none was found to have retained biliary calculi.
Discussion
Evidence from numerous articles and several monographs [1, 17, 18] suggests that PC is superior to other imaging modalities in the diagnosis of CBD
Non-PC Wound infection 3 Subhepatic accumulation 2 Wound dehiscence 0 Retained common bile duct calculi 0 Pneumonia I Thromboembolism 1 Pyelonephritis 0 Cardiac arrest 1 Total 8 Mean age (yr) 65.5 Mean operative time (min) 72.5
PC 4 7 1 1 5 1 2 0 21 55.9 81.9
PC = Peroperative cholangiography.
calculi, with the possible exception of peroperative ultrasonography [19] and ERC [20, 21]. Most authors also agree that the diagnostic accuracy of PC surpasses that of the traditional clinical criteria of choledocholithiasis [3, 4, 22]. Early articles following the introduction of PC focused mainly on the reduced incidence of negative choledochotomies in patients with traditional criteria for CBD exploration; however, in recent years the main issue of debate has been whether PC should be performed in all cases of cholecystectomy or only in patients in whom CBD disease is suspected. In studies published to date on this subject, PC has either been performed in nearly all patients [3, 5, 10, 15, 22-26] or only in patients selected by various criteria [8, 12-14, 27]. The fact that such investigations do not include comparable treatment groups renders their interpretation with regard to advantages or disadvantages of routine PC difficult; therefore, a trial in which the patients are randomized to either PC or no PC, as in the present study, is necessary. The predictive ability of the various criteria used to select patients for randomization in the present study has been discussed elsewhere [28]. The main argument in favor of always performing PC during cholecystectomy is the detection of asymptomatic choledocholithiasis. Depending on the technique of PC and on the indicators of CBD calculi used, unsuspected stones have been found in up to 7% of the patients [29], although most authors report considerably lower figures [3, 12, 14, 22]. The clinical significance of such calculi is debated, however, since a large proportion probably pass spontaneously [12, 15]. Since CBD exploration significantly increases the risk of postoperative complications and mortality [28, 30-32], the detection of asymptomatic CBD calculi which would otherwise pass spontaneously may unnecessarily increase postoperative morbidity. In the present investiga-
M. Hauer-Jensen et al.: Cholangiography During Cholecystectomy
tion, 2.8% of the patients in the PC group had CBD calculi, whereas no case of choledocholithiasis was found in the non-PC group either at operation or at follow-up. This is in accordance with the theory that most calculi that are small enough to pass through a normally calibrated cystic duct will also be able to pass the papilla of Vater provided no obstruction is present [33]; however, since the period of follow-up in the present series is only 1 year, the possibility of asymptomatic retained CBD calculi cannot be excluded with absolute certainty. Because of the low morbidity and mortality and the high success rate, endoscopic papillotomy has become the treatment of choice in many cases of choledocholithiasis [34-38]. Consequently, retained CBD stones often have less serious implications than previously since the majority may be removed without reoperation. In addition to choledochotomies in patients with asymptomatic CBD calculi, some of which are possibly unnecessary, routine PC also leads to a certain number of CBD explorations in cases of false-positive cholangiograms. The frequency of false-positive PC reported in the literature varies from 0.4% [1] to 6.5% [24] and, to a considerable degree, depends on technique and equipment. The accuracy of PC may be increased by the use of optimal x-ray equipment, preferably with fluoroscopy and serial film facilities [1], controlled contrast flow and injection pressure [39], and other technical refinements for use in special cases [40-46]. Such improvements may also significantly reduce the proportion of false-negative cholangiograms reported in up to 2.1% [14], and may reduce the number of nondiagnostic investigations. Interpretation of the cholangiograms in cooperation with a radiologist seems to increase the diagnostic accuracy [24, 25, 29]. Several authors emphasize the value of routine PC in detecting bile duct anomalies thereby reducing the risk of iatrogenic injuries, of which a great proportion occur during seemingly uncomplicated cholecystectomies [47, 48]. The incidence of bile duct injuries during cholecystectomy is reportedly about ! in 400 operations [49]. Due to the lack of randomized studies, it is uncertain to what extent such lesions may be prevented by performing PC. In a recent review by White and Hart [50], the number of bile duct injuries caused by overmanipulation during attempts to carry out PC doubled the number of injuries due to mistakes in dissection. In our study, there were no bile duct injuries among the 280 randomized patients; however, 1 patient who was excluded from the trial because of inflammatory changes suffered a transection of the CBD which was not detected at the primary operation. This might possibly have been avoided if PC had
999
been performed. Another patient, erroneously included in the study and randomized to the non-PC group despite an elevated serum alkaline phosphatase level, had a retained CBD calculus that had to be removed postoperatively by endoscopic sphincterotomy. A policy of performing PC routinely in all cases of cholecystectomy probably minimizes the risk of erroneous omissions in patients with indicators of CBD disease or in whom clarification of the anatomy is necessary. The prolongation of operative time due to PC reported in the literature varies between 5 and 35 minutes [1, 51]. In the present study, the difference in mean operative time between the 2 treatment groups was 23.3 minutes. Improvements in Operating room routines, technique, and equipment may reduce considerably the time needed to perform PC. Very few studies have reported an increased postoperative morbidity due to PC [27]. Allergic reactions to the contrast medium are extremely rare since the absorption is usually negligible [52]. The investigation seems to be contraindicated only in patients with infected bile, in whom PC without manometric control may increase the incidence of bacteremia [53]. Many authors maintain that there are no complications associated with PC [6, 7, 29, 54]; however, this assumption is based on results from studies that do not include comparable treatment groups. In the present investigation there was a significantly increased rate of postoperative complications in the PC group. The difference persisted when patients subjected to CBD exploration were disregarded. Patients in the non-PC group who had complications had a significantly higher mean age than the rest of the group, whereas this was not the case for the PC group. Since there is a positive correlation between age and the risk of postoperative complications following cholecystectomy [30, 32], these findings also indicate that PC might increase postoperative morbidity. Whether this is due to the prolonged operative time or directly associated with the procedure remains to be elucidated.
Conclusion
There were no cases of retained CBD calculi or bile duct injuries in the non-PC group and there were significantly fewer postoperative complications in this group than in the PC group. The present investigation, therefore, did not seem to suggest any disadvantage from omitting PC in patients without indications of CBD disease. Our results strongly support a policy of performing PC only in selected patients; however, in order to avoid erroneous
1000
omissions, the importance of screening with regard to indicators of possible choledocholithiasis and the identification of patients in whom radiographic visualization of the bile ducts is necessary to clarify the anatomy must be emphasized.
R~sum~
Pour appr6cier la valeur de la cholangiographie op6ratoire de routine, 457 sujets subissant une chol6cystectomie pour lithiase v6siculaire ont 6t6 6tudi6s prospectivement en fonction de 11 crit~res de pr6somption de lithiase chol6docienne. Deux cent quatre-vingts d'entre eux qui ne pr6sentaient pas un crit~re de pr6somption et chez qui n'avait pas 6t6 pratiqu6e une cholangiographie r6trograde endoscopique ont 6t6 soumis ~ une cholangiographie op6ratoire A la suite d'un choix par tirage au sort. Ils furent ensuite suivis pendant une p6riode de 12 mois au d6cours de l'intervention de mani~re que ceux qui pr6sentaient des sympt6mes et des signes en faveur de la pr6sence de calculs oubli6s darts le chol6doque fussent soumis A une cholangiographie r6trograde endoscopique. Premier 616ment, la dur6e de l'intervention fut augment6e en moyenne de 23.3 minutes lorsque fut pratiqu6e la cholangiographie op6ratoire. Quatre malades (2.8%) ainsi explor6s pr6sentaient des calculs chol6dociens. Trois cas de faux positifs (2.1%) furent enregistr6s. Aucun cas de lithiase r6siduelle n'a 6t6 d6couvert darts les 2 groupes. Le taux des complications postop6ratoires fur plus 61ev6e lorsque la cholangiographie op6ratoire fut pratiqu6e. On peut conclure de ces faits, que cette exploration doit 6tre propos6e seulement lorsque la pr6sence de calculs dans la voie biliare principale est ~t envisager ou quand il est n6cessaire de pr6ciser l'anastomie des voies biliares.
Resumen
Con el objeto de determinar el valor de la colangiograffa peroperatoria (CP), 457 pacientes programados para colecistectomia por enfermedad liti~tsica biliar fueron preoperatoriamente tamizados para establecer la presencia de 11 criterios predefinidos indicando posible coledocolitiasis. Doscientos ochenta pacientes que no presentaban criterios positivos y en quienes la colangiografia retr6grada endosc6pica (CRE) no habfa sido practicada fueron asignados al azar a CP o a no CP. Los pacientes fueron seguidos pot 12 meses despu6s de la operaci6n, y aquellos con signos o s~ntomas de posibles cfilculos retenidos en el col6doco fueron referidos para CRE. La diferencia en el tiempo
World J. Surg. Vol. 10, No. 6, December 1986
operatorio promedio entre los 2 grupos fue de 23.3 minutos. Cuatro pacientes (2.8%) en el grupo con CP presentaron cfilculos inesperados en el col6doco, y en 3 casos (2.1%), la CP result6 falsapositiva. En el curso del seguimiento, ningt~n caso de cfilculos retenidos en el col6doco rue hallado en uno u otro grupo. La tasa de complicaciones postoperatorias fue significativamente mayor en el grupo con CP q u e e n el grupo sin CP. Se concluye que la CP debe ser practicada s61o en pacientes con criterios de patologfa coledociana o en quienes sea necesario clarificar la anatomfa. References
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