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Precholecystectomy endoscopic cholangiography and stone removal is not superior to cholecystectomy, cholangiography, and common duct exploration
Precholecystectomy Endoscopic Cholangiography and Stone Removal Is Not Superior to Cholecystectomy, Cholangiography, and Common Duct Exploration Greg V. Stiegmann, MD, John S. Goff, MD, Ashraf Mansour, MD, Nathan Pearlman, Robert M. Reveille, MD, Lawrence Norton, MD, DUW, c&ado
Thirty-four patients with suspected common bile duct stones were randomized to undergo endoscopic cholangiography and stone removal prior to open cholecystectomy or to have open cholecystectomy, operative cholangiography, and common bile duct exploration. Sixteen underwent the first protocol, and 18 the second. Analysis of the ability to clear stones from the common bile duct, morbidity, mortality, hospital stay, length of operation, and hospital cost showed no difference in outcome between patients treated by either method. These data suggest there is neither an advantage nor a disadvantage to treating patients with suspected duct stones by precholecystectomy endoscopic cholangiography and stone removal.
MD,
0 surgical treatment scopic cholangiography,
perative common bile duct exploration is standard for choledocholithiasis. Endosphincterotomy, and stone removal is also effective for the removal of common bile duct stones but, in North America, has been employed primarily in patients with retained or recurrent duct stones following cholecystectomy or in those not considered lit for laparotomy. The purpose of this study was to compare operative common duct exploration with preoperative endoscopic treatment of common duct stones in patients who required elective cholecystectomy and had laboratory and/or ultrasound abnormalities suggesting the presence of common duct stones. PATIENTS AND METHODS
From June 1986 to March of 1990, 34 patients who required elective cholecystectomy and were suspected of harboring common duct stones were randomized to undergo either operative or combined endoscopic and operative treatment. Patients with ascending cholangitis and those who underwent operation for acute cholecystitis were excluded as were those with underlying liver disease, bleeding disorders, previous gastric surgery precluding endoscopic examination of the bile duct, and those who had prior biliary tract operations. Risk factors for the suspicion of choledocholithiasis preoperatively included any one or more of the following criteria: serum bilirubin (total) greater than 2 mg/dL (two times normal), serum alkaline phosphatase greater than 235 IU/L (two times normal), serum amylase greater than 240 U/L (two times normal), ultrasound bile duct greater than 8 mm diameter, and ultrasound bile duct showing stone in duct. Serum amylase was employed as a criterion only in patients in whom elevation persisted to within 24 hours of operation or endoscopy. Randomization was done by drawing sealed envelopes that contained computer-generated random assignments. The operation-only cohort had conventional open cholecystectomy with intraoperative cholangiography (two views) and common duct exploration if the cholangiogram confirmed the presence of duct stones. Duct exploFromthe Dcnartments of SurgervKWS.AM.NP. LN1andMedicine ration was performed in conventional fashion, and chole(JSG,RMR’),Universityof r?o&do and Dekver’VeteransAdminisdochoscopy was employed at the discretion of the trationHospitals,Denver,Colorado. Requestsfor reprints should be addressed to Greg V. Stiegmann, operating surgeon. Operation was accomplished as soon MD,UCHSC,BoxC-313,4200East9th Avenue,Denver,Colorado after randomization as the elective operating schedule 80262. tinted as a posterpaperat the 32ndAnnualMeetingof the allowed. Patients in the endoscopicloperative group had societyfor Surgery of the Alimentary Tract, New Orleans, Louisiana, endoscopic cholangiography followed by sphincterotomy May 20-22, 1991. and stone removal if stones were seen on the endoscopic THE AMERICAN JOURNAL OF SURGERY
VOLUME 163 FEBRUARY 1992
227
STIEGMANN ET AL
TABLE
I
Preoperatlve Variables in Endoscopic/Operative and Operative Only Patlents Variable
Endo/Op
(n = 16)
Op Only (n = 18)
Age (years)
46.3 + 21.7
38.1 f 14.8
Weight (kg)
72 + 20.4
74.7 2 23.2
4.36 2 2.62
3.18 * 3.00
Bilirubin (mg/dL) Alkaline Phosphate (lull)
469 + 250
506 2 350
Amylase (U/L)
178 f 243
375 + 668
Dilated duct (US)
6116
6118
Stone in duct (US)
l/16
3118
All values are mean values f standard deviation of the mean. EndolOp = endoswpic cholangiography and stone removal prior to operative open cholacystectomy; Op = operation only; (US) = as determined by preoperative uRrasound. No differences were statistically significant.
cholangiogram. Endoscopic procedures were scheduled when possible to allow performance of cholecystectomy the following day. The operation-only cohort was assessed for the ability of the surgeon to clear the common duct of stones as judged by postoperative t-tube cholangiography performed 10 or more days following operation. The endostopic/operative group was assessed for the ability of the endoscopist to clear the common duct of stones as determined by retrograde cholangiography at the time of endoscopy and at operative cholangiography thereafter if the operating surgeon or endoscopist felt an additional cholangiogram was indicated. Morbidity was defined as any untoward event that required active treatment or prolonged hospitalization. Hospital charges were ob tained directly from the hospital finance office and reflected the total hospital (nonprofessional) bill the patient received for the admission. This study was approved by the investigational review board of our hospitals, and all patients gave informed consent. Statistical analysis was by chi square and Student’s ttest with significance defined at p <0.05.
operative exploration and only achieved duct clearance with radiologically guided stone extraction via the t-tube tract. An additional patient who had successful endoscopic duct clearance was observed during manipulation of the gallbladder at operation to pass a stone from the cystic duct into the common duct. Duct exploration was required to clear the common duct. All other patients with the exception of the one with cholangiocarcinoma diagnosed at endoscopic cholangiography and an additional patient found to have advanced cirrhosis at laparotomy had uneventful open cholecystectomy. Both of the latter patients were excluded from further analysis. The mean interval between endoscopy and cholecystectomy was 1.6 (0 to 5) days. Seven of the 18 patients treated by operation only were found to have common duct stones and had operative common duct exploration in addition to cholecystectomy. Four of these required transduodenal sphincteroplasty for removal of stones impacted in the ampulla. One of the seven had a retained stone that was removed radiologically via the t-tube tract. Complications in both cohorts only occurred after operation and included minor wound infections, ileus, bile fistula, and postoperative fevers. None of the complications were directly attributable to the endoscopic procedure, and all resolved without operative intervention. Results with regard to morbidity, overall hospital stay, and costs are summarized in Table II.
Independent analysis of the patients in both cohorts who had common duct stones showed no statistically significant differences in mean hospital stay, morbidity, or cost between these two subgroups. No correlation with age and the presence or absence of choledocholithiasis was present in these patients. COMMENTS
Sixteen patients were randomized to endoscopy followed by operation and 18 to operation alone. Characteristics of the two cohorts are presented in Table I. All patients in the endoscopic/operation arm had successful endoscopic cholangiography. Eight (50%) had positive findings including stones (7) and cholangiocarcinoma (1). The remaining eight had normal endoscopic cholangiograms. Stones were successfully removed endoscopitally in five of the seven patients (71%). One of the five required two endoscopic procedures. Two additional patients failed to achieve duct clearance with the endoscopic technique because of the large size of common duct stones. Both had operative duct exploration at the time of cholecystectomy. One patient had retained stones after
This study indicates that performance of endoscopic retrograde cholangiography and stone removal prior to open cholecystectomy in patients suspected of harboring common duct stones is not superior to conventional open cholecystectomy, operative cholangiography, and common bile duct exploration. Endoscopic cholangiography and removal of duct stones prior to cholecystectomy resulted in an overall increase in hospitalization (mean: 2.2 days) when compared with operation alone. This increase appeared to reflect the extra day needed to perform the endoscopic procedure as well as the interval between endoscopy and subsequent cholecystectomy. Accuracy for prediction of common bile duct pathology on the basis of preoperative laboratory tests and imaging techniques was 44%. This relative imprecision is consistent with results from other published studies: all of which indicate that the likelihood for common duct stones is prdportional to the number of positive preoperative risk factors [l-3]. One half of the patients in this trial who had endoscopic cholangiography were found to have normal cholangiograms and benefited from preoperative endoscopy only by elimination of the need for intraoperative cholangiography. This gain did not appear valuable nor was there an economic advantage for patients treated by
228
163
RESULTS
THE AMERICAN
JOURNAL
OF SURGERY
VOLUME
FEBRUARY
1992
PRECHOLECYSTECTOMY ENDOSCOPIC CHOLANGIOGRAPHY
TABLE II Results of Endoscopy/Operation Versus Operatlon Alone for Patients who Required Cholecystectomy and Had
Preoperative Suspicion of Common Duct Stones % Ducts
Hospital Stay
Cleared
Morbidity (%)
Mortality (99)
ERCSR
71
21
0
11.0
CC + CEDE
86
ia
0
9.2
Cohort
ERCSR = endoscopic No differences
retrograde
were statistically
cholangiography
(days)
Operating Room Time (min)
cost (dollars)
+ 1.5
114 _C 78
8,541
i
1,163
t
142
9,643
r
1,223
0.6
and stone removal: CC + CBDE = cholecystectomy,
cholangiography.
+ 72
and cwnmon
bile duct exploration.
significant.
endoscopic duct clearance as we had previously postulated [4]. Data from the current trial and another large prospective randomized study by Neoptolemos et al [5] confirm that precholecystectomy endoscopic cholangiography and stone removal is not superior to the traditional operative approach with regard to morbidity or mortality. The latter trial compared patients with confirmed common duct stones who were treated endoscopically followed by cholecystectomy with a well-matched cohort of patients who had confirmed duct stones (diagnosed by retrograde cholangiography) and who were treated by conventional cholecystectomy and common duct exploration. There were no statistically significant differences between cohorts but a trend toward higher complications in the endoscopic stone removal group was present in spite of the finding that patients in this group spent an average of five fewer days in hospital. In contrast, Heinerman et al [6’Jin a prospective but nonrandomized trial demonstrated a substantial reduction of morbidity in selected patients treated with endoscopic removal of common duct stones prior to elective cholecystectomy. In their study, 73 patients were diagnosed preoperatively as having common duct stones by retrograde cholangiography; however, 21 of these (29%) did not have endoscopic stone removal. Reasons for exclusion of these patients from the endoscopic treatment arm were not clearly delineated but appeared, as in the present study, to be related to the size of the common duct stones. Additional support for the endoscopic as opposed to open operative treatment of common duct stones is provided by two retrospective studies by Miller et al [7] and Worthley et al [8]. Roth showed that endoscopic treatment of common duct stones (predominately in patients with retained duct stones after cholecystectomy) was as successful as open operative duct exploration and was associated with less hospitalization time. The latter trial found significantly fewer complications in patients treated endoscopically. Long-term effects of endoscopic sphincterotomy are unknown. The incidence of stenosis of the endoscopically divided sphincter complex may range from 3% to as high as loo/o [9,10]. These data reflect results of endoscopic procedures performed largely on elderly patients; many of whom had failed one or more operations for treatment of recurrent or retained duct stones, and, therefore, these THE AMERICAN
data may not be applicable to the average patient who presents for cholecystectomy. Results of surgical sphincterotomy were studied by Ihre et al [II] who found no problems in 43 patients who were followed from 20 to 25 years. Similarly, Jones [12] reported no problems in 284 patients followed for 21 years after operative sphincteroplasty. It appears unlikely that significant late complications of endoscopic sphincterotomy will emerge although the theoretical possibility of very long-term effects resulting from alteration in bile salt metabolism remains [201. The present study was terminated in early 1990 because of the introduction of laparoscopic cholecystecto my. Optimal management of patients with suspected common duct stones who desire the minimal access operation has yet to be determined. We and others [13] have performed laparoscopic transcystic duct choledochoscopy with stone extraction at the time of laparoscopic cholecystectomy but this technique requires specialized equipment and may not be suitable in some patients, particularly those with small cystic ducts or low insertion of the cystic duct into the common bile duct. Laparosco pically performed cholecystectomy is now requested by virtually all patients at our institutions who require removal of the gallbladder. The current study has shown that endoscopic cholangiography and stone removal is neither superior nor inferior to conventional common duct exploration. Endoscopic cholangiography and stone clearance prior to performance of laparoscopic cholecystectomy in patients suspected of harboring common duct stones thus appears justified in order to avoid prolongation of the laparoscopic procedure with transcystic duct choledochoscopy or the necessity of converting the laparoscopic procedure into an open common bile duct exploration. In addition, preoperative endoscopic cholangiography will allow recognition of a small group of patients who may still be best treated by open common duct exploration instead of endoscopic sphincterotomy. It is generally acknowledged that endoscopic sphincterotomy, when performed in patients with small common ducts (less than 6 to 7 mm diameter), is associated with an increased risk of perforation and subsequent sub stantial morbidity and mortality [14,15]. This complication did not occur in the current study, but we believe that reliance upon endoscopic stone clearance techniques in patients with stones in small ducts is not desirable. Such
JOURNAL OF SURGERY
VOLUME
163
FEBRUARY
1992
229
tients with suspected duct stones who desire cholecystectomy by laparoscopic methods. REFERENCES
[email protected] rhoModd~iasis In whom perforpa-*mance of lapamwpic chdecystectomy is de&d.
patients may be better treated with conventional open cholecystectomy and duct exploration or, alternatively, if ductal anatomy is favorable and the facilities and personnel experienced in the technique are present, a planned laparoscopic duct exploration. Based on the current study and available literature we propose the algorithm shown in Figure 1 for management of suspected duct stones in the patient who requires elective cholecystectomy and desires avoidance of laparotomy. In conclusion, endoscopic cholangiography and stone removal prior to conventional elective cholecystectomy confer neither advantage nor disadvantage to patients so treated when compared with patients treated by open cholecystectomy, operative cholangiography, and common bile duct exploration. These findings confirm results from other trials and provide a rationale for performing endoscopic cholangiography and duct clearance in pa-
230
1. Hatter-Jensen M, Karesen R, Nygaard K, et al. Predictive ability of choledocholithiasis indicators. Ann Surg 1985; 202: 64-8. 2. Lacaine F, Corlette MB, Bismuth H. Preoperative evaluation of the risk of common duct stones. Arch Surg 1980; 115: 1114-6. 3. Saltzstein EC, Peacock JB, Thomas MD. Preoperative bilirubin, alkaline phosphatase and amylase levels as predictors of common duct stones. Surg Gynecol Obstet 1982; 154: 381-4. 4. Stiegmann GV, Pearlman NW, Goff JS, Sun JH, Norton LW. Endcscopic cholangiography and stone removal prior to cholecystectomy: a more cost-effectiveapproach than operative duct exploration? Arch Surg 1989; 124: 787-90. 5. Neoptolemos JP, Carr-Locke DL, Fossard DP. Prospective randomised study of preoperative endoscopic sphincterotomy versus surgery alone for common bile duct stones. BMJ 1987; 294: 470-4. 6. Heinerman PM, Boeckl 0, Pimp1 W. Selective ERCP and preoperative stone removal in bile duct surgery. Ann Surg 1989; 209: 267-72. 7. Miller BM, Kozarek RA, Ryan JA, Ball TJ, Traverso WT. Surgical versus endoscopic management of common bile duct stones. Ann Surg 1988; 207: 135-41. 8. Worthley CS, Watts JM, Toouli J. Common duct exploration or endoscopic sphincterotomy for choledocholithiasis. Aust N Z J Surg 1989; 59: 209-15. 9. Riemann JF, Lux G, Forster P, Altendof A. Long-term results after endoscopic papillotomy. Endoscopy 1983; 15: 165-8. 10. Cotton PB. Endcscopic management of bile duct stones; (apples and oranges). Gut 1984; 25: 587-97. 11. Ihre T, Lohn M, Kager L. Long-term effects of papillotomy. Endoscopy 1984; 16: 109-11. 12. Jones SA. Sphincteroplasty (not sphincterotomy) in the treatment of biliary tract disease. Surg Clin North Am 1973; 53: 1123-37. 13. Hunter JG. Laparoscopic transcystic common bile duct explo ration. Am J Surg 1992; 163: 53-8. 14. Bell RCW, Stiegmann GV, Goff JS, Reveille M, Norton LW, Pearlman N. Decision for surgical management of perforation following endoscopic sphincterotomy. Am Surg 1991; 57: 237-40. 15. Cotton PB, Baillie J, Pappas TN, Meyers WS. Laparcscopic cholecystectomy and the biliary endoscopist. Gastrointest Endosc 1991; 37: 94-6.
THE AMERICAN JOURNAL OF SURGERY VOLUME 163 FEBRUARY 1992
Thirty-four patients with suspected common bile duct stones were randomized to undergo endoscopic cholangiography and stone removal prior to open cholecystectomy or to have open cholecystectomy, operative cholangiography, and common bile duct exploration. Sixteen underwent the first protocol, and 18 the second. Analysis of the ability to clear stones from the common bile duct, morbidity, mortality, hospital stay, length of operation, and hospital cost showed no difference in outcome between patients treated by either method. These data suggest there is neither an advantage nor a disadvantage to treating patients with suspected duct stones by precholecystectomy endoscopic cholangiography and stone removal.
MD,
0 surgical treatment scopic cholangiography,
perative common bile duct exploration is standard for choledocholithiasis. Endosphincterotomy, and stone removal is also effective for the removal of common bile duct stones but, in North America, has been employed primarily in patients with retained or recurrent duct stones following cholecystectomy or in those not considered lit for laparotomy. The purpose of this study was to compare operative common duct exploration with preoperative endoscopic treatment of common duct stones in patients who required elective cholecystectomy and had laboratory and/or ultrasound abnormalities suggesting the presence of common duct stones. PATIENTS AND METHODS
From June 1986 to March of 1990, 34 patients who required elective cholecystectomy and were suspected of harboring common duct stones were randomized to undergo either operative or combined endoscopic and operative treatment. Patients with ascending cholangitis and those who underwent operation for acute cholecystitis were excluded as were those with underlying liver disease, bleeding disorders, previous gastric surgery precluding endoscopic examination of the bile duct, and those who had prior biliary tract operations. Risk factors for the suspicion of choledocholithiasis preoperatively included any one or more of the following criteria: serum bilirubin (total) greater than 2 mg/dL (two times normal), serum alkaline phosphatase greater than 235 IU/L (two times normal), serum amylase greater than 240 U/L (two times normal), ultrasound bile duct greater than 8 mm diameter, and ultrasound bile duct showing stone in duct. Serum amylase was employed as a criterion only in patients in whom elevation persisted to within 24 hours of operation or endoscopy. Randomization was done by drawing sealed envelopes that contained computer-generated random assignments. The operation-only cohort had conventional open cholecystectomy with intraoperative cholangiography (two views) and common duct exploration if the cholangiogram confirmed the presence of duct stones. Duct exploFromthe Dcnartments of SurgervKWS.AM.NP. LN1andMedicine ration was performed in conventional fashion, and chole(JSG,RMR’),Universityof r?o&do and Dekver’VeteransAdminisdochoscopy was employed at the discretion of the trationHospitals,Denver,Colorado. Requestsfor reprints should be addressed to Greg V. Stiegmann, operating surgeon. Operation was accomplished as soon MD,UCHSC,BoxC-313,4200East9th Avenue,Denver,Colorado after randomization as the elective operating schedule 80262. tinted as a posterpaperat the 32ndAnnualMeetingof the allowed. Patients in the endoscopicloperative group had societyfor Surgery of the Alimentary Tract, New Orleans, Louisiana, endoscopic cholangiography followed by sphincterotomy May 20-22, 1991. and stone removal if stones were seen on the endoscopic THE AMERICAN JOURNAL OF SURGERY
VOLUME 163 FEBRUARY 1992
227
STIEGMANN ET AL
TABLE
I
Preoperatlve Variables in Endoscopic/Operative and Operative Only Patlents Variable
Endo/Op
(n = 16)
Op Only (n = 18)
Age (years)
46.3 + 21.7
38.1 f 14.8
Weight (kg)
72 + 20.4
74.7 2 23.2
4.36 2 2.62
3.18 * 3.00
Bilirubin (mg/dL) Alkaline Phosphate (lull)
469 + 250
506 2 350
Amylase (U/L)
178 f 243
375 + 668
Dilated duct (US)
6116
6118
Stone in duct (US)
l/16
3118
All values are mean values f standard deviation of the mean. EndolOp = endoswpic cholangiography and stone removal prior to operative open cholacystectomy; Op = operation only; (US) = as determined by preoperative uRrasound. No differences were statistically significant.
cholangiogram. Endoscopic procedures were scheduled when possible to allow performance of cholecystectomy the following day. The operation-only cohort was assessed for the ability of the surgeon to clear the common duct of stones as judged by postoperative t-tube cholangiography performed 10 or more days following operation. The endostopic/operative group was assessed for the ability of the endoscopist to clear the common duct of stones as determined by retrograde cholangiography at the time of endoscopy and at operative cholangiography thereafter if the operating surgeon or endoscopist felt an additional cholangiogram was indicated. Morbidity was defined as any untoward event that required active treatment or prolonged hospitalization. Hospital charges were ob tained directly from the hospital finance office and reflected the total hospital (nonprofessional) bill the patient received for the admission. This study was approved by the investigational review board of our hospitals, and all patients gave informed consent. Statistical analysis was by chi square and Student’s ttest with significance defined at p <0.05.
operative exploration and only achieved duct clearance with radiologically guided stone extraction via the t-tube tract. An additional patient who had successful endoscopic duct clearance was observed during manipulation of the gallbladder at operation to pass a stone from the cystic duct into the common duct. Duct exploration was required to clear the common duct. All other patients with the exception of the one with cholangiocarcinoma diagnosed at endoscopic cholangiography and an additional patient found to have advanced cirrhosis at laparotomy had uneventful open cholecystectomy. Both of the latter patients were excluded from further analysis. The mean interval between endoscopy and cholecystectomy was 1.6 (0 to 5) days. Seven of the 18 patients treated by operation only were found to have common duct stones and had operative common duct exploration in addition to cholecystectomy. Four of these required transduodenal sphincteroplasty for removal of stones impacted in the ampulla. One of the seven had a retained stone that was removed radiologically via the t-tube tract. Complications in both cohorts only occurred after operation and included minor wound infections, ileus, bile fistula, and postoperative fevers. None of the complications were directly attributable to the endoscopic procedure, and all resolved without operative intervention. Results with regard to morbidity, overall hospital stay, and costs are summarized in Table II.
Independent analysis of the patients in both cohorts who had common duct stones showed no statistically significant differences in mean hospital stay, morbidity, or cost between these two subgroups. No correlation with age and the presence or absence of choledocholithiasis was present in these patients. COMMENTS
Sixteen patients were randomized to endoscopy followed by operation and 18 to operation alone. Characteristics of the two cohorts are presented in Table I. All patients in the endoscopic/operation arm had successful endoscopic cholangiography. Eight (50%) had positive findings including stones (7) and cholangiocarcinoma (1). The remaining eight had normal endoscopic cholangiograms. Stones were successfully removed endoscopitally in five of the seven patients (71%). One of the five required two endoscopic procedures. Two additional patients failed to achieve duct clearance with the endoscopic technique because of the large size of common duct stones. Both had operative duct exploration at the time of cholecystectomy. One patient had retained stones after
This study indicates that performance of endoscopic retrograde cholangiography and stone removal prior to open cholecystectomy in patients suspected of harboring common duct stones is not superior to conventional open cholecystectomy, operative cholangiography, and common bile duct exploration. Endoscopic cholangiography and removal of duct stones prior to cholecystectomy resulted in an overall increase in hospitalization (mean: 2.2 days) when compared with operation alone. This increase appeared to reflect the extra day needed to perform the endoscopic procedure as well as the interval between endoscopy and subsequent cholecystectomy. Accuracy for prediction of common bile duct pathology on the basis of preoperative laboratory tests and imaging techniques was 44%. This relative imprecision is consistent with results from other published studies: all of which indicate that the likelihood for common duct stones is prdportional to the number of positive preoperative risk factors [l-3]. One half of the patients in this trial who had endoscopic cholangiography were found to have normal cholangiograms and benefited from preoperative endoscopy only by elimination of the need for intraoperative cholangiography. This gain did not appear valuable nor was there an economic advantage for patients treated by
228
163
RESULTS
THE AMERICAN
JOURNAL
OF SURGERY
VOLUME
FEBRUARY
1992
PRECHOLECYSTECTOMY ENDOSCOPIC CHOLANGIOGRAPHY
TABLE II Results of Endoscopy/Operation Versus Operatlon Alone for Patients who Required Cholecystectomy and Had
Preoperative Suspicion of Common Duct Stones % Ducts
Hospital Stay
Cleared
Morbidity (%)
Mortality (99)
ERCSR
71
21
0
11.0
CC + CEDE
86
ia
0
9.2
Cohort
ERCSR = endoscopic No differences
retrograde
were statistically
cholangiography
(days)
Operating Room Time (min)
cost (dollars)
+ 1.5
114 _C 78
8,541
i
1,163
t
142
9,643
r
1,223
0.6
and stone removal: CC + CBDE = cholecystectomy,
cholangiography.
+ 72
and cwnmon
bile duct exploration.
significant.
endoscopic duct clearance as we had previously postulated [4]. Data from the current trial and another large prospective randomized study by Neoptolemos et al [5] confirm that precholecystectomy endoscopic cholangiography and stone removal is not superior to the traditional operative approach with regard to morbidity or mortality. The latter trial compared patients with confirmed common duct stones who were treated endoscopically followed by cholecystectomy with a well-matched cohort of patients who had confirmed duct stones (diagnosed by retrograde cholangiography) and who were treated by conventional cholecystectomy and common duct exploration. There were no statistically significant differences between cohorts but a trend toward higher complications in the endoscopic stone removal group was present in spite of the finding that patients in this group spent an average of five fewer days in hospital. In contrast, Heinerman et al [6’Jin a prospective but nonrandomized trial demonstrated a substantial reduction of morbidity in selected patients treated with endoscopic removal of common duct stones prior to elective cholecystectomy. In their study, 73 patients were diagnosed preoperatively as having common duct stones by retrograde cholangiography; however, 21 of these (29%) did not have endoscopic stone removal. Reasons for exclusion of these patients from the endoscopic treatment arm were not clearly delineated but appeared, as in the present study, to be related to the size of the common duct stones. Additional support for the endoscopic as opposed to open operative treatment of common duct stones is provided by two retrospective studies by Miller et al [7] and Worthley et al [8]. Roth showed that endoscopic treatment of common duct stones (predominately in patients with retained duct stones after cholecystectomy) was as successful as open operative duct exploration and was associated with less hospitalization time. The latter trial found significantly fewer complications in patients treated endoscopically. Long-term effects of endoscopic sphincterotomy are unknown. The incidence of stenosis of the endoscopically divided sphincter complex may range from 3% to as high as loo/o [9,10]. These data reflect results of endoscopic procedures performed largely on elderly patients; many of whom had failed one or more operations for treatment of recurrent or retained duct stones, and, therefore, these THE AMERICAN
data may not be applicable to the average patient who presents for cholecystectomy. Results of surgical sphincterotomy were studied by Ihre et al [II] who found no problems in 43 patients who were followed from 20 to 25 years. Similarly, Jones [12] reported no problems in 284 patients followed for 21 years after operative sphincteroplasty. It appears unlikely that significant late complications of endoscopic sphincterotomy will emerge although the theoretical possibility of very long-term effects resulting from alteration in bile salt metabolism remains [201. The present study was terminated in early 1990 because of the introduction of laparoscopic cholecystecto my. Optimal management of patients with suspected common duct stones who desire the minimal access operation has yet to be determined. We and others [13] have performed laparoscopic transcystic duct choledochoscopy with stone extraction at the time of laparoscopic cholecystectomy but this technique requires specialized equipment and may not be suitable in some patients, particularly those with small cystic ducts or low insertion of the cystic duct into the common bile duct. Laparosco pically performed cholecystectomy is now requested by virtually all patients at our institutions who require removal of the gallbladder. The current study has shown that endoscopic cholangiography and stone removal is neither superior nor inferior to conventional common duct exploration. Endoscopic cholangiography and stone clearance prior to performance of laparoscopic cholecystectomy in patients suspected of harboring common duct stones thus appears justified in order to avoid prolongation of the laparoscopic procedure with transcystic duct choledochoscopy or the necessity of converting the laparoscopic procedure into an open common bile duct exploration. In addition, preoperative endoscopic cholangiography will allow recognition of a small group of patients who may still be best treated by open common duct exploration instead of endoscopic sphincterotomy. It is generally acknowledged that endoscopic sphincterotomy, when performed in patients with small common ducts (less than 6 to 7 mm diameter), is associated with an increased risk of perforation and subsequent sub stantial morbidity and mortality [14,15]. This complication did not occur in the current study, but we believe that reliance upon endoscopic stone clearance techniques in patients with stones in small ducts is not desirable. Such
JOURNAL OF SURGERY
VOLUME
163
FEBRUARY
1992
229
tients with suspected duct stones who desire cholecystectomy by laparoscopic methods. REFERENCES
[email protected] rhoModd~iasis In whom perforpa-*mance of lapamwpic chdecystectomy is de&d.
patients may be better treated with conventional open cholecystectomy and duct exploration or, alternatively, if ductal anatomy is favorable and the facilities and personnel experienced in the technique are present, a planned laparoscopic duct exploration. Based on the current study and available literature we propose the algorithm shown in Figure 1 for management of suspected duct stones in the patient who requires elective cholecystectomy and desires avoidance of laparotomy. In conclusion, endoscopic cholangiography and stone removal prior to conventional elective cholecystectomy confer neither advantage nor disadvantage to patients so treated when compared with patients treated by open cholecystectomy, operative cholangiography, and common bile duct exploration. These findings confirm results from other trials and provide a rationale for performing endoscopic cholangiography and duct clearance in pa-
230
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THE AMERICAN JOURNAL OF SURGERY VOLUME 163 FEBRUARY 1992