Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Endoscopic balloon dilatation is a safe method in the management of common bile duct stones. Endoscopic papillary balloon dilation and endoscopic sphincterotomy for bile duct stones: long-term outcomes in a prospective randomized controlled trial. Endoscopic sphincterotomy and endoscopic papillary balloon dilatation for bile duct stones: A prospective randomized controlled multicenter trial. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bileduct stones. A randomized trial of endoscopic balloon dilation and endoscopic sphincterotomy for removal of bile duct stones in patients with a prior Billroth II gastrectomy. Endoscopic balloon dilatation versus endoscopic sphincterotomy for the removal of bile duct stones: a prospective randomised trial. Endoscopic papillary balloon dilation vs. sphincterotomy for removal of common bile duct stones: a prospective randomized pilot study. Papillary dilation vs sphincterotomy in endoscopic removal of bile duct stones. A randomized trial with manometric function. What is an appropriate indication for endoscopic papillary balloon dilation? Comparing the treatment outcomes of endoscopic papillary dilation and endoscopic sphincterotomy for removal of bile duct stones. Can endoscopic papillary balloon dilation really preserve sphincter of Oddi function?
Endoscopic retrograde cholangiopancreatography is commonly performed to remove bile duct stones. The aim of this study was to determine short-term outcomes of endoscopic balloon dilation of the sphincter of Oddi compared with sphincterotomy for stone extraction.
                A randomized, controlled multicenter study of 117 patients assigned to dilation and 120 to sphincterotomy was performed in a spectrum of clinical and academic practices.
                Characteristics of the patients, procedures, and endoscopists were similar except that dilation patients were younger. Procedures were successful in 97.4% and 92.5% of the dilation and sphincterotomy patients, respectively. Overall morbidity occurred in 17.9% and 3.3% ( P < .001; difference, 14.6; 95% confidence interval, 7-22.3) and severe morbidity, including 2 deaths, in 6.8% and 0%( P < .004; difference, 6.8; 95% confidence interval, 2.3-11.4) for dilation and sphincterotomy, respectively. Complications for dilation and sphincterotomy, respectively, included: pancreatitis, 15.4% and .8% ( P < .001; difference, 14.6; 95% confidence interval, 7.8-21.3); cystic duct fistula, 1.7% and 0%; cholangitis, .9% and .8%; perforation, 0% and .8%; and cholecystitis, 0% and .8%. There were 2 deaths (1.7%) due to pancreatitis following dilation and none with sphincterotomy. The study was terminated at the first interim analysis. Dilation patients required significantly more invasive procedures, longer hospital stays, and longer time off from normal activities.
                In a broad spectrum of patients and practices, endoscopic balloon dilation compared with sphincterotomy for biliary stone extraction is associated with increased short-term morbidity rates and death due to pancreatitis. Balloon dilation of the sphincter of Oddi for stone extraction should be avoided in routine practice. Endoscopic sphincterotomy is a widely accepted treatment for patients with common bile duct stones. Despite improvement in this technique, endoscopic sphincterotomy is still associated with some biliary complications. Endoscopic balloon dilatation is a less traumatic and sphincter preserving method for removal of common bile duct stones. However, the results of controlled studies in comparison with these two methods are contradictory. The aim of this study is to compare the safety and efficacy of endoscopic balloon dilatation and endoscopic sphincterotomy in Chinese patients.
                A total of 104 patients with common bile duct stones on endoscopic retrograde cholangiopancreatography were enrolled. They were randomly assigned to endoscopic balloon dilatation or endoscopic sphincterotomy. Endoscopic balloon dilatation was performed by using a balloon dilator to dilate the sphincter for 5 min. The common bile duct stones were then removed by a Dormia basket after endoscopic balloon dilatation or endoscopic sphincterotomy. Mechanical lithotripsy was performed if the stones were difficult to remove by Dormia basket. After discharge, patients were regularly followed up for biliary complications.
                The successful bile duct stone clearance rate was 94.1% in endoscopic balloon dilatation group and 100% in endoscopic sphincterotomy group. Post-procedural significant haemorrhage was higher in endoscopic sphincterotomy group than in endoscopic balloon dilatation group (14/53 versus 1/48, P < 0.001). The bleeding patient from endoscopic balloon dilatation group was a case of uremia and bleeding occurred 48 h after endoscopic balloon dilatation. All the patients with post-procedural haemorrhage were controlled endoscopically. The post-procedural serum amylase level showed no significant difference in both groups and none of them developed clinical pancreatitis. After a mean 16 months follow-up, three patients (6.3%) in endoscopic balloon dilatation group and four patients (7.5%) in endoscopic sphincterotomy group developed recurrent common bile duct stones. The recurrent common bile duct stones were multiple and muddy in consistency. They were successfully removed endoscopically.
                Both endoscopic balloon dilatation and endoscopic sphincterotomy are safe and effective techniques for the treatment of common bile duct stones. Endoscopic balloon dilatation can be safely applied in patients with coagulopathy and does not increase the incidence of pancreatitis or bleeding. Little is known about the long-term outcome of endoscopic papillary balloon dilation for removal of bile duct stones. A randomized trial that compared long-term outcomes after endoscopic papillary balloon dilation and endoscopic sphincterotomy was conducted.
                Thirty-two patients with bile duct stones were randomized to endoscopic papillary balloon dilation or endoscopic sphincterotomy, with 16 patients in each group. Endoscopic papillary balloon dilation was performed by using an 8-mm-diameter balloon; endoscopic sphincterotomy was performed in the standard manner. The success rates for stone removal, as well as the frequency and types of early (<15 days), mid-term (<1 year), and long-term (1-6 years) post-procedure complications were evaluated.
                The success rates for stone removal and early complication rates were similar for both groups. The frequency of stone recurrence was approximately 4-fold higher in the endoscopic papillary balloon dilation group (25%) vs. the endoscopic sphincterotomy group (6.3%) at mid-term evaluation. However, over the long term, Kaplan-Meier estimated probability of stone recurrence tended to be higher in the endoscopic sphincterotomy group vs. the endoscopic papillary balloon dilation group; recurrent stones were found in, respectively, 26.7% vs. 6.3%. Complications occurred in 7 patients in each group.
                Long-term outcome of endoscopic papillary balloon dilation for bile duct stone removal is satisfactory, provided that consideration is given to recurrence of stones by early follow-up evaluation. Endoscopic papillary balloon dilatation may be an alternative to endoscopic sphincterotomy in the treatment of bile duct stones. However, there is a controversy as to the effectiveness and safety of endoscopic papillary balloon dilatation.
                Two hundred eighty-two patients with bile duct stones were enrolled and randomized to an endoscopic sphincterotomy or endoscopic papillary balloon dilatation group. The success rate for duct clearance as well as the frequency and types of complications were evaluated prospectively. Endoscopic sphincterotomy was performed in a standard manner. Endoscopic papillary balloon dilatation was carried out with gradual inflation of a 4-, 6-, or 8-mm diameter balloon.
                Complete duct clearance was achieved in 100% in the endoscopic sphincterotomy group and 99.3% in the endoscopic papillary balloon dilatation group (not significant). Complications occurred in 11.8% of patients in the endoscopic sphincterotomy group and 14.5% of those in the endoscopic papillary balloon dilatation group (not significant). No complication was severe; there was no mortality. The frequency of acute pancreatitis was higher in the endoscopic papillary balloon dilatation group than the endoscopic sphincterotomy group (respectively, 10.9% vs. 2.8%; p < 0.045). Hemorrhage occurred only in the endoscopic sphincterotomy group.
                Endoscopic sphincterotomy and endoscopic papillary balloon dilatation were approximately equal in terms of successful clearance of bile duct stones. They were also similar with respect to overall complications. Endoscopic papillary balloon dilatation is an alternative to endoscopic sphincterotomy as a treatment of bile duct stones. Endoscopic sphincterotomy (EST) for the removal of bileduct stones is associated with acute complications and a permanent loss of biliary-sphincter function. Endoscopic balloon dilation (EBD) causes less trauma to the biliary sphincter, but may be less effective in allowing stone removal.
                218 consecutive patients with bileduct stones on endoscopic retrograde cholangiopancreatography (ERCP) were enrolled. 202 who met all eligibility criteria were randomly assigned EST or EBD. The patients were observed in hospital for at least 24 h and followed up at 1 month and 6 months. Complications were classified by an expert panel unaware of treatment allocation and outcome. Analysis was done by intention to treat.
                After a single ERCP, all stones were removed from 92 (91%) of 101 patients assigned EST and 90 (89%) of 101 assigned EBD (p = 0.81); in nine of the latter, successful removal required additional EST. Mechanical lithotripsy was used to fragment stones in 31 EBD procedures and 13 EST procedures (p < 0.005). Early complications (before 15 days) occurred in 24 EST patients and 17 EBD patients (p = 0.29). One patient died of retroperitoneal perforation after EBD. Four patients had bleeding after EST. Seven patients in each group had pancreatitis. Complications during follow-up occurred in 23 EST patients and 18 EBD patients (p = 0.48). Acute cholecystitis was observed in seven EST patients and one EBD patient (p < 0.05).
                The success rate of EBD was similar to that of EST. We found there is no evidence of the previously suggested higher risk of pancreatitis with EBD and suggest that EBD is preferred in patients at risk of bleeding after EST. Preservation of biliary-sphincter function after EBD may prevent long-term complications and reduce the risk of acute cholecystitis during follow-up. This procedure is a valuable alternative to EST in patients with bileduct stones. A prior Billroth II gastrectomy renders endoscopic sphincterotomy (EST) more difficult in patients with bile duct stones. Endoscopic balloon dilation (EBD) is a relatively easy procedure that potentially reduces the risk of bleeding and perforation.
                Thirty-four patients with bile duct stones and a previous Billroth II gastrectomy were randomized to EST or EBD. Complications were graded in a blinded fashion. Results were compared with those for a group of 180 patients with normal anatomy from a previously reported randomized trial of EBD versus EST.
                All stones were removed in 1 endoscopic retrograde cholangiopancreatography in 14 of 16 patients who underwent EBD versus 14 of 18 who had EST (p = 1.00). Mechanical lithotripsy was used in 3 EBD procedures versus 4 EST procedures (p = 1.00). Early complications occurred in 3 patients who had EBD versus 7 who underwent EST (p = 0.27). Three patients had bleeding after EST; 1 patient had mild pancreatitis after EBD. The median time required for stone removal was 30 minutes in both groups. Compared with patients with a normal anatomy, patients with a previous Billroth II gastrectomy had a significantly increased risk of bleeding after EST (17% vs. 2%, relative risk = 7.25, p < 0.05).
                A prior Billroth II gastrectomy renders EST more difficult and increases the risk of a complication. EBD in these patients is easy to perform and is not associated with an increased need for mechanical lithotripsy or a longer procedure time. The risk of bleeding is virtually absent after EBD and the risk of pancreatitis after EBD seems not significantly increased in these patients. Endoscopic balloon dilatation (EBD) of the sphincter of Oddi has been proposed as an alternative therapy with possible advantages, as compared with endoscopic sphincterotomy (ES), for removal of bile duct stones.
                In a randomised study, we compared the efficacy and complication rate of the two techniques in 202 patients with common bile duct stones. Patients were followed up for 12 months.
                A total of 103 patients were randomised to the EBD group and 99 to the ES group. Overall duct clearance was 87.1% and did not differ between the two groups (EBD 87.4%; ES 86.9%). The complication rate at 24 hours was 6.8% in the EBD group and 3.0% in the ES group (NS). Complications during follow up were 11.7% and 15.2% respectively (NS). A multivariate logistic regression analysis showed only the size of the largest stone to be predictive of success for either technique.
                Endoscopic balloon dilatation offers no significant advantage over the well established technique of endoscopic sphincterotomy for the removal of bile duct stones. Endoscopic sphincterotomy (EST) is the standard procedure for gaining access to the common bile duct for removal of bile duct stones. However, the procedure is associated with both short-term and long-term complications. Recent reports have described the use of endoscopic papillary balloon dilation (EBD) as an effective and safe alternative to EST. We conducted a prospective randomized pilot study to compare the efficacy and short-term complication rates of these two established methods for removing uncomplicated bile duct stones.
                Sixty patients were randomly assigned to receive either EST (n = 30) or EBD (n = 30) prior to removal of bile duct stones (maximum size 20 mm, maximum number five). The patient groups were comparable with regard to sex and age ratios, the size of the stones (EST: mean 10 +/- 4.7 mm; EBD: mean 7 +/- 3.5 min; not significant) and the numbers of stones (EST: mean 1.8 +/- 1.5 mm; EBD: mean 1.6 +/- 1.1 mm; not significant). EBD was carried out using a balloon-tipped biliary catheter (Maxforce, Microvasive, Boston, Massachusetts, USA) with a maximum diameter of 24 Fr for 45-60 s. Bile duct stones were removed using Dormia baskets or retrieval balloons, or both.
                The two methods were successful in all patients studied. Subsequent stone removal was possible in all 30 patients after EST (100%) and in 23 of the 30 who underwent EBD (77%), respectively (P<0.01). After conversion to EST, complete bile duct clearance was also achieved in the remaining seven EBD patients. The mean duration for the whole procedure was 17 +/- 12 min for EST and 29 +/- 15 min for EBD (not significant). Complications (WHO grades 2-4) were observed in five of the 30 EST patients (three cases of mild pancreatitis, two of hemorrhage) and in nine of the 30 EBD patients (three cases of cholangitis, four of mild pancreatitis, and two of severe pancreatitis), showing a trend toward higher complication rates in the EBD group. Postintervention hyperamylasemia was observed in six patients (three in each group).
                The results of this prospective randomized pilot study indicate that EST is superior to EBD in terms of stone removal, duration of the procedure, and complication rates. EST will therefore continue to be the standard procedure for stone removal in the near future. Further studies will be needed in order to compare the longer-term results with EST and EBD. To circumvent the long-term effects of papillary ablation for extracting common bile duct stones (< 12 mm in diameter) in endoscopic sphincterotomy (EST), endoscopic papillary dilation (EPD) was attempted in 20 patients. To evaluate papillary function before and after the procedures, manometry of the sphincter of Oddi was carried out in 13 with EPD and 10 of 20 patients with EST. Extraction of all stones was successful (100%) in both groups at an equal rate. Repeated numbers of procedures were common in both groups. However, the mean duration of the procedure was high in EPD compared to EST (63 min vs 42 min, P < NS). Adjunctive therapies like mechanical lithotripsy (ML), nasobiliary drainage, and choledochoscopy were included in EPD, while EST required a basket catheter and ML. There was no significant difference on manometry before and after the procedures (P = NS), although papillary function was found to have decreased after the EPD. In contrast, all patients in the EST group lost papillary function after the procedure. Thirty-day morbidity and mortality rate were absent in both groups. Immediate and 2.5-year follow up complications were uncommon in both groups. As a simple method, EPD may be an effective and safe alternative to EST in the management of patients with bile duct stones who require maintenance of papillary function. There are a number of views on the indication for endoscopic papillary balloon dilation (EPBD) in the management of bile duct stones. In this study, we have evaluated the efficacy and safety of EPBD compared with endoscopic sphincterotomy (EST).
                Prospective randomized trial.
                One university hospital and one general hospital.
                One hundred and forty patients were randomly allocated to EPBD or EST. Outcomes and complications were observed for a median period of 30 months.
                Both treatment approaches finally achieved similar success rates and needed similar numbers of treatment sessions for patients with stones less than 10 mm in diameter. However, for patients with stones of 10 mm or more, EPBD required a significantly greater mean number of treatment sessions than EST (2.4 vs 1.6, P < 0.01). Early complications occurred in seven EPBD (four pancreatitis, two cholangitis and one basket impaction) and eight EST (three pancreatitis, two bleeding and three cholangitis) patients. Late complications occurred in four EPBD (three recurrent bile duct stones and one cholecystitis) and six EST (three recurrent stones and three cholecystitis) patients.
                EPBD has little risk of bleeding. The technique removed small bile duct stones just as easily as did EST. These two procedures had approximately the same risk of pancreatitis and incidence of recurrent bile duct stones. Therefore, both procedures appear to be appropriate treatments for small bile duct stones. Whether or not EPBD becomes an established treatment will depend on further long-term studies. To compare the clinical usefulness of endoscopic papillary dilation (EPD) and endoscopic sphincterotomy (EST) for removal of bile duct stones, 110 patients with stones up to 15 mm in diameter and less than 10 in number were randomly treated with either EPD (55 patients) or EST (55 patients). The patients were followed up for a median period of 23 months and endoscopic manometry with the administration of morphine was carried out in 17 patients who were observed more than 12 months after the procedures to evaluate the post-procedure papillary function. Duct clearance was achieved in 51 EPD (92.7%) and 54 EST patients (98.1%, not significantly different). Forty EPD (78.4%) and 51 EST patients (94.4%) achieved duct clearance in the initial procedure (P=0.02). Early complications occurred in one EPD (2.0%) and in three EST patients (5.6%, P=0.62). Complications during the follow-up period occurred in two EPD and eight EST patients. Recurrence of bile duct stones was observed in two EPD and three EST patients (P=0.98). Acute cholecystitis was observed in one EPD and five EST patients (P=0.06) and among patients with gall-bladder stones in situ, the rate of acute cholecystitis after EPD was significantly lower than that after EST (P=0.03). Endoscopic manometry showed the existence of a choledochoduodenal pressure gradient only after EPD, while papillary contractile function was observed after both procedures. In conclusion, both EPD and EST are safe therapeutic modalities, although EPD is more clinically effective in decreasing the risk of acute cholecystitis in patients with gall-bladder stones in situ and in preserving post-procedure papillary function. Endoscopic papillary balloon dilation (EPBD) is assumed to preserve sphincter of Oddi function because it causes little trauma to the papilla. However, few studies have addressed this issue specifically. In this study, we investigated whether EPBD can preserve sphincter function, and evaluated whether or not such preservation has clinical significance.
                Seventy patients with common bile duct (CBD) stones were randomly assigned to EPBD or endoscopic sphincterotomy (EST). Sphincter of Oddi (SO) function was measured by endoscopic manometry before, one week after, and one year after treatment. Incidence of pneumobilia and later complications were compared between the two groups at one year. Series manometric data were compared within each group and between the two groups. For a more detailed analysis of the cumulative incidence of later complications, retrospective cohorts were added to the study groups, giving a total number of 235 patients in the EPBD group and 126 in the EST group.
                Baseline characteristics did not differ significantly between the 35 EPBD and 35 EST patients. CBD stones were discharged successfully in all cases. CBD pressure, SO basal and peak pressures, and contraction frequency decreased significantly at one week in both groups. The damage was more severe in the EST group, and SO contraction completely disappeared in 23 patients in this group. The incidence of pneumobilia was significantly lower in the EPBD group than in the EST group (p<0.01) whereas CBD stones recurred and cholecystitis appeared at a similar rate in both groups at one year. A complete series of manometric data up to one year was obtained in 55 patients; 28 in the post-EPBD and 27 in post-EST groups. In the post-EPBD group, SO basal and peak pressures significantly recovered at one year compared with data at one week but these measures still remained significantly lower than those before EPBD (p< 0.01). In the post-EST group, SO contraction did not recover even after one year. A Kaplan-Meier analysis of 235 EPBD and 126 EST patients for a median follow up of 37 months revealed significantly lower incidences of biliary complications such as recurrent CBD stones and cholangitis, and cholecystitis in the EPBD group than in the EST group (p<0.05). The risk of pneumobilia was also significantly lower in the EPBD group (p<0.01).
                Preservation of papillary function after EPBD was not complete but remained somewhat reduced. However, preservation was more successful with EPBD than with EST. Such preservation may be clinically beneficial for the prevention of later complications.
Endoscopic balloon dilation is slightly less successful than endoscopic sphincterotomy in stone extraction and more risky regarding pancreatitis. However, endoscopic balloon dilation seems to have a clinical role in patients who have coagulopathy, who are at risk for infection, and possibly in those who are older.