| Objective:Through randomized controlled clinical trials and long-term follow-up study ,evaluate the effectiveness and safety of small incision combined with large papillary balloon dilatation (EST-EPLBD) in young patients with common bile duct stones (diameter larger than 10mm ).Compare the incidence of short - term complications such as postoperative hemorrhage, acute pancreatitis, common bile duct stone recurrence and long-term complications such as recurrent calculus, cholangitis, recurrent pancreatitis of two groups ,observe the efficacy and safety of small incision with papillary balloon dilation in treatment of intractable common bile duct stones in youth; evaluate the recurrence of common bile duct stones and identify risk factors for recurrence following small-incision endoscopic sphincterotomy (EST) with and without endoscopic large papillary balloon dilation (EPLBD); provide the basis for endoscopic retrograde cholangio-pancreatography (ERCP).Methods:Three hundred patients with common bile duct stone who were hospitalized at our institution between June 2007 and June 2008 were included in our study.The patients complained of abdominal pain, fever; 184 male cases, 116 female cases, Using the random number table method, 148 patients were randomly assigned to the EST group, and 152 patients were assigned to the EST-EPBD group. Only patients age from 18 to 45years who had been diagnosed with large (> 10 mm in diameter) common bile duct stones using ultrasound, computed tomography (CT), or nuclear magnetic resonance cholangiopancreatography were included in our study. All patients were hospitalized, use antibiotics after operation.The procedures were performed using an Olympus type JF260V or JF240 electronic duodenoscope, Boston catheter, yellow zebra guide wire, super-smooth guide wire, duodenal papilla knife (Boston), CRE balloon catheter 5.5cm (balloon 12.0-13.5-15.Omm and 15.0-16.5-18.0mm),mechanical lithotripsy (ML), stone basket or stone balloon, and an electronic surgical workstation. Patients received diazepam sedation or general anesthesia using propofol before intubation. The EST procedure was performed using a 10- to 15-mm incision in the duodenal papilla, and EPLBD was performed using a 3- to 5-mm incision, that was less than one-third of the diameter of the of the duodenal nipple at the highest point. The balloon type was selected based on the diameter of the common bile duct and the size of the stones. Mechanical lithotripsy was used for difficult-to-remove stones. Lastly, balloon occlusion angiography was performed to confirm the removal of the stone. Conventional nasobiliary drainage was provided postoperatively for all of the patients, and the absence of residual stones was confirmed 2 days after surgery. When stones were detected postoperatively or nasobiliary drainage failed to release bile, ERCP was repeated or transabdominal surgery was performed 1 to 2 months later.Recording the largest diameter of common bile duct stone, number of stones, operation time, one-time stone clearance rate, the total stone clearance rate, incidence of complications..Patients were hospitalized for at least 2 days after ERCP to prevent complications.The serum level of amylase was measured at 3 and 12 h postsurgery for each patient. Complications and clinical outcomes were evaluated according to the standards established by Cotton. Clinical follow-up examinations were performed at 1,3, and 6 months postsurgery. Abdominal CT and blood biochemical analysis were performed at least every 6 months. Patients were contacted by telephone over the course of the long-term follow-up. Patients suffering abdominal pain, those who were jaundice, and those with other severe symptoms were admitted to the hospital for further evaluation. The statistical analysis of the data was performed using the SPSS, version 16.0, statistical software. The results are reported as the mean ± standard deviation. Intergroup differences in the data were compared using two-tailed t-tests, and potential risk factors for the recurrence of common bile duct stone were evaluated using a logistic regression analysis. The level of statistical significance was set at P<0.05.Results:A total of 291 patients completed the study. The overall success rates for the EST-EPLBD and EST groups were 97.1% and 94%, respectively (P>0.05). The incidence of acute pancreatitis of The EST-EPLBD group and EST group were 7.14%, 6.25%, the difference was not statistically significant (P> 0.05), bleeding rate of EST group was 7.29%, the EST -EPLBD group was 1.02%, the difference was statistically significant (P< 0.05), the recent common bile duct stone recurrence rate (11.5%) of EST group was higher than that of EST-EPLBD group (7.16%), the difference was not statistically significant (P> 0.05). the recurrent pancreatitis incidence rate of the EST-EPLBD group and EST group were 0%, 2.08%, the difference was statistically significant (P< 0.05), reflux cholangitis occurrence rate of EST group is 8.33%, the EST -EPLBD group was 2.04%, the difference was statistically significant (P< 0.05), long-term common bile duct stone recurrence rate (8.6%) of the EST group was higher than that of EST-EPLBD group (2.36%), the difference was statistically significant (P< 0.05). The short-term recurrence rate in the EST group was not significantly higher than that of the EST-EPLBD group (P> 0.05). The long-term recurrence rate for the EST group was significantly higher than that of the EST-EPLBD group (P< 0.05). Cholecystectomy, sex, and age were not associated with the recurrence of ductal stones. The serum level of cholesterol, body-mass index, gallstones, maximum stone diameter, number of stones, and mechanical lithotripsy were risk factors for the recurrence of ductal stones. Minimal size of the duodenal papilla incision was a protective factor with regard to the recurrence of ductal stones.Conclusions:Small-incision EST-EPLBD has a similar overall success rate and a significantly lower rate of the recurrence of ductal stones, bleeding and bile reflux, recurrent pancreatitis, the acute pancreatitis is not higher than that of EST group.Thus, the curative effect of EST-EPLBD is better than that of EST alone. Logistic regression analysis shows that the serum level of cholesterol, body-mass index, gallstones, maximum stone diameter, number of stones, and mechanical lithotripsy were risk factors for the recurrence of ductal stones. Minimal size of the duodenal papilla incision protects against the recurrence of common bile duct stone. Small-incision EST-EPLBD is particularly suitable for young and middle-aged patients. |
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