| Objective:To investigate the effect of the duration of endoscopic biliary balloon dilation after small sphincterotomy on the clearance rates of stones and record the change of liver function,the postoperative complications of ERCP to determine the optimal duration of the dilation.Methods:According to the requirements of the prospective randomized controlled clinical trials, selected 160 patients from March 2015 to February 2016 in Nankai Hospital, and all the patients with the extrahepatic bile duct stone treated by the ERCP. Inclusion criteria:age≥18 years, feasible to perform ERCP for the patients with extrahepatic bile duct stones diagnosed by MRCP, abdominal CT,abdominal ultrasonography or EUS(the diameter of stones ≤1.5cm,the diameter of bile duct ≤2.0cm),patients after cholecystectomy or will be performed cholecystectomy. Exclusion criteria: past EST or EPBD, abnormal blood coagulation(INR>1.3), or PLT<50×109/L, combined with acute pancreatitis, biliary tract bleeding, severe liver disease, primary sclerosing cholangitis, Mirizzi syndrome, intrahepatic bile duct stones, hepatobiliary and pancreatic malignant tumors, bile duct segment stenosis(pancreas), fistula of bile duct and duodenum, other contraindications of ERCP. Preoperative programs give ban eating and water six-eight hours, give muscle injection of diazepam 10 mg, pethidine hydrochloride 50 mg, to calm the patients, give phloroglucin injection 10 mg to relaxe the duodenal smooth muscle. Programs of inner operation give left-lateral position,taking belt and ECG monitor.Into the descendant duodenum, we firstly observe the descendant duodenum, and use selective intubation, and then determine the number, size, and location of the stone when contrast medium shows the stones. Here, we can execute the endoscopic biliary balloon dilation after small sphincterotomy with randomized table which used to determine the dilation time(0 second, 30 seconds, 1 minute, 3 minutes,5 minutes), when the balloon waist disappears, then we can try to get the stones out from extrahepatic bile duct. Postoperative programs give ban eating and water twenty-four hours,monitor the respiration, pulse, blood pressure, oxygen saturation and other vital signs,measure 12 h, 24 h and 48 h of blood, pancreatic function and 48 h of liver function, observe 12 h, 24 h, 48 h of temperature, abdominal signs, abdominal pain, abdominal distension, haematemesis, melena, nausea, vomiting and other symptoms.Results:The disposable clearance rates of stones, the rates of mechanical lithotripsy and the average X-ray exposure time were no significant statistical differences. There were significant statistical differences between preoperative liver functions and postoperative liver functions(P<0.05),but the differences of perioperative liver functions were no significant statistical differences(P>0.05). For the post-ERCP pancreatitis, the rates of five groups had no significant statistical difference(P>0.05), by multivariate logistic regression analysis, the pancreatic duct intubation or radiography, the balloon dilatation duration less than or equal to 1 min and mechanical lithotripsy were the independent risk factors of post-ERCP pancreatitis. For the hemorrhage, the rates of five groups had no significant statistical difference(P>0.05), univariate analysis showed that the duration of balloon dilatation larger than 1min was the risk factor for gastrointestinal bleeding aboat ERCP. For the infection, the rates of five groups had no significant statistical differences(P>0.05).Conclusions:The method of endoscopic biliary balloon dilation after small sphincterotomy to treat extrahepatic bile duct stone is safe and effective, which can improve the liver functions effectively. For the analysis of postoperative complications, it is suggested that proper extension of balloon dilation duration is beneficial to ERCP, so, the optimal duration of the dilation may be 3-mins which proposed in this study. |
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