内镜下乳头括约肌小切开联合球囊扩张治疗胆总管结石的随机对照研究
Small endoscopic sphincterotomy combined with endoscopic papillary balloon dilation for common bile duct stones:a randomized controlled study
摘要目的:评价经内镜乳头括约肌小切开术( SEST)联合内镜下球囊扩张术( EPBD)治疗胆总管结石的疗效和安全性,并探讨其对胆道压力的影响。方法152例患者采用电脑随机单双号原则随机分成2组,观察组85例行SEST联合EPBD取石,对照组67例行SEST取石,比较2组一次性取净结石成功率、手术前后胆道压力测量值、并发症总体发生率及随访胆道压力测量值。结果152例均顺利完成内镜治疗和测压操作。一次性结石取净率组间差异无统计学意义[92?94%(79/85)比95?52%(64/67),P=0?746]。2组内镜治疗后Oddi括约肌基础压(SOBP)、胆总管内压( CBDP )较术前均有明显下降( P<0?05),且观察组术后 SOBP 低于对照组[(31?0±11?5) mmHg (1mmHg=0?133 kPa)比(37?6±12?3)mmHg,P>0?05],术后 CBDP 亦低于对照组[(16?3±10?2)mmHg比(19?8±13?1)mmHg,P>0?05]。术后并发症总体发生率观察组与对照组比较,差异无统计学意义[6?33%(5/79)比4?69%(3/64),P=0?953]。143例一次性结石取净的患者随访3~21个月,29例失访,其余114例术后3个月复查了胆道压力,SOBP和CBDP在观察组与对照组间差异均无统计学意义( P>0?05)。结论 SEST联合EPBD治疗胆总管结石安全有效,有利于降低胆道压力,可以保护胆道括约肌功能。
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abstractsObjective To evaluate the efficacy and safety of small endoscopic sphincterotomy com?bined with endoscopic papillary balloon dilation for common bile duct stones, and to investigate their effects on the biliary pressure. Methods A total of 152 patients were randomly divided into experimental group (n=67)who underwent SEST and the control group (n=85)who underwent SEST+EPBD according to odd and even numbers randomly generated by a computer. Success rate of a one?time stone removal, biliary pres?sure measurements before and after surgery, the total incidence of complications and bile duct pressure meas?urements during follow?up were compared between the two groups. Results All 152 cases successfully com?pleted manometry and endoscopic treatment operations. There was no significant difference in the rate of one?time stone removal between the two groups[92?94% (79/85) VS 95?52% (64/67), P=0?746]; SOBP and CBDP after endoscopic treatment compared with those before operation decreased significantly ( P<0?05) . SOBP in the experiment group was lower than that in the control group [ 31?0 ± 11?5 mmHg (1 mmHg=0?133 kPa) VS 37?6 ± 12?3 mmHg, P>0?05] after the treatment, and CBDP was also lower than that in the control group(16?3 ± 10?2 mmHg VS 19?8 ±13?1 mmHg, P>0?05) after the treatment. There was no significant difference in the overall incidence of postoperative complications[6?33% (5/79) VS 4?69% (3/64), P=0?953]. There were 143 cases (9 cases of secondary endoscopic were excluded) which were followed up for 3 to 21 months, 29 cases lost. Postoperative biliary pressure in 114 patients were reviewed, and there was no significant difference in the SOBP(P>0?05)and CBDP between the two groups ( P>0?05) . Conclusion SEST combined with EPBD treatment of common bile duct stones is safe and ef?fective, which helps to reduce biliary pressure and to protect biliary sphincter function.
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