Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial.
Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial.
复制标题
内窥镜括约肌切开术对可疑的ODDI功能障碍括约肌对胆囊切除术后疼痛相关的残疾的括约肌的影响：EPIPOD随机临床试验。
DOI：
10.1001/jama.2014.5220
复制
发表时间：
2014-05
影响因子：
120.7
通讯作者：
Robuck, Patricia
中科院分区：
文献类型：
--
作者：
Cotton, Peter B.;Durkalski, Valerie;Romagnuolo, Joseph;Pauls, Qi;Fogel, Evan;Tarnasky, Paul;Aliperti, Giuseppe;Freeman, Martin;Kozarek, Richard;Jamidar, Priya;Wilcox, Mel;Serrano, Jose;Brawman-Mintzer, Olga;Elta, Grace;Mauldin, Patrick;Thornhill, Andre;Hawes, Robert;Wood-Williams, April;Orrell, Kyle;Drossman, Douglas;Robuck, Patricia
胆囊切除术后腹痛是常见的，可能是由于奥狄括约肌功能障碍。治疗通常包括内镜逆行胰胆管造影术（ERCP），测压和括约肌切开术。确定内镜下括约肌切开术是否能减轻疼痛以及括约肌测压是否能预测疼痛缓解。一项多中心、假对照、随机试验，纳入214例胆囊切除术后疼痛且影像学或实验室检查无显著异常、既往未接受过括约肌治疗或胰腺炎的患者，随机分配（2008年8月6日至2012年3月23日）在7家转诊医疗中心接受括约肌切开术或假治疗。1年随访为盲法。最后一次随访是2013年3月21日。ERCP后，患者以2：1的比例随机分为括约肌切开术组（n = 141）和假手术组（n = 73），不考虑测压结果。那些随机接受括约肌切开术伴胰腺括约肌压力升高的患者再次随机（1：1）接受胆道或胆道和胰腺括约肌切开术。72例患者进入一项常规ERCP管理的观察性研究。治疗成功定义为随机化后第9个月和第12个月前90天内因疼痛导致的残疾少于6天，未使用麻醉剂，也未进一步进行括约肌干预。假治疗组中有27名患者（37%; 95%CI，25.9%-48.1%）成功治疗，而括约肌切开术组中有32名患者（23%; 95%CI，15.8%-29.6%）成功治疗（校正风险差异，−15.6%; 95%CI，−28.0%至−3.3%; P = 0.01）。在胰腺括约肌高血压患者中，14例（30%; 95% CI，16.7%-42.9%）接受双重括约肌切开术，10例（20%; 95% CI，8.7%-30.5%）仅接受胆道括约肌切开术治疗成功。37名治疗患者（26%; 95%CI，19%-34%）和25名假手术组患者（34%; 95%CI，23%-45%）接受了重复ERCP干预（P = 0.22）。测压结果与结局无关。没有一个临床亚组比其他亚组更能从括约肌切开术中获益。初次括约肌切开术后15例患者（11%）发生胰腺炎，假手术组11例患者（15%）发生胰腺炎。在观察性研究组的非随机化患者中，5例（24%; 95%CI，6%-42%）接受了胆道括约肌切开术，12例（31%; 95%CI，16%-45%）接受了双括约肌切开术，2例（17%; 95%CI，0%-38%）未接受括约肌切开术，治疗成功。在胆囊切除术后腹痛的患者中，行ERCP测压，括约肌切开术与假手术相比，并没有减少疼痛所致的残疾。这些结果不支持ERCP和括约肌切开术治疗这些患者。clinicaltrials.gov标识符：00688662
Abdominal pain after cholecystectomy is common and may be attributed to sphincter of Oddi dysfunction. Management often involves endoscopic retrograde cholangiopancreatography (ERCP) with manometry and sphincterotomy. To determine whether endoscopic sphincterotomy reduces pain and whether sphincter manometric pressure is predictive of pain relief. Multicenter, sham-controlled, randomized trial involving 214 patients with pain after cholecystectomy without significant abnormalities on imaging or laboratory studies, and no prior sphincter treatment or pancreatitis randomly assigned (August 6, 2008-March 23, 2012) to undergo sphincterotomy or sham therapy at 7 referral medical centers. One-year follow-up was blinded. The final follow-up visit was March 21, 2013. After ERCP, patients were randomized 2:1 to sphincterotomy (n = 141) or sham (n = 73) irrespective of manometry findings. Those randomized to sphincterotomy with elevated pancreatic sphincter pressures were randomized again (1:1) to biliary or to both biliary and pancreatic sphincterotomies. Seventy-two were entered into an observational study with conventional ERCP managemeny. Success of treatment was defined as less than 6 days of disability due to pain in the prior 90 days both at months 9 and 12 after randomization, with no narcotic use and no further sphincter intervention. Twenty-seven patients (37%; 95%CI, 25.9%-48.1%) in the sham treatment group vs 32 (23%; 95%CI, 15.8%-29.6%) in the sphincterotomy group experienced successful treatment (adjusted risk difference, −15.6%; 95% CI, −28.0% to −3.3%; P = .01). Of the patients with pancreatic sphincter hypertension, 14 (30%; 95% CI, 16.7%-42.9%) who underwent dual sphincterotomy and 10 (20%; 95% CI, 8.7%-30.5%) who underwent biliary sphincterotomy alone experienced successful treatment. Thirty-seven treated patients (26%; 95% CI,19%-34%) and 25 patients (34%; 95% CI, 23%-45%) in the sham group underwent repeat ERCP interventions (P = .22). Manometry results were not associated with the outcome. No clinical subgroups appeared to benefit from sphincterotomy more than others. Pancreatitis occurred in 15 patients (11%) after primary sphincterotomies and in 11 patients (15%) in the sham group. Of the nonrandomized patients in the observational study group, 5 (24%; 95%CI, 6%-42%) who underwent biliary sphincterotomy, 12 (31%; 95%CI, 16%-45%) who underwent dual sphincterotomy, and 2 (17%; 95%CI, 0%-38%) who did not undergo sphincterotomy had successful treatment. In patients with abdominal pain after cholecystectomy undergoing ERCP with manometry, sphincterotomy vs sham did not reduce disability due to pain. These findings do not support ERCP and sphincterotomy for these patients. clinicaltrials.gov Identifier: 00688662
登录
查看更多内容
影响因子：
4.3
作者：
Durkalski, Valerie;Stewart, Walter;Cotton, Peter
通讯作者：
Cotton, Peter
影响因子：
2.8
作者：
Rana, JS;Mannam, A;Laham, RJ
通讯作者：
Laham, RJ
影响因子：
29.4
作者：
Behar, Jose;Corazziari, Enrico;Toouli, James
通讯作者：
Toouli, James
影响因子：
3.3
作者：
Drossman, DA;Leserman, J;Toomey, TC
通讯作者：
Toomey, TC
影响因子：
1.9
作者：
OBRIEN, PC;FLEMING, TR
通讯作者：
FLEMING, TR