Gorelick A, Barnett J, Chey W, Anderson M, Elta G
Connecticut Gastroenterology Consultants, PC, New Haven, Connecticut, USA.
Endoscopy. 2004 Feb;36(2):170-3. doi: 10.1055/s-2004-814185.
Endoscopic biliary sphincterotomy in patients with sphincter of Oddi dysfunction (SOD) is associated with a high risk of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP), which may be secondary to residual pancreatic sphincter hypertension. It was hypothesized that botulinum toxin injection could be used to reduce pancreatic sphincter hypertension temporarily in SOD patients after biliary sphincterotomy, thereby reducing the rate of procedure-induced pancreatitis.
All patients undergoing ERCP with manometry due to a suspected biliary SOD were asked to participate in the study. Patients with elevated basal sphincter pressures were randomly assigned to receive either botulinum toxin or a sham saline injection after biliary sphincterotomy. Fifty units of botulinum toxin were delivered via a sclerotherapy needle in the form of two 25-U injections of 0.25 ml each into the pancreatic sphincter. In patients in the sham arm, 0.50 ml of saline was injected into the duodenal lumen.
Between 12 February 1999 and 29 November 2000, a total of 98 patients were referred for ERCP with manometry; 86 consented to participate in the study, and 26 had elevated baseline pressures and underwent random assignment. Twelve received botulinum toxin injection and 14 were randomly assigned to receive the sham injection. A total of six patients in the sham group (43 %) developed procedure-induced pancreatitis, compared with three patients in the botulinum toxin group (25 %; P = 0.34).
Biliary sphincterotomy in patients with sphincter of Oddi dysfunction without pancreatic protection is risky and should no longer be carried out. This study demonstrates that botulinum toxin injection into the residual pancreatic sphincter after biliary sphincterotomy is technically feasible and safe, showing a trend toward a reduced post-ERCP pancreatitis rate in patients with sphincter of Oddi dysfunction. Further studies will need to confirm the validity of these experimental results before this technique can be used routinely.
在患有Oddi括约肌功能障碍（SOD）的患者中，内镜逆行胰胆管造影术（ERCP）后行内镜下胆管括约肌切开术与胰腺炎的高风险相关，这可能继发于残余的胰括约肌高压。据推测，肉毒杆菌毒素注射可用于在胆管括约肌切开术后暂时降低SOD患者的胰括约肌高压，从而降低手术诱发胰腺炎的发生率。
所有因疑似胆源性SOD而接受ERCP测压的患者均被邀请参加该研究。基础括约肌压力升高的患者在胆管括约肌切开术后被随机分配接受肉毒杆菌毒素或假盐水注射。50单位的肉毒杆菌毒素通过硬化治疗针以两次每次0.25 ml、各25 U的注射形式注入胰括约肌。在假注射组的患者中，向十二指肠腔内注入0.50 ml盐水。
在1999年2月12日至2000年11月29日期间，共有98例患者被转诊接受ERCP测压；86例同意参加研究，26例基线压力升高并接受随机分配。12例接受肉毒杆菌毒素注射，14例被随机分配接受假注射。假注射组共有6例患者（43%）发生手术诱发的胰腺炎，而肉毒杆菌毒素组有3例患者（25%；P = 0.34）。
在没有胰腺保护的情况下，对Oddi括约肌功能障碍患者进行胆管括约肌切开术有风险，不应再进行。本研究表明，胆管括约肌切开术后向残余胰括约肌注射肉毒杆菌毒素在技术上是可行且安全的，显示出Oddi括约肌功能障碍患者ERCP术后胰腺炎发生率有降低的趋势。在该技术能够常规使用之前，还需要进一步研究来证实这些实验结果的有效性。
