Freeman M L, Nelson D B, Sherman S, Haber G B, Herman M E, Dorsher P J, Moore J P, Fennerty M B, Ryan M E, Shaw M J, Lande J D, Pheley A M
Hennepin County Medical Center, Minneapolis, MN 55415, USA.
N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
Endoscopic sphincterotomy is commonly used to remove bile-duct stones and to treat other problems. We prospectively investigated risk factors for complications of this procedure and their outcomes.
We studied complications that occurred within 30 days of endoscopic biliary sphincterotomy in consecutive patients treated at 17 institutions in the United States and Canada from 1992 through 1994.
Of 2347 patients, 229 (9.8 percent) had a complication, including pancreatitis in 127 (5.4 percent) and hemorrhage in 48 (2.0 Percent). There were 55 deaths from all causes within 30 days; death was directly or indirectly related to the procedure in 10 cases. Of five significant risk factors for complications identified in a multivariate analysis, two were characteristics of the patients (suspected dysfunction of the sphincter of Oddi as an indication for the procedure and the presence of cirrhosis) and three were related to the endoscopic technique (difficulty in cannulating the bile duct achievement of access to the bile duct by "precut" sphincterotomy, and use of a combined percutaneous-endoscopic procedure). The overall risk of complications was not related to the patient's age, the number of coexisting illnesses, or the diameter of the bile duct. The rate of complications was highest when the indication for the procedure was suspected dysfunction of the sphincter of Oddi (21.7 percent) and lowest when the indication was removal of bile-duct stones within 30 days of laparoscopic cholecystectomy (4.9 percent). As compared with those who performed fewer procedures, endoscopists who performed more than one sphincterotomy per week had lower rates of all complications (8.4 percent vs. 11.1 percent, P=0.03) and severe complications (0.9 percent vs. 2.3 percent, P=0.01).
The rate of complications after endoscopic biliary sphincterotomy can vary widely in different circumstances and is primarily related to the indication for the procedure and to endoscopic technique, rather than to the age or general medical condition of the patients.
内镜括约肌切开术常用于去除胆管结石及治疗其他问题。我们对该手术并发症的危险因素及其后果进行了前瞻性研究。
我们研究了1992年至1994年在美国和加拿大17家机构接受连续治疗的患者在内镜胆管括约肌切开术后30天内发生的并发症。
在2347例患者中,229例(9.8%)出现并发症,其中胰腺炎127例(5.4%),出血48例(2.0%)。30天内共有55例各种原因导致的死亡;10例死亡直接或间接与手术相关。在多变量分析确定的五个并发症显著危险因素中,两个是患者特征(怀疑Oddi括约肌功能障碍作为手术指征以及肝硬化的存在),三个与内镜技术有关(胆管插管困难、通过“预切开”括约肌切开术进入胆管以及使用经皮-内镜联合手术)。并发症的总体风险与患者年龄、并存疾病数量或胆管直径无关。当手术指征为怀疑Oddi括约肌功能障碍时,并发症发生率最高(21.7%),而当指征为腹腔镜胆囊切除术后30天内去除胆管结石时,并发症发生率最低(4.9%)。与手术操作较少的内镜医师相比,每周进行一次以上括约肌切开术的内镜医师所有并发症发生率较低(8.4%对11.1%,P = 0.03),严重并发症发生率也较低(0.9%对2.3%,P = 0.01)。
内镜胆管括约肌切开术后并发症发生率在不同情况下差异很大,主要与手术指征和内镜技术有关,而非患者年龄或一般健康状况。