Severe and fatal complications after diagnostic and therapeutic ERCP: a prospective series of claims to insurance covering public hospitals.
Severe and fatal complications after diagnostic and therapeutic ERCP: a prospective series of claims to insurance covering public hospitals.
复制标题
诊断和治疗性 ERCP 后的严重和致命并发症：对公立医院保险的一系列前瞻性索赔。
作者：
R. Trap;S. Adamsen;O. Hart;M. Henriksen
背景和研究目的
越来越多的患者在腹腔镜胆囊切除术之前接受内镜逆行胰胆管造影 (ERCP)，并且越来越多的科室和医生正在实施 ERCP，而来自大型前瞻性系列的新数据已经记录了诊断性和治疗性 ERCP 的风险。丹麦成立了患者保险协会，自 1992 年 7 月起承保公立医院检查和治疗期间造成的伤害，这使得收集和分析大量已索赔的 ERCP 并发症的前瞻性系列成为可能。
患者和方法
对1992年7月1日至1996年12月31日期间发生的ERCP术后并发症连续提出的39起赔偿索赔进行了调查。审查了病例记录以及实验室报告和射线照片。根据国际共识对并发症进行分类。
结果
25 家医院共 39 起索赔案件。 31 例患者适合进行 ERCP。7 例患者进行了预切乳头切开术。并发症的严重程度为 1 名患者为轻度，3 名患者为中度，24 名患者为重度，9 名患者致命；在两起案件中，严重程度无法分类。并发症为：胰腺炎23例（7例死亡，其中1例涉及预切手术），出血2例，穿孔9例（6例预切手术，1例死亡），其他原因5例（其中1例死亡）。 9例死亡病例中，2例未能插管，4例内镜逆行胆管造影正常，其中1例接受了括约肌切开术。一名既往患有腺瘤的患者取出了内置假体，随后出现坏疽性胆囊炎并死亡。三十名患者有资格获得赔偿。被拒绝的病例包括轻度和中度胰腺炎、1例患者拒绝输血的致命性出血性胰腺炎病例以及1例在ERCP之前患有胰腺炎的患者。
结论
ERCP，即使用于诊断目的，也可能与非常严重甚至致命的并发症有关。使用预切程序进行访问仍然应该被认为是危险的。应开发其他检查胆管的方法。如果内镜超声检查和磁共振胆管造影被证明具有与 ERCP 相同的诊断价值（ERCP 必须被视为当今胆管可视化的金标准），那么它们可能会取代 ERCP 作为中度或低度胆管结石风险患者的主要检查；这将减少暴露于 ERCP 风险的患者数量。
BACKGROUND AND STUDY AIMS
Increasing numbers of patients are undergoing endoscopic retrograde cholangiopancreatography (ERCP) prior to laparoscopic cholecystectomy, and more departments and doctors are performing ERCP, while new data from large prospective series have documented the risks of both diagnostic and therapeutic ERCP. The establishment in Denmark of a Patient Insurance Association, which has covered injury caused during investigation and treatment in public hospitals since July 1992, has made it possible to collect and analyze a large prospective series of ERCP complications for which compensation has been claimed.
PATIENTS AND METHODS
Thirty-nine consecutive claims for compensation due to complications after ERCP occurring between 1 July 1992 and 31 December 1996 were investigated. Case notes were reviewed, along with laboratory reports and radiographs. The complications were classified according to the international consensus.
RESULTS
Claims for compensation were made in 39 cases from 25 hospitals. The indication for ERCP was appropriate in 31. Precut papillotomy for access had been performed in seven. The severity of the complications was mild in one patient, moderate in three patients, severe in 24, and fatal in nine; in two cases, the severity was not classifiable. The complications were: pancreatitis in 23 patients (seven cases fatal, one of which had involved a precut procedure), bleeding in two, perforation in nine (six had a precut procedure, one died), and other reasons in five (including one fatal case). Among the nine fatal cases, cannulation had not been achieved in two and the endoscopic retrograde cholangiogram was normal in four, one of whom underwent a sphincterotomy. One patient with a previous adenoma had an endoprosthesis removed, developed gangrenous cholecystitis afterward, and died. Thirty patients were eligible for compensation. The rejected cases included mild and moderate pancreatitis, a case of fatal hemorrhagic pancreatitis in which the patient had refused blood transfusion, and one patient who had pancreatitis prior to ERCP.
CONCLUSIONS
ERCP, even for diagnostic purposes, may be associated with very serious and even fatal complications. The use of the precut procedure for access should still be considered dangerous. Other means of investigating the bile ducts should be developed. If endoscopic ultrasonography and magnetic resonance cholangiography prove to have the same diagnostic value as ERCP, which must be considered the gold standard for visualizing the ducts today, they might replace ERCP as the primary investigation in patients with an intermediate or low risk of bile duct stones; this would reduce the numbers of patients exposed to the risks of ERCP.