Cochrane DB Syst. Rev:急性胆囊炎宜早期手术
2013-04-24 佚名 EGMN
印第安纳波利斯——迄今最大规模的关于急性胆囊炎手术时机的研究显示,对于这种常见疾病,早期腹腔镜胆囊切除术的预后优于推迟手术。 长期以来,急性胆囊炎最佳手术干预时机一直存在争议。进行ACDC(急性胆囊炎:早期与推迟胆囊切除术的比较)试验的原因为,在对纳入451例急性胆囊炎患者的5项较小型随机试验的Cochrane回顾中,研究者认为,尚无充分证据支持哪种手术策略是最佳的。 ACDC试验
印第安纳波利斯——迄今最大规模的关于急性胆囊炎手术时机的研究显示,对于这种常见疾病,早期腹腔镜胆囊切除术的预后优于推迟手术。
长期以来,急性胆囊炎最佳手术干预时机一直存在争议。进行ACDC(急性胆囊炎:早期与推迟胆囊切除术的比较)试验的原因为,在对纳入451例急性胆囊炎患者的5项较小型随机试验的Cochrane回顾中,研究者认为,尚无充分证据支持哪种手术策略是最佳的。
ACDC试验中共纳入618例无并发症的急性胆囊炎患者,这些患者接受相同的抗生素(莫西沙星)治疗,患者随机接受早期腹腔镜胆囊切除术(早期胆囊切除术的定义为在就诊后24 h内进行手术)或将手术推迟至第7~45天。研究中排除妊娠患者,在欧洲的35家医院进行,其中包括7家德国的大学医学中心。所有参与研究的医院均配备有进行困难腹腔镜胆囊切除术经验的外科团队。主要终点为75天内的并发症发生率,其中包括胆管炎、胰腺炎、胆漏、卒中、心肌梗死、脓肿、出血、腹膜炎、感染和肾功能衰竭。
德国海德堡大学的Markus W. Buchler医生在美国外科学会(ASA)2013年会上报告的结果显示,早期胆囊切除组的并发症发生率为11.6%,推迟手术组为31.3%。在争议较少的ASA评分≤2分的患者中,发生率分别为9.7%和28.6%。在ASA评分>2分的患者中,早期和推迟腹腔镜胆囊切除组的总并发症发生率分别为20%和47%。早期和推迟腹腔镜胆囊切除术组转为开放手术的发生率水平相似,分别为9.9%和11.9%。早期和推迟手术组的平均住院时间分别为5.4天和10.0天。采用德国DRG系统计算的平均总住院费用分别为2,919和4,261欧元。 研究者另外指出,在德国,即使未发生并发症,患者的住院时间也一般比较长,所以在该研究中,尽管推迟手术组的并发症发生率为早期手术组的3倍,早期手术组和推迟手术组的胆囊切除术后平均住院时间仍非常接近,分别为4.68和4.89天。并且因为仅在有必要时(如黄疸)进行术中胆管造影术,故研究中进行术中胆管造影术的比例不足3%。
与胆囊炎相关的拓展阅读:
Early cholecystectomy beats delayed in acute cholecystitis
INDIANAPOLIS – Acute cholecystitis patients fared significantly better with early rather than delayed laparoscopic cholecystectomy in the largest-ever randomized trial addressing surgical timing for this common condition.
Patients assigned to early cholecystectomy – that is, surgery within 24 hours of presentation to the hospital – had one-third the morbidity, markedly shorter hospital lengths of stay, and correspondingly lower hospital costs compared with patients who underwent surgery on day 7-45, according to Dr. Markus W. Buchler of Heidelberg (Ger.) University.
"Early cholecystectomy in patients fit for surgery and in hospitals experienced in doing difficult laparoscopic cholecystectomies should become the standard of care in acute cholecystitis," he declared in presenting the results of the ACDC (Acute Cholecystitis: Early Versus Delayed Cholecystectomy) trial at the annual meeting of the American Surgical Association.
The optimal timing of surgical intervention in acute cholecystitis is a subject of long-standing controversy. The ACDC trial was conducted because in a Cochrane review of five smaller randomized trials totaling 451 acute cholecystitis patients, researchers concluded there was insufficient evidence to say which surgical strategy was best (Cochrane Database Syst. Rev. 2006 Oct 18;4:CD005440).
Dr. Buchler noted that surveys indicate many American surgeons prefer to delay laparoscopic cholecystectomy, while in Germany the surgical preference is for immediate surgery in patients with uncomplicated acute cholecystitis.
The ACDC trial involved 618 patients with uncomplicated acute cholecystitis who were placed on the same antibiotic – moxifloxacin – and randomized to early laparoscopic cholecystectomy or to delayed surgery on day 7-45. Pregnant patients were excluded from the trial, which was conducted at 35 European hospitals, including seven German university medical centers. All participating hospitals were staffed by surgical teams experienced in performing difficult laparoscopic cholecystectomies.
The primary endpoint was total morbidity within 75 days. This included cholangitis, pancreatitis, biliary leak, stroke, myocardial infarction, abscess, bleeding, peritonitis, infection, and renal failure. The rate was 11.6% in the early cholecystectomy group compared with 31.3% with delayed surgery. Among less challenging patients with an ASA score of 2 or less, the rates were 9.7% and 28.6%, respectively. Patients with an ASA score above 2 had an overall morbidity rate of 20% with early surgery compared with 47% with delayed laparoscopic cholecystectomy.
The rate of conversion to open surgery was 9.9% in the early laparoscopic cholecystectomy group and similar at 11.9% in the delayed surgery group. This came as a surprise to Dr. Buchler and his coinvestigators. They expected a significantly higher conversion rate in conjunction with delayed laparoscopic cholecystectomy.
"I think what this tells us is surgeons have gotten really good at laparoscopic cholecystectomy even in more difficult situations," he observed.
Total hospital stays averaged 5.4 days in the early surgery group compared with 10.0 days with delayed surgery. Mean total hospital costs calculated via the German DRG system were 2,919 euro in the early cholecystectomy group and 4,261 euro with delayed surgery.
Discussant Dr. Andrew L. Warshaw praised Dr. Buchler and his coworkers in the German surgical clinical trials study group for their "leadership in determining evidence-based standards of care."
"There’s no doubt in my mind that immediate cholecystectomy is superior in this patient population," said Dr. Warshaw, professor and chairman of the department of surgery at Harvard Medical School, Boston.
Noting that most acute cholecystitis patients are first seen by an internist or gastroenterologist who then makes the initial treatment decision, Dr. Warshaw asked Dr. Buchler if German internists and gastroenterologists have gotten on board this immediate surgery treatment pathway.
"Convincing internists and gastroenterologists will take a long time, at least in Germany," the surgeon replied. "It is much easier to convince the emergency department physicians to refer patients early to surgery; they’re much closer to the surgeons."
He noted that German surgical practice differs from that in the United States in several respects. For one, German patients routinely stay in the hospital longer, even if they don’t experience complications. That’s why the mean length of stay after cholecystectomy in ACDC was 4.68 days in the early surgery group and closely similar at 4.89 days in the delayed surgery group, even though the delayed surgery group had a threefold higher complication rate.
Another difference is that, unlike in this country, intraoperative cholangiography is rarely done in Germany.
"It’s the absolute exception that intraoperative cholangiography is used. It is used only when there’s a reason for it, such as jaundice. There was probably less than a 3% intraoperative cholangiography rate in this trial," said Dr. Buchler.
The ACDC trial was funded with government research grants. Dr. Buchler reported having no financial conflicts.
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