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[Lancet在线发表]:内镜下逐步升级治疗感染性坏死性胰腺炎
2017年11月13日 时讯速递, 进展交流 暂无评论

Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial

Sandra van Brunschot, Janneke van Grinsven, Hjalmar C van Santvoort, et al.

Lancet 2017 epub ahead of print

DOI: http://dx.doi.org/10.1016/S0140-6736(17)32404-2

Summary

Background 背景

Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes.

感染性坏死性胰腺炎可能致死,有指证进行有创干预治疗。逐步升级的外科手术方式是此时的标准治疗方法。另一种治疗手段是逐步升级的内镜下治疗。我们对这两种方式进行了比较,以明确采用逐步升级的内镜下治疗,其临床及经济学预后方面是否优于逐步升级的外科治疗方式。

Methods 方法学

In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composite of major complications or death during 6-month follow-up. Analyses were by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN09186711.

在这项多中心、随机、优效试验中,我们在荷兰19家医院入选了感染性坏死性胰腺炎且有指证进行有创治疗的成年患者。患者被随机分为内镜或手术逐步升级组。内镜下治疗包括内镜超声引导的经腔引流,必要时进行内镜下坏死组织清除术。手术治疗包括经皮置管引流,必要时进行腹腔镜腹膜后清创手术。主要预后终点为复合终点(6个月随访期间主要并发症或死亡)。采用意向治疗分析。试验在ISRCTN注册,注册号为ISRCTN09186711。

Findings 结果

Between Sept 20, 2011, and Jan 29, 2015, we screened 418 patients with pancreatic or extrapancreatic necrosis, of which 98 patients were enrolled and randomly assigned to the endoscopic step-up approach (n=51) or the surgical step-up approach (n=47). The primary endpoint occurred in 22 (43%) of 51 patients in the endoscopy group and in 21 (45%) of 47 patients in the surgery group (risk ratio [RR] 0·97, 95% CI 0·62–1·51; p=0·88). Mortality did not differ between groups (nine [18%] patients in the endoscopy group vs six [13%] patients in the surgery group; RR 1·38, 95% CI 0·53–3·59, p=0·50), nor did any of the major complications included in the primary endpoint.

2011年9月20日至2015年1月29日期间,我们筛查了418名胰腺或胰腺外坏死患者,入选98名患者并随机分为内镜下逐步升级治疗(n = 51)或手术逐步升级治疗(n = 47)。内镜治疗组51名患者中22名(43%)发生主要预后终点事件,手术治疗组47名患者中21名(45%)发生主要预后终点事件(风险比 [RR] 0·97, 95% CI 0·62–1·51; p=0·88)。两组患者病死率无显著差异(内镜组9例 [18%] 患者,手术组6例患者 [13%] ;RR 1·38, 95% CI 0·53–3·59, p=0·50),主要预后终点中包括的任何主要并发症两组间也无差异。

Interpretation 结论

In patients with infected necrotising pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference.

对于感染性坏死性胰腺炎患者,内镜下逐步升级治疗方式在减少主要并发症或死亡方面,并不优于手术逐步升级治疗方式。内镜治疗组患者胰瘘比例较低,住院日较短。这一试验的结果可能导致内镜下逐步升级治疗方式成为治疗首选。

Funding

The Dutch Digestive Disease Foundation, Fonds NutsOhra, and the Netherlands Organization for Health Research and Development.

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