现在的位置: 首页时讯速递, 进展交流>正文
[Lancet最新论文]:感染性坏死性胰腺炎的内镜下升级治疗与手术升级治疗
2018年01月16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 2018; 391: 51-58

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是致死性疾病,有指证采取有创干预治疗。手术升级治疗是标准治疗方法,而内镜下升级治疗则是一种有前景的替代治疗手段。我们对两种方法进行了比较,试图证明在临床及经济学预后方面,内镜下升级治疗方法是否优于手术升级治疗方法

Methods 方法

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.

这是荷兰19家医院参加的一项多中心随机优效研究,入选标准为感染性坏死性胰腺炎的成年患者,且有指证进行有创治疗措施。患者被随机分为内镜下或手术升级治疗组。内镜下治疗组包括内镜下超声引导经腔引流,必要时进行内镜下坏死组织清除。手术治疗包括经皮置管引流,必要时进行腔镜下腹膜后清创术。主要预后指标为包括6个月随访期间主要并发症或死亡的综合预后指标。采用意向治疗分析。研究在 ISRCTN 注册,注册号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,我们筛选了418名胰腺或胰腺外坏死的患者,最终98名患者入选并随机分为内镜下升级治疗组(n=51)或手术升级治疗组(n=47)。内镜治疗组51名患者中22名(43%),以及手术治疗组47名患者中21名(45%)发生主要预后终点(风险比[RR] 0·97, 95% CI 0·62–1·51; p=0·88)。两组患者间病死率无显著差异(内镜治疗组9名 [18%] vs. 手术治疗组6名 [13%] 患者死亡;RR 1·38, 95% CI 0·53–3·59, p=0·50),且主要预后指标中包含的主要并发症也无显著差异。

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,在减少主要并发症或死亡方面,内镜下升级治疗并不优于手术升级治疗。内镜治疗组胰瘘发生率较低,住院日较短。本试验结果可能导致内镜下升级治疗成为治疗首选。

Funding

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

给我留言

您必须 [ 登录 ] 才能发表留言!

×
腾讯微博