Center for Interventional Endoscopy, Florida Hospital, Orlando, Florida.
Center for Specialized Surgery, Florida Hospital, Orlando, Florida.
Gastroenterology. 2019 Mar;156(4):1027-1040.e3. doi: 10.1053/j.gastro.2018.11.031. Epub 2018 Nov 16.
BACKGROUND & AIMS: Infected necrotizing pancreatitis is a highly morbid disease with poor outcomes. Intervention strategies have progressed from open necrosectomy to minimally invasive approaches. We compared outcomes of minimally invasive surgery vs endoscopic approaches for patients with infected necrotizing pancreatitis.
We performed a single-center, randomized trial of 66 patients with confirmed or suspected infected necrotizing pancreatitis who required intervention from May 12, 2014, through March 24, 2017. Patients were randomly assigned to groups that received minimally invasive surgery (laparoscopic or video-assisted retroperitoneal debridement, depending on location of collection, n = 32) or an endoscopic step-up approach (transluminal drainage with or without necrosectomy, n = 34). The primary endpoint was a composite of major complications (new-onset multiple organ failure, new-onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, bleeding and perforation of a visceral organ) or death during 6 months of follow-up.
The primary endpoint occurred in 11.8% of patients who received the endoscopic procedure and 40.6% of patients who received the minimally invasive surgery (risk ratio 0.29; 95% confidence interval 0.11-0.80; P = .007). Although there was no significant difference in mortality (endoscopy 8.8% vs surgery 6.3%; P = .999), none of the patients assigned to the endoscopic approach developed enteral or pancreatic-cutaneous fistulae compared with 28.1% of the patients who underwent surgery (P = .001). The mean number of major complications per patient was significantly higher in the surgery group (0.69 ± 1.03) compared with the endoscopy group (0.15 ± 0.44) (P = .007). The physical health scores for quality of life at 3 months was better with the endoscopic approach (P = .039) and mean total cost was lower ($75,830) compared with $117,492 for surgery (P = .039).
In a randomized trial of 66 patients, an endoscopic transluminal approach for infected necrotizing pancreatitis, compared with minimally invasive surgery, significantly reduced major complications, lowered costs, and increased quality of life. Clinicaltrials.gov no: NCT02084537.
感染性坏死性胰腺炎是一种高度致命的疾病，预后不良。干预策略已经从开放性坏死性胰腺炎切除术发展为微创方法。我们比较了微创外科与内镜方法治疗感染性坏死性胰腺炎患者的疗效。
我们对 2014 年 5 月 12 日至 2017 年 3 月 24 日期间需要介入治疗的 66 例确诊或疑似感染性坏死性胰腺炎患者进行了单中心、随机试验。患者被随机分配到接受微创外科（腹腔镜或视频辅助腹膜后清创术，取决于收集物的位置，n=32）或内镜逐步治疗（经内镜引流伴或不伴坏死组织切除术，n=34）的两组。主要终点是 6 个月随访期间主要并发症（新发多器官衰竭、新发全身功能障碍、肠内或胰皮瘘、内脏器官出血和穿孔）或死亡的复合事件。
内镜组的主要终点发生率为 11.8%，微创外科组为 40.6%（风险比 0.29；95%置信区间 0.11-0.80；P=0.007）。尽管内镜组和外科组的死亡率无显著差异（内镜组 8.8%，外科组 6.3%；P=0.999），但与接受外科手术的患者（28.1%）相比，接受内镜治疗的患者无一例发生肠内或胰皮瘘（P=0.001）。外科组患者的平均主要并发症发生率（0.69±1.03）明显高于内镜组（0.15±0.44）（P=0.007）。内镜组患者的健康评分在 3 个月时更高（P=0.039），且总费用更低（$75830 美元），而外科组费用为$117492 美元（P=0.039）。
在一项 66 例患者的随机试验中，与微创外科相比，内镜经腔途径治疗感染性坏死性胰腺炎可显著降低主要并发症发生率，降低成本，并提高生活质量。Clinicaltrials.gov 编号：NCT02084537。
