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内镜经壁置管引流与腹腔镜经壁置管内引流治疗急性胰腺炎包裹性坏死的随机对照试验:坏死量的个体化处理。

Endoscopic transmural drainage tailored to quantity of necrotic debris versus laparoscopic transmural internal drainage for walled-off necrosis in acute pancreatitis: A randomized controlled trial.

机构信息

Departments of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.

Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Pancreatology. 2021 Oct;21(7):1291-1298. doi: 10.1016/j.pan.2021.06.006. Epub 2021 Jun 21.

Abstract

BACKGROUND AND AIMS

Both endoscopic and laparoscopic transmural internal drainage are practiced for drainage of walled-off necrosis (WON) following acute pancreatitis (AP) but the superiority of either is not established. Our aim was to compare transperitoneal laparoscopic drainage with endoscopic drainage using either lumen apposing metal stents (LAMS) or plastic stents tailored to the amount of necrotic debris in WON.

METHODS

In a randomized controlled trial, adequately powered to exclude the null hypothesis, patients with symptomatic WON were randomized to either endoscopic or laparoscopic drainage. In the endoscopy group, two plastic stents were placed if the WON contained <1/3rd necrotic debris and a LAMS was placed if it was >1/3rd. Primary outcome was resolution of WON within 4 weeks without re-intervention for secondary infection. Secondary outcome was overall success (resolution of WON at 6 months) and adverse events.

RESULTS

Forty patients were randomized: 20 to each group. Baseline characteristics were comparable between the groups. Primary outcome was similar between the groups [16 (80%) in laparoscopy and 15 (75%) in endoscopy group; p = 0.89]. The overall success was similar [18 (90%) in laparoscopy vs. 17 (85%) in endoscopy; p = 0.9]. Median duration of hospital stay was shorter in endoscopy group [4 (4-8) vs. 6 days (5-9); p = 0.03]. Adverse events were comparable between the groups.

CONCLUSION

Laparoscopic drainage was not superior to endoscopic transmural drainage with placement of multiple plastic stent or LAMS depending on the amount of necrotic debris for symptomatic WON in AP. The hospital stay was shorter with the endoscopic approach.

摘要

背景与目的

内镜和腹腔镜经壁内引流术均用于治疗急性胰腺炎(AP)后包裹性坏死(WON)的引流,但哪种方法更优越尚未确定。我们的目的是比较经皮腹腔镜引流与内镜引流,内镜引流采用的引流方式为根据 WON 中坏死碎片的量放置管腔贴合金属支架(LAMS)或塑料支架。

方法

在一项随机对照试验中,我们进行了充分的功率计算以排除无效假设,将有症状的 WON 患者随机分为内镜或腹腔镜引流组。在内镜组中,如果 WON 中含有 <1/3 坏死碎片,则放置两个塑料支架,如果含有 >1/3 坏死碎片,则放置 LAMS。主要结局是在 4 周内无需再次介入治疗继发性感染而使 WON 得到缓解。次要结局是总体成功率(6 个月时 WON 缓解)和不良事件。

结果

40 例患者被随机分为两组:每组 20 例。两组患者的基线特征无差异。主要结局在两组之间相似[腹腔镜组 16 例(80%),内镜组 15 例(75%);p=0.89]。总体成功率相似[腹腔镜组 18 例(90%),内镜组 17 例(85%);p=0.9]。内镜组的住院时间中位数更短[4(4-8)天 vs. 6 天(5-9);p=0.03]。两组的不良事件相似。

结论

对于 AP 有症状的 WON,根据坏死碎片的量放置多个塑料支架或 LAMS 进行内镜经壁内引流与腹腔镜引流相比不具有优势。内镜治疗的住院时间更短。

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