夹心法食管胃十二指肠镜检查对十二指肠大乳头检查的影响：一项非劣效、随机对照试验。

Effect of cap-assisted esophagogastroduodenoscopy on examination of the major duodenal papilla: a noninferior, randomized controlled trial.

机构信息

State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.

Department of Gastroenterology, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.

出版信息

Endoscopy. 2019 May;51(5):427-435. doi: 10.1055/a-0767-6529. Epub 2019 Jan 8.

DOI:10.1055/a-0767-6529

PMID:30620948

Abstract

BACKGROUND

Cap-assisted esophagogastroduodenoscopy (CA-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for examination of the major duodenal papilla (MDP). However, it remains unclear whether CA-EGD is noninferior to standard duodenoscopy for MDP examination. The aim of this study was to compare the efficacies of the two methods for complete examination of the MDP.

METHODS

This prospective, noninferior, randomized controlled study was conducted at two endoscopy centers. Consecutive patients who underwent endoscopic retrograde cholangiopancreatography were randomized (1:1) to undergo CA-EGD or standard duodenoscopy for MDP examination. The primary outcome was complete examination of the MDP, defined as visualization of the upper end, opening, and lower end of the papilla. Secondary outcomes included endoscopic findings and the time taken for the MDP examination.

RESULTS

The study was terminated for futility after the interim analysis. A total of 171 patients were randomly allocated to CA-EGD (n = 85) or standard duodenoscopy (n = 86). The baseline characteristics were comparable between the two groups. Complete examination of the MDP was achieved in 58/85 patients (68.2 %) in the CA-EGD group and in 74/86 (86.0 %) in standard duodenoscopy group. The difference in proportions was - 17.81 percentage points (95 % confidence interval [CI] -28.14 to -7.48) by intention-to-treat analysis and - 18.22 percentage points (95 %CI -28.34 to -8.10) by per-protocol analysis, both of which were significantly lower than the noninferiority margin of -5 %, and therefore the noninferiority of CA-EGD could not be confirmed. Examination time was significantly longer with CA-EGD (69.5 [SD 46.4] vs. 33.0 [SD 28.9] seconds; < 0.001).

CONCLUSIONS

Although complete examination of the MDP can be achieved by CA-EGD in most patients, it could not replace duodenoscopy as the standard method for examination of the MDP.

摘要

背景

带帽食管胃十二指肠镜（CA-EGD）使用安装在镜尖端的透明帽已成为检查主要十二指肠乳头（MDP）的替代方法。然而，CA-EGD 是否不劣于标准十二指肠镜检查 MDP 仍然不清楚。本研究的目的是比较两种方法对 MDP 完全检查的效果。

方法

这是一项在两个内镜中心进行的前瞻性、非劣效性、随机对照研究。连续接受内镜逆行胰胆管造影术的患者被随机（1:1）分为 CA-EGD 或标准十二指肠镜检查 MDP。主要结局是 MDP 的完全检查，定义为乳头的上、开口和下末端的可视化。次要结局包括内镜发现和 MDP 检查所需的时间。

结果

在中期分析后，由于无效而终止了这项研究。共 171 例患者被随机分配至 CA-EGD（n = 85）或标准十二指肠镜（n = 86）组。两组的基线特征无差异。在 CA-EGD 组中，58/85 例（68.2 %）患者和标准十二指肠镜组中 74/86 例（86.0 %）患者完成了 MDP 的完全检查。意向治疗分析的比例差异为-17.81 个百分点（95%置信区间 [CI] -28.14 至 -7.48），按方案分析为-18.22 个百分点（95%CI -28.34 至 -8.10），均显著低于非劣效性边界 -5%，因此不能确认 CA-EGD 的非劣效性。CA-EGD 的检查时间明显长于标准十二指肠镜（69.5 [SD 46.4] 与 33.0 [SD 28.9] 秒；<0.001）。