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帽辅助上消化道内镜检查十二指肠大乳头:一项随机、双盲、对照交叉研究(CAPPA研究)

Cap Assisted Upper Endoscopy for Examination of the Major Duodenal Papilla: A Randomized, Blinded, Controlled Crossover Study (CAPPA Study).

作者信息

Abdelhafez Mohamed, Phillip Veit, Hapfelmeier Alexander, Elnegouly Mayada, Poszler Alexander, Strobel Kilian, Born Peter, Dollhopf Markus, Kassem Abdel Meguid, Calavrezos Lenika, Klare Peter, Schlag Christoph, Bajbouj Monther, Schmid Roland M, von Delius Stefan

机构信息

II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität Mìnchen, Munich, Germany.

Institut fìr Medizinische Statistik und Epidemiologie, Klinikum rechts der Isar der Technischen Universität Mìnchen, Munich, Germany.

出版信息

Am J Gastroenterol. 2017 May;112(5):725-733. doi: 10.1038/ajg.2017.47. Epub 2017 Mar 14.

DOI:10.1038/ajg.2017.47
PMID:28291239
Abstract

OBJECTIVE

Examination of major duodenal papilla (MDP) by standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Cap assisted esophagogastroduodenoscopy (CA-EGD) utilizes a cap fitted to the tip of the endoscope that can depress the mucosal folds and thus might improve visualization of MDP. The aim of this study was to compare CA-EGD to S-EGD for complete examination of the MDP.

METHODS

Prospective, randomized, blinded, controlled crossover study. Subjects scheduled for elective EGD were randomized to undergo S-EGD (group A) or CA-EGD (group B) before undergoing a second examination by the alternate method. Images of the MDP were evaluated by three blinded multicenter-experts. Our primary outcome measure was complete examination of the papilla. Secondary outcome measures were duration and overall diagnostic yield.

RESULTS

A total of 101 patients were randomized and completed the study. Complete examination of MDP was achieved in 98 patients using CA-EGD compared to 24 patients using S-EGD (97 vs. 24%, P<0.001). Median duration from intubation of the esophagus until localization of the MDP was shorter with CA-EGD (46. vs. 96 s., P<0.001). In group A, 11 extra lesions and 12 additional incidental findings were detected by secondary CA-EGD, whereas neither were detected by secondary S-EGD in group B (22 vs. 0% and 24 vs. 0%, P<0.001 and P<0.001).

CONCLUSION

CA-EGD enabled complete examination of MDP in almost all cases compared to a low success rate of S-EGD. CA-EGD detected a significant amount of lesions and incidental findings when added to S-EGD. CA-EGD is a safe and effective method for examination of MDP.

摘要

目的

通过标准前视食管胃十二指肠镜检查(S-EGD)对十二指肠乳头(MDP)的检查存在局限性。帽辅助食管胃十二指肠镜检查(CA-EGD)使用安装在内窥镜尖端的帽,该帽可压平黏膜皱襞,从而可能改善MDP的可视化。本研究的目的是比较CA-EGD和S-EGD对MDP的完整检查情况。

方法

前瞻性、随机、双盲、对照交叉研究。计划进行择期EGD的受试者被随机分为先接受S-EGD(A组)或CA-EGD(B组),然后再用另一种方法进行第二次检查。MDP的图像由三位双盲多中心专家进行评估。我们的主要结局指标是乳头的完整检查。次要结局指标是检查持续时间和总体诊断率。

结果

共有101名患者被随机分组并完成研究。使用CA-EGD的98名患者实现了MDP的完整检查,而使用S-EGD的患者为24名(97%对24%,P<0.001)。从食管插管到定位MDP的中位持续时间,CA-EGD更短(46秒对96秒,P<)。在A组中,二次CA-EGD检测到11个额外病变和另外12个偶然发现,而B组二次S-EGD均未检测到(22%对0%和24%对0%,P<0.001和P<0.001)。

结论

与S-EGD的低成功率相比,CA-EGD在几乎所有病例中都能实现MDP的完整检查。当在S-EGD基础上增加CA-EGD时,能检测到大量病变和偶然发现。CA-EGD是一种安全有效的MDP检查方法。

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