单气囊与双气囊内镜用于全小肠镜检查的随机对照试验。

Single-balloon versus double-balloon endoscopy for achieving total enteroscopy: a randomized, controlled trial.

机构信息

Department of Gastroenterology and Endoscopy and Endoscopic Surgery, University of Tokyo, Tokyo, Japan.

出版信息

Gastrointest Endosc. 2011 Apr;73(4):734-9. doi: 10.1016/j.gie.2010.10.047. Epub 2011 Jan 26.

DOI:10.1016/j.gie.2010.10.047

PMID:21272875

Abstract

BACKGROUND

Balloon endoscopy has been accepted as an effective tool for examining the small intestine. Two types of balloon endoscopy, single and double, are commercially available. The difference in performance between these 2 types of balloon endoscopy has not yet been elucidated.

OBJECTIVE

To compare the yield of single-balloon endoscopy (SBE) and double-balloon endoscopy (DBE).

DESIGN

Single-center, randomized, controlled trial.

SETTING

University hospital in Tokyo, Japan.

PATIENTS

Patients with suspected small-bowel disease.

INTERVENTIONS

SBE and DBE.

MAIN OUTCOME MEASUREMENTS

Outcomes were the total enteroscopy rate, diagnostic yield, complication rate, and clinical outcomes. Analysis was done by intent to treat.

RESULTS

The study started in April 2008 and was terminated in April 2010 because of an obvious disadvantage for the SBE group. Thirty-eight patients were enrolled in the study; 18 patients were assigned to the SBE group and 20 to the DBE group. The total enteroscopy rate was 0% in the SBE group and 57.1% in the DBE group (P = .002). In terms of complications, the DBE group had 1 patient with Mallory-Weiss syndrome, and the SBE group had 1 patient with hyperamylasemia. There was no difference in the overall diagnosis rate between the SBE and DBE groups (61.1% vs 50.0%, P = .49). There was no difference in therapeutic outcome between the SBE and DBE groups (27.8% vs 35.0%, P = .63).

LIMITATIONS

Relatively small number of study patients.

CONCLUSIONS

Total enteroscopy is more easily performed with DBE than with SBE.

摘要

背景

气囊式小肠镜已被认为是一种有效的小肠检查工具。目前有单气囊和双气囊两种气囊式小肠镜可供商业使用。这两种气囊式小肠镜的性能差异尚未阐明。

目的

比较单气囊小肠镜（SBE）和双气囊小肠镜（DBE）的检查效果。

设计

单中心、随机、对照临床试验。

地点

日本东京的一所大学医院。

患者

疑似小肠疾病患者。

干预措施

SBE 和 DBE。

主要观察指标

总小肠镜检查率、诊断率、并发症发生率和临床转归。采用意向治疗分析。

结果

该研究于 2008 年 4 月启动，2010 年 4 月因 SBE 组明显处于劣势而终止。共纳入 38 例患者，18 例患者被分配至 SBE 组，20 例患者被分配至 DBE 组。SBE 组的总小肠镜检查率为 0%，DBE 组为 57.1%（P =.002）。在并发症方面，DBE 组有 1 例 Mallory-Weiss 综合征患者，SBE 组有 1 例高淀粉酶血症患者。两组的总体诊断率无差异（61.1%比 50.0%，P =.49）。SBE 组和 DBE 组的治疗效果也无差异（27.8%比 35.0%，P =.63）。