Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai Institute of Digestive Disease, Shanghai, China.
Digestive Disease Centre, Showa University, Northern Yokohama Hospital, Yokohama, Japan.
Gut. 2014 Oct;63(10):1560-5. doi: 10.1136/gutjnl-2013-306069. Epub 2014 Mar 13.
The total enteroscopy rate of single-balloon enteroscopy (SBE) using air insufflation is not satisfactory, and whether carbon dioxide (CO2) insufflation increases the total enteroscopy rate of SBE is unknown. This randomised controlled trial aimed to determine whether CO2 insufflation facilitates the intubation depth and total enteroscopy rate of SBE.
A total of 214 eligible patients referred for SBE were randomised to receive either air or CO2 insufflation, and included in the intention-to-test (ITT) analysis. In addition, 199 patients in whom enteroscopy was completed were included in the per-protocol (PP) analysis. Both the patients and endoscopists were blinded, and the intubation depth and total enteroscopy rate were defined as the primary outcomes.
The CO2 group showed a superiority of intubation in the ITT analysis (oral route: 323.8±64.2 vs 238.3±68.6 cm; anal route: 261.6±74.2 vs 174.7±62.1 cm, both p<0.001), and the total enteroscopy rate (34.9% vs 17.6%, p=0.006). Similar results were obtained in a PP analysis for both outcomes. In addition, in the PP analysis, the addition of circumference after the procedure was less in the CO2 group (0.8±0.6 vs 3.3±1.8 cm, p=0.005) for the oral route. No serious complications were reported. The overall percentage of procedures with significant pathological findings was 52.8%; the rates were 58.5% and 47.2% (p=0.100, ITT analysis) in the CO2 and air groups, respectively.
CO2 insufflation improves the intubation depth and total enteroscopy rate in SBE with a good safety profile and acceptability compared with that of air, and thus is recommended for clinical utilisation.
ClinicalTrial.gov identifier: NCT01758900.
经单气囊小肠镜（SBE）采用空气注气的总进镜率并不令人满意，而二氧化碳（CO2）注气是否会增加 SBE 的总进镜率尚不清楚。本随机对照试验旨在确定 CO2 注气是否有助于 SBE 的插管深度和总进镜率。
共纳入 214 例符合条件的 SBE 患者，随机分为接受空气或 CO2 注气组，并纳入意向治疗（ITT）分析。此外，199 例完成进镜的患者纳入方案意向（PP）分析。患者和内镜医生均设盲，插管深度和总进镜率定义为主要结局。
CO2 组在 ITT 分析中显示出插管的优越性（口侧：323.8±64.2 比 238.3±68.6 cm；肛侧：261.6±74.2 比 174.7±62.1 cm，均 p<0.001），且总进镜率（34.9%比 17.6%，p=0.006）也更高。这两个结局在 PP 分析中也得到了相似的结果。此外，在 PP 分析中，CO2 组在口侧的操作后周长增加较少（0.8±0.6 比 3.3±1.8 cm，p=0.005）。未报告严重并发症。具有显著病理发现的手术总体百分比为 52.8%；CO2 组和空气组分别为 58.5%和 47.2%（p=0.100，ITT 分析）。
与空气相比，CO2 注气可改善 SBE 的插管深度和总进镜率，且具有良好的安全性和可接受性，因此推荐临床应用。
ClinicalTrial.gov 标识符：NCT01758900。
