SINGLE-01 号研究：一项随机对照试验，旨在比较新型插入深度确定方法指导下单、双气囊小肠镜的疗效和插入深度。
SINGLE-01: a randomized, controlled trial comparing the efficacy and depth of insertion of single- and double-balloon enteroscopy by using a novel method to determine insertion depth.
机构信息
Department of Gastroenterology, St. Vincent's Hospital, Melbourne, Victoria, Australia.
出版信息
Gastrointest Endosc. 2012 Nov;76(5):972-80. doi: 10.1016/j.gie.2012.06.033. Epub 2012 Sep 12.
BACKGROUND
Single-balloon enteroscopy (SBE) was introduced as an alternative to double-balloon enteroscopy (DBE) for the investigation and management of small-bowel conditions. To date, there is only 1 randomized, controlled trial comparing SBE and DBE in a Western population.
OBJECTIVE
To compare the 2 instruments in a Western population to assess for differences in clinical outcomes and insertion depth (ID). A novel method to determine ID by counting folds on withdrawal was used.
DESIGN
Multicenter, randomized, controlled trial.
SETTING
University hospitals in Melbourne and Sydney, Australia.
PATIENTS
Patients with suspected or proven small-bowel disease.
INTERVENTIONS
SBE and DBE.
MAIN OUTCOME MEASUREMENT
The primary endpoint was diagnostic yield (DY). Secondary endpoints were therapeutic yield (TY), procedure times, and ID. An intention-to-treat analysis was performed.
RESULTS
A total of 116 patients were screened, and 107 patients were enrolled between July 2008 and June 2010, in whom 119 procedures were undertaken (53 SBEs and 66 DBEs). DY was 57% for SBE and 53% for DBE (P = .697). TY was 32% for SBE and 26% for DBE (P = .490). The median enteroscopy times were identical for SBE and DBE at 60 minutes. The mean ID by the fold-counting method for antegrade procedures was 201.1 folds for SBE and 258.6 folds for DBE (P = .046). After multiple comparisons adjustment, this difference did not reach statistical significance. Mean IDs by using the visual estimation method for SBE and DBE were, respectively, 72.1 cm and 75.2 cm (P = .835) for retrograde procedures and 203.8 cm and 234.1 cm (P = .176) for antegrade procedures.
LIMITATIONS
Unable to reach target sample size, mostly single-center recruitment, novel method to determine ID, which requires further validation.
CONCLUSIONS
SBE has DY, TY, and procedure times similar to those of DBE. There were no statistically significant differences in ID between SBE and DBE. By using the fold-counting method for antegrade procedures, the estimated IDs for SBE and DBE were 201.1 folds versus 258.6 folds (P = .046; P = not significant after adjustment for multiple comparisons). (
CLINICAL TRIAL REGISTRATION NUMBER
ACTRN12609000917235.).
背景
单气囊小肠镜（SBE）作为双气囊小肠镜（DBE）的替代方法，用于检查和治疗小肠疾病。迄今为止，仅有 1 项比较 SBE 和 DBE 在西方人群中的随机对照试验。
目的
比较这两种仪器在西方人群中的差异，评估临床结果和插入深度（ID）。采用一种新的通过计数退镜时的肠襻来确定 ID 的方法。
设计
多中心、随机、对照试验。
地点
澳大利亚墨尔本和悉尼的大学医院。
患者
疑似或确诊小肠疾病的患者。
干预措施
SBE 和 DBE。
主要观察指标
主要终点是诊断率（DY）。次要终点是治疗率（TY）、手术时间和 ID。采用意向治疗分析。
结果
共筛选了 116 例患者，2008 年 7 月至 2010 年 6 月期间有 107 例患者入组，其中 119 例患者接受了检查（53 例 SBE 和 66 例 DBE）。SBE 的 DY 为 57%，DBE 的 DY 为 53%（P =.697）。SBE 的 TY 为 32%，DBE 的 TY 为 26%（P =.490）。SBE 和 DBE 的经内镜逆行胰胆管造影术时间中位数相同，均为 60 分钟。SBE 前向进镜时通过肠襻计数法的平均 ID 为 201.1 个，DBE 为 258.6 个（P =.046）。经过多次比较调整后，这种差异没有达到统计学意义。SBE 和 DBE 后向进镜时使用视觉估计法的平均 ID 分别为 72.1cm 和 75.2cm（P =.835），SBE 和 DBE 前向进镜时的平均 ID 分别为 203.8cm 和 234.1cm（P =.176）。
局限性
无法达到目标样本量，主要是单中心招募，确定 ID 的新方法需要进一步验证。
结论
SBE 的诊断率、治疗率和手术时间与 DBE 相似。SBE 和 DBE 的 ID 无统计学差异。采用前向进镜的肠襻计数法，SBE 和 DBE 的估计 ID 分别为 201.1 个和 258.6 个（P =.046；P = 多次比较调整后无统计学意义）。（临床试验注册号：ACTRN12609000917235.）。
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