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临床试验/NCT01942863
NCT01942863已完成不适用

Effect of Water Exchange Method on Intubation Depth and Diagnostic Yield in Patients Undergoing Single-balloon Enteroscopy: a Prospective, Randomized, Controlled, Patient-blind Trial.

Air Force Military Medical University, China2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
2
主要终点
Complete enteroscopy rates

研究概览

简要总结

Enteroscopy, including double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE) currently, have shown good performances in small bowel diagnostics and seem to be useful in the clinical routine. However, enteroscopy is a time-consuming procedure. During common practice, large volumes of air need to be insufflated for good visualization. It leads to significant distention of the small bowel during the examination, which makes further intubation more technically challenging because of the formation of distended bowel loops and acute angulations and limits the maximal intubation length. According to the published data, the oral insertion depth of different kinds of enteroscopy is limited to approximately 240 cm. The total examination rate range form 18% to 86% for DBE and 0% to 11% for SBE.

It is thought that the intubation depth in small bowel determines the diagnostic yield and the following treatment. The deeper the enteroscopy is advanced into the small bowel, the more lesions may be found and treated. In order to improve the intubation depth of balloon enteroscopy, several methods, such as carbon dioxide insufflation and decompression side tube-equipped device, have been tried and showed positive effects. CO2 insufflation could also reduce severe pain during DBE and residual gas retention after the procedure because of rapid absorption. However, it is not known how much CO2 insufflation can decrease the distention of small bowel and the formation of bowel loops.

Recently, the use of water infusion in lieu of air insufflation has been shown to facilitate completion of colonoscopy, even in potentially difficult patients with prior abdominal or pelvic surgery. Water exchange method obviates excessive lengthening of the colon and the formation of acute angulation, which may cause less pain and easier intubation during scope insertion. Recently, water exchange method was also tried in two patients undergoing SBE via antegrade route in our center. Distal ileum 8cm near to ICV and the cecum was reached respectively (unpublished data), indicating water exchange be a useful method for deep intubation of SBE.

Here a prospective, randomized, controlled trial was designed to investigate whether, compared with CO2 insufflation method, water exchange method could increase the intubation depth and diagnostic yield in patients undergoing SBE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Suspected small-bowel disease

排除标准

  • •Prior small-bowel surgery
  • •Total examination of small bowel not planned when image modalities showed
  • •lesions obviously located on duodenum, proximal jejunum or distal ileum
  • •High-risk esophageal varices
  • •Pregnancy or lactation
  • •Inability to tolerate sedation or general anesthesia because of comorbidities
  • •Inability to provide informed consent

研究组 & 干预措施

water exchange single balloon enteroscopy

Experimental

干预措施: water exchange single balloon enteroscopy (Procedure)

water exchange single balloon enteroscopy

Experimental

干预措施: Procedural Requirements (Other)

CO2 insufflation single balloon enteroscopy

Active Comparator

干预措施: CO2 insufflation single balloon enteroscopy (Procedure)

CO2 insufflation single balloon enteroscopy

Active Comparator

干预措施: Procedural Requirements (Other)

结局指标

主要结局

Complete enteroscopy rates

时间窗: up to one year

Definition of total visualization of small bowel: cecum was reached via antegrade route or antrum was reached via retrograde route; submucosal india ink was observed form 2rd SBE.

次要结局

  • Procedural time(up to one year)
  • Diagnostic yield(up to one year)
  • Adverse events(up to one year)
  • Oral insertion depth(up to one year)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

Associated professor

Air Force Military Medical University, China

研究点 (2)

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