At a glance
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Single- vs. Double-balloon Enteroscopy in Small Bowel Diagnostics: A Randomized Controlled Single-blind Multicenter Trial
In Brief
A clinical study evaluating Double-balloon procedure (DBE) and Single-balloon procedure (SBE) for Gastrointestinal Diseases. Completed, enrolled 150 participants across 3 sites in 3 countries.
Detailed Summary
Background: The small bowel has been a black box for gastrointestinal (GI) endoscopy as, until recently, most of the small bowel was not accessible with conventional endoscopes. Double-balloon enteroscopy (DBE) is an endoscopic procedure for visualizing the entire small bowel. The method was first described by Yamamoto and colleagues in 2001. Both endoscopic diagnosis and treatment can be easily performed using DBE. The first larger series, recently published, demonstrate that DBE is feasible in visualizing large parts of the small bowel. Although DBE has widely been used routinely for examining the small intestine there are a few issues which may limit its use. The preparation and handling of the DBE-endoscope is often interpreted as being complex (such as attaching the balloon to the tip of the endoscope, inflating/deflating the two balloon systems). Recently, a novel balloon enteroscope system has been developed using only a single balloon (single balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and treatment of the small bowel. The endoscopist needs to manipulate only one single balloon; thereby, time and complexity for preparation of the system and for the examination itself may be reduced. However, the new SBE system may be less efficient for deep intubation of the small bowel and may cause adverse effects due to the hooking of the endoscope during straightening of the endoscope. Study Aim: The primary aim of the present study is to compare the new SBE system with the standard DBE system with respect to completeness of visualisation and insertion depth of the small bowel, as well as complications during the procedure.
Study Details
Timeline
Interventions
Double-balloon procedure (DBE): DBE is performed using the DBE T-type endoscope system (Fujinon Inc, Japan), as described in the literature. The DBE endoscope consist of a 200-cm long video endoscope with an outer diameter of 8.5 mm and a flexible overtube with a length of 145 cm and an outer diameter of 12 mm. Latex balloons are attached to both the endoscope and the overtube. These balloons are inflated and deflated during insertion, as described elsewhere in detail (2,3).
Single-balloon procedure (SBE): SBE is performed using the SBE endoscope system (SIF-Q180, Olympus Optical Co., Ltd., Tokyo, Japan). The SBE endoscope consist of a 200-cm long video endoscope with an outer diameter of 9.2 mm and a flexible overtube with a length of 140 cm and an outer diameter of 13.2 mm. One single balloon is attached to the the tip of the overtube. The insertion process follows the method used for DBE, but instead of inflation of the endoscope balloon, the tip of the endoscope is angulated at straightening