Single- vs. double-balloon enteroscopy in small bowel diagnostics: A randomized controlled single-blind multicenter trial

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 (1). 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
(2-4). 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.

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.

The study is designed as a multicenter randomized controlled trial.

Nature and extent of the burden: There is minimally extent of the burden by
asking the patient to fill in a quastionnaire.


Risk: The risk associaiated with participation is very low. The risk for an
inflammation of pancreas is lower than the standard procedure (DBE). The risk
for mucosal damages due to the hooking of the endoscope during straightening of
the endoscopist is in theory higher. The latter risk is estimated low and not
significant.