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| Sponsor: | University Hospital Muenster |
|---|---|
| Information provided by: | University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT00708253 |
Purpose
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.
| Condition | Intervention |
|---|---|
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Gastrointestinal Diseases |
Device: Double-balloon procedure (DBE) Device: Single-balloon procedure (SBE) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | Single- vs. Double-balloon Enteroscopy in Small Bowel Diagnostics: A Randomized Controlled Single-blind Multicenter Trial |
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2008 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: SBE |
Device: Single-balloon procedure (SBE)
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
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| Active Comparator: DBE |
Device: Double-balloon procedure (DBE)
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).
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Germany | |
| University of Muenster, Dept. of Medicine B | |
| Muenster, Germany, 48149 | |
| Netherlands | |
| Erasmus University Medical Center, Dept. of Gastroenterology and Hepatology | |
| Rotterdam, Netherlands | |
| Norway | |
| Rikshospitalet University Hospital, Dept. of Medicine | |
| Oslo, Norway, 0027 | |
| Principal Investigator: | Dirk Domagk, M.D. | University of Muenster, Dept. of Medicine B |
| Principal Investigator: | Lars Aabakken, M.D. | Rikshospitalet University Hospital, Dept. of Medicine |
| Principal Investigator: | Peter Mensink, M.D. | Erasmus University Medical Center, Dept. of Gastroenterology and Hepatology |
| Study Chair: | Michael Bretthauer, M.D., PhD | Rikshospitalet University Hospital, Dept. of Medicine |
More Information
| Responsible Party: | University Hospital Muenster, Dept. of Medicine B |
| ClinicalTrials.gov Identifier: | NCT00708253 History of Changes |
| Other Study ID Numbers: | SBE-DBE_2008 |
| Study First Received: | June 30, 2008 |
| Last Updated: | April 9, 2010 |
| Health Authority: | Germany: Ethics Commission |
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balloon assisted enteroscopy single balloon enteroscopy double balloon enteroscopy insertion depth |
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Gastrointestinal Diseases Digestive System Diseases |