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Single- Versus Double-balloon Enteroscopy in Small Bowel Diagnostics (SBE_vs_DBE)
This study has been completed.

First Received on June 30, 2008.   Last Updated on April 9, 2010   History of Changes
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
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

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Primary endpoint: Comparison of completeness of visualization of the small bowel by combination of upper and lower balloon enteroscopy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of small bowel insertion depth, time to complete visualization of the small bowel (combined approaches), patient discomfort, use of sedatives during the procedure, diagnostic yield, complications and adverse effects due to the procedure. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients referred for routine balloon enteroscopy where total enteroscopy is indicated
  • All individuals provide written informed consent before entering the trial

Exclusion criteria:

  • Age under 18 years
  • Inability to understand information for participation
  • Refusal of participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708253

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
Sponsors and Collaborators
University Hospital Muenster
Investigators
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

Publications:
Maaser C, Ullerich H, Menzel K, Domagk D, Lügering A, Domschke W, Kucharzik T. Double balloon enteroscopy - a useful diagnostic tool? Analysis of a large, non-selected cohort of patients regarding success and complication of double-balloon endoscopy (abstract). Gastroenterology 2006;130:A476.
Yamamoto H, Sekine Y, Sato Y, Higashizawa T, Miyata T, Iino S, Ido K, Sugano K. Total enteroscopy with a nonsurgical steerable double-balloon method. Gastrointest Endosc. 2001 Feb;53(2):216-20.
Ell C, May A, Nachbar L, Cellier C, Landi B, di Caro S, Gasbarrini A. Push-and-pull enteroscopy in the small bowel using the double-balloon technique: results of a prospective European multicenter study. Endoscopy. 2005 Jul;37(7):613-6.
May A, Nachbar L, Ell C. Double-balloon enteroscopy (push-and-pull enteroscopy) of the small bowel: feasibility and diagnostic and therapeutic yield in patients with suspected small bowel disease. Gastrointest Endosc. 2005 Jul;62(1):62-70.
Domagk D, Bretthauer M, Lenz P, Aabakken L, Ullerich H, Maaser C, Domschke W, Kucharzik T. Carbon dioxide insufflation improves intubation depth in double-balloon enteroscopy: a randomized, controlled, double-blind trial. Endoscopy. 2007 Dec;39(12):1064-7.
Hartmann D, Eickhoff A, Tamm R, Riemann JF. Balloon-assisted enteroscopy using a single-balloon technique. Endoscopy. 2007 Feb;39 Suppl 1:E276. Epub 2007 Oct 24. No abstract available.
Tsujikawa T, Saitoh Y, Andoh A, Imaeda H, Hata K, Minematsu H, Senoh K, Hayafuji K, Ogawa A, Nakahara T, Sasaki M, Fujiyama Y. Novel single-balloon enteroscopy for diagnosis and treatment of the small intestine: preliminary experiences. Endoscopy. 2008 Jan;40(1):11-5. Epub 2007 Dec 4.

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

Keywords provided by University Hospital Muenster:
balloon assisted enteroscopy
single balloon enteroscopy
double balloon enteroscopy
insertion depth

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012