Single- Versus Double-balloon Enteroscopy in Small Bowel Diagnostics

NCT00708253 | Completed DMC

• 1 other identifier: SBE-DBE_2008
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Gastrointestinal Diseases

Keywords

balloon assisted enteroscopy; single balloon enteroscopy; double balloon enteroscopy; insertion depth

Outcome Measures

Primary Outcomes (1)

• Primary endpoint: Comparison of completeness of visualization of the small bowel by combination of upper and lower balloon enteroscopy

  12 months

Secondary Outcomes (1)

• 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.

  12 months

Study Arms (2)

SBE

ACTIVE COMPARATOR

Device: Single-balloon procedure (SBE)

DBE

ACTIVE COMPARATOR

Device: Double-balloon procedure (DBE)

Interventions

Double-balloon procedure (DBE) DEVICE

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).

DBE

Single-balloon procedure (SBE) DEVICE

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

SBE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age under 18 years
• Inability to understand information for participation
• Refusal of participation

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (3)

University of Muenster, Dept. of Medicine B

Münster, 48149, Germany

Location

Erasmus University Medical Center, Dept. of Gastroenterology and Hepatology

Rotterdam, Netherlands

Location

Rikshospitalet University Hospital, Dept. of Medicine

Oslo, 0027, Norway

Location

Related Publications (7)

• 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. doi: 10.1067/mge.2001.112181.

  PMID: 11174299 BACKGROUND

• 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. doi: 10.1055/s-2005-870126.

  PMID: 16010603 BACKGROUND

• 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. doi: 10.1016/s0016-5107(05)01586-5.

  PMID: 15990821 BACKGROUND

• 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. doi: 10.1055/s-2007-966990.

  PMID: 18072057 BACKGROUND

• Hartmann D, Eickhoff A, Tamm R, Riemann JF. Balloon-assisted enteroscopy using a single-balloon technique. Endoscopy. 2007 Feb;39 Suppl 1:E276. doi: 10.1055/s-2007-966616. Epub 2007 Oct 24. No abstract available.

  PMID: 17957636 BACKGROUND

• 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. doi: 10.1055/s-2007-966976. Epub 2007 Dec 4.

  PMID: 18058613 BACKGROUND

• 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.

  RESULT

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Michael Bretthauer, M.D., PhD

  Rikshospitalet University Hospital, Dept. of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 2, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 12, 2010

Record last verified: 2010-04

Locations

NO (1); DE (1); NL (1)