Single- Versus Double-balloon Enteroscopy in Small Bowel Diagnostics

Study Overview
=================
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.

Detailed Description
-----------------
Study design: The study is designed as a multicenter randomized controlled trial. The participating centers are Rikshospitalet University Hospital (Dept. of Gastroenterology), Oslo, Norway, University Hospital Muenster (Dept. of Medicine B), Muenster, Germany and Erasmus Medical Center, Rotterdam, The Netherlands. Randomization: Randomization to SBE or DBE is performed on basis of the individual participant. Equally large groups are randomized using block randomization (blocks of six patients) for each of the participating centers. Randomization (using SPSS statistical software package) is performed by an independent researcher, who is not part of the endoscopy team. Double-balloon procedure: 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. Single-balloon procedure: 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. Ethics: The regional ethics committees of the participating centers will be asked for approval of the study protocol. Power analysis: The present study is a non-inferiority study, aiming on showing equality between the two endoscope systems with regard to the main endpoints. A pilot study including 20 patients in each group will be performed since there is no data in present literature with respect to the main endpoints. The difference in percentage of complete visualization between the two groups will be used as the power-driving endpoint. The results of the pilot study will then be used for power calculation of the study applying the no inferiority-thesis. P-values of < 0.05 will be considered statistically significant. Ad addendum: The manufacturer of one of the instruments on the present trial (Olympus) approached the investigators in late January 2009 about a possible risk of increased adverse events with the Olympus endoscope. The company was not aware of any details regarding the nature of these events or the magnitude of this potential risk, as the warning was solely based on unpublished rumors in the GI community. To prevent participants in the present trial from any harm, the investigators decided to perform an interim analysis including all patients included in the trial until February 1, 2009, to rule out possible adverse events or poor performance in one or both of the involved treatment arms. No stopping rules apply for this interim analysis.

Official Title
-----------------
Single- vs. Double-balloon Enteroscopy in Small Bowel Diagnostics: A Randomized Controlled Single-blind Multicenter Trial

Conditions
-----------------
Gastrointestinal Diseases

Intervention / Treatment
-----------------
* Device: Double-balloon procedure (DBE)
* Device: Single-balloon procedure (SBE)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SBE<br> | Device: Single-balloon procedure (SBE)<br>* 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<br>|
| Active Comparator: DBE<br> | Device: Double-balloon procedure (DBE)<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint: Comparison of completeness of visualization of the small bowel by combination of upper and lower balloon enteroscopy |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
balloon assisted enteroscopy, single balloon enteroscopy, double balloon enteroscopy, insertion depth