Trials / Unknown
UnknownNCT01065324
Balloon-assisted Enteroscopy and Bacteria
Intestinal Barrier Permeability Defects, Recovery, and Risk of Bacterial Translocation Induced After Deep Intestinal Manipulation by Balloon-assisted Enteroscopy: From Basic to Clinical Research
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- National Taiwan University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Accepted
Summary
1. Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal diseases. 2. Deep enteroscopy made possible by balloon expansion and manipulation of small intestines. 3. However, whether intestinal barrier injured during BAE predispose patients to bacteremia or clinical relevant infection is not studied. 4. We will also examine relevant patient factors.
Detailed description
The newly developed balloon-assisted enteroscopy systems allow insertion of the enteroscopy deeply into the small intestines by fixation of the soft, redundant small intestines with an inflatable balloon over the tip of the overtube. However, the inflation of balloon might stimulate the intestinal mucosa, and the deep manipulation of intestinal segments might also compromise the intestinal barrier function. According to our preliminary experience of balloon-assisted enteroscopy (which is among the first groups in Taiwan), we experienced a significant case of suspected post-procedural bactermia patient. Besides, there is also a published case report from the UK reporting Streptococcus milleri bacteremia which is suspected as bacterial translocation after balloon-assisted enteroscopy. However, currently there is no original study focusing on the intestinal barrier / permeability defects or bacterial translocation. This is a timely and novel research topic in the current developing era of balloon-assisted enteroscopy.
Conditions
Timeline
- Start date
- 2010-02-01
- Completion
- 2012-12-01
- First posted
- 2010-02-09
- Last updated
- 2010-02-09
Locations
2 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01065324. Inclusion in this directory is not an endorsement.