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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01065324
Other study ID # 200812154R
Secondary ID
Status Recruiting
Phase N/A
First received February 8, 2010
Last updated February 8, 2010
Start date February 2010
Est. completion date December 2012

Study information

Verified date February 2010
Source National Taiwan University Hospital
Contact TC Lee, MD
Email johnlee0212@gmail.com
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2012
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- adult patients with clinical suspicions of small intestinal lesions in need of balloon-assisted enteroscopy examinations

- signed written informed consents

Exclusion Criteria:

- Patients with active infection or receiving systemic (oral or intravenous) antibiotics within recent 3 months (this may decrease effect of bacterial translocation) or taking drugs that may affect renal function within 3 months

- Unstable health condition for balloon-assisted enteroscopy (unstable hemodynamics, severe cardiopulmonary compromise)

- Pregnancy

- known allergy to lactulose, mannitol

- Refuse to sign written informed consent of this study.

- patients would be advised to hold prokinetic agents

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan E-Da Hospital Kaohsiung
Taiwan NTUH Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary molecular bacteremia 7d Yes
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