Balloon-assisted Enteroscopy and Bacteria

NCT ID: NCT01065324

Last Updated: 2010-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-12-31

Brief 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

Enteritis; Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Anally inserted enteroscopy group

Anally inserted enteroscopy group

No interventions assigned to this group

Orally inserted enteroscopy group

Orally inserted enteroscopy group

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

NTUH

Principal Investigators

TC Lee, MD

Role: PRINCIPAL_INVESTIGATOR

NTUH

Locations

E-Da Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

NTUH

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

TC Lee, MD

Role: CONTACT

johnlee0212@gmail.com

Facility Contacts

CM Tai, MD

Role: primary

chimingtai@gmail.com

TC LEE, MD

Role: primary

johnlee0212@gmail.com

Other Identifiers

200812154R

Identifier Type: -

Identifier Source: org_study_id