Role of Balloon-Assisted Enteroscopy (BAE) in Small Intestinal Disorders
1 other identifier
observational
80
0 countries
N/A
Brief Summary
Overall Aim: This study is designed to assess the role of ballon-assisted enteroscopy in the management of obscure small intestinal disorders in a tertiary-care center in Upper Eygpt. Specific objectives:
- 1.Evaluate the technical success rate and causes of the procedure in our locality
- 2.Explore the value and safety of BAE in the diagnose and treatment of suspected small bowel diseases.
- 3.Assess patients' and endoscopists' satisfaction related to the procedure.
- 4.Define the indications, diagnostic yield and appropriatness of BAE in our center.
- 5.Determine the value of enteroscopy-obtained biopsy samples in the diagnosis.
- 6.Perform a cost analysis of BAE in relation to its diagnostic value/yield.
- 7.Report the therapeutic role of BAE in different small intestinal disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedFebruary 28, 2020
February 1, 2020
2 years
February 26, 2020
February 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Role of Balloon-Assisted Enteroscopy (BAE) in Diagnosis and Treatment of Small Intestinal Disorders
This study is designed to assess the role of ballon-assisted enteroscopy in the management of obscure small intestinal disorders in a tertiary-care center in Upper Eygpt.
baseline
Interventions
Role of Balloon-Assisted Enteroscopy (BAE) in management of Small Intestinal Disorders
Eligibility Criteria
After obtaining the appropriate consents, data pertaining to clinical history, physical examination and baseline laboratory investigations (complete blood count, kidney function, coagulation profile) for all cases of obscure small intestinal disorders. CT abdomen, conventional upper GI endoscopy and colonoscopy in addition to other modalities as the CT scan and angiography will be done for every patient as appropriate. All patients will be subjected to the BAE if these modalities are negative. BAE will be performed in an outpatient or inpatient setting under general anesthesia, although some patients may require only conscious sedation. Most procedures will be performed through the mouth (antegrade), although the (retrograde) approach, through the rectum, may be done resorted to allow better access to suspected lesions in the lower part of the small bowel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hashimoto R, Nakahori M, Matsuda T. Impact of Urgent Double-Balloon Enteroscopy on the Short-Term and Long-Term Outcomes in Overt Small Bowel Bleeding. Dig Dis Sci. 2019 Oct;64(10):2933-2938. doi: 10.1007/s10620-019-05627-1. Epub 2019 Apr 17.
PMID: 30997580BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
February 26, 2020
First Posted
February 28, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2022
Study Completion
September 1, 2023
Last Updated
February 28, 2020
Record last verified: 2020-02