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Clinical Trial 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.


Clinical Trial Description

The small intestine is very essential for digestion and absorption and is presented between the stomach and large intestine. Because of its anatomical position, the small intestine was named as a "blind area" leading to difficulty in diagnosis of small bowel disease. The advant of ballon-assisted enteroscopy facilitates the management of the small bowel diseases. There are several causes of obscure small intestinal disorders, which are Angioectasia (20-55%), small bowel tumours (10-20%), Cameron erosions (5-15%), NSAID enteropathy (5%), Dieulafoy lesion (2-3%), Crohn's disease (2-10%), Coeliac disease( 2-5 %), Meckel's diverticulum (2-5%), duodenal varices (1-5%), gastric antral vascular ectasia (GAVE) (1-2%), Ectopic varices (1-2%), Portal hypertensive enteropathy 1-2% (but 60-70% in those with portal hypertension), Radiation enteritis (<1% ). Obscure gastrointestinal bleeding (OGIB) was the most common indication for enteroscopry and is defined as a bleeding from an unknown site after a negative evaluation of the GI tract with esophagogastroduodenoscopy (EGD) and ileocolonoscopy. OGIB represents about 5% of patients presenting with GI bleeding. OGIB isthe most common indication for enteroscopry, whatever the age groups, but the proportion of patients performing enteroscopy for OGIB was higher in elderly patients. Young patients were indicated for enteroscopy for other complains, such as abdominal pain, or suspicious small-bowel tumor. Egyptian study was done and identified that the source of OGIB in the small intestine represents 69.2%, with negative DBE findings in 30.8% and the most common lesions were angioectasias followed by GI tumours (30.8%, 19.2%, respectively). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04288882
Study type Observational
Source Assiut University
Contact Amira Mohammed, assistant
Phone 01012760437
Email amiramohmad@gmail.com
Status Not yet recruiting
Phase
Start date March 2020
Completion date September 2023