Role of Balloon-Assisted Enteroscopy (BAE) in Small Intestinal Disorders

Role of Enteroscopy Clinical Trial

Official title:

Role of Balloon-Assisted Enteroscopy (BAE) in Diagnosis and Treatment of Small Intestinal Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04288882
• Other study ID #: Role of enteroscopy
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: September 2023

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: Amira Mohammed, assistant
• Phone: 01012760437
• Email: amiramohmad[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2023
• Est. primary completion date: March 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:All male and female patients aged =18 - =80 year-old with suspected small intestinal disorders referred to the above Unit for BAE in the period between March 2020 till March 2022 inclusive irrespective of indication will be included in this study.

Exclusion Criteria:Those who are <18 years-old and >80 years-old, those with gastrointestinal obstruction, preganat ladies, and those who fail to provide consent will be excluded.

Related Conditions & MeSH terms

• Intestinal Diseases
• Role of Enteroscopy

Intervention

Device:
• Enteroscopy
Role of Balloon-Assisted Enteroscopy (BAE) in management of Small Intestinal Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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