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

NCT ID: NCT04288882

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2023-09-30

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.

Detailed 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).

Conditions

Role of Enteroscopy

Study Design

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

Interventions

Enteroscopy

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amira Mohammed Abdel Mowgod

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Amira Mohammed, assistant

Role: CONTACT

amiramohmad@gmail.com

01012760437

Nahed Makhlouf, professor

Role: CONTACT

nahedmak@yahoo.com

01003611626

References

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.

Reference Type: BACKGROUND

PMID: 30997580 (View on PubMed)

Other Identifiers

Role of enteroscopy

Identifier Type: -

Identifier Source: org_study_id