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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Role of Enteroscopy
• Intervention / Treatment: Device: Enteroscopy

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).

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Amira Mohammed, assistant; Phone Number: 01012760437; Email: amiramohmad@gmail.com
• Study Contact Backup: Name: Nahed Makhlouf, Professor; Phone Number: 01003611626; Email: nahedmak@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: Role of enteroscopy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No