CClinicalTrials.gg
Status unknownNCT04288882Updated Feb 28, 2020

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

An observational study in Role of Enteroscopy, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 80 Years
Sex
All
01

Study 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.
Read the 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).

02

Conditions studied

  • Role of Enteroscopy

Browse trials for

03

In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's planned enrollment of 80 is below the median of 140 across 377 observational studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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.

Eligibility 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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • DeviceEnteroscopy

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

06

What researchers measure

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.

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 30997580 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04288882
Lead sponsor
Assiut University
Responsible party
Amira Mohammed Abdel Mowgod (Doctor, Assiut University) — Principal investigator
First posted
Feb 28, 2020
Start date
Mar 2020 (estimated)
Primary completion
Mar 2022 (estimated)
Completion
Sep 2023 (estimated)
Last update
Feb 28, 2020

Study contacts

Amira Mohammed, assistant
Contact
amiramohmad@gmail.com
01012760437
Nahed Makhlouf, professor
Contact
nahedmak@yahoo.com
01003611626

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion