Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital

July 20, 2022 updated by: Maiada Mohie Eldin Ibrahim, Assiut University
To identify the role of enteroscopy in diagnosis and treatment of small intestinal diseases.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The small bowel is vital for digestion and absorption and is located between the stomach and large bowel. Because of its anatomical position, the small bowel was originally thought to be a "blind area" beyond the reach of ordinary endoscopic examination, leading to difficulty in diagnosing smallbowel disease.

Diseases that affect the intestinal wall are called enteropathies and can be associated with chronic diarrhea, which clinically presents in that group of patients as malabsorption syndrome and can be divided into:

  1. Autoimmune causes: They include celiac disease, Crohn's disease, and other autoimmune enteropathies that affect one or several areas of the intestine.
  2. Drugs: Of the antihypertensive, especially olmesartan, NSAIDs, immunosuppressant, such as azathioprine, methotrexate as well as the checkpoint inhibitors, such as nivolumab
  3. Radiotherapy (RT): Up to 20% of the patients exposed to RT can develop intestinal damage; it typically occurs between 1 and 6 years, post-exposure, and is dose-dependent, usually presenting when the dose exceeds5000 cGy (centi-Gray).
  4. Infectious causes: They include tropical sprue, SIBO, giardiasis, Whipple's disease, human immunodeficiency virus infection and associated opportunistic germs, tuberculosis, post-viral enteropathies, and lymphocytic enteritis associated with Helicobacter pylori infection.
  5. Infiltrative and neoplastic disorders: They include eosinophilic enteritis, collagenous sprue, amyloidosis, T cell or B cell lymphoma associated with enteropathies, ymphoproliferative intestinal lymphoma, and some vasoactive substance-producing neuroendocrine tumors, especially gastrinomas, VIPomas, and intestinal carcinoid tumors.
  6. Miscellaneous causes: They include conditions as diverse as peptic duodenitis, food allergies, malnutrition, lymphangiectasis, common variable immunodeficiency, or idiopathic sprue, which can also cause malabsorption syndrome

For detecting neoplastic and inflammatory diseases, endoscopy is a powerful tool. However, the diagnostic yield of a routine colonoscopy examination has been reported to be as low as 15%-30% even when an appropriate histopathological examination is added with multiple biopsy specimens.

Capsule endoscopy is an innovative method for diagnosing smallbowel disease. The reported positivity rate of capsule endoscopy for diagnosing smallbowel disease is approximately 45-81% with an accuracy rate of approximately 20-30%. However, biopsy is not possible using this approach, the precise lesion location cannot be determined, and endoscopic therapy is not possible, which limit its use.

Doubleballoon enteroscopy partly overcomes the deficiencies of capsule endoscopy, enabling examination of the entire small bowel while making biopsy and therapy possible as in stenosis dilation, extracting retained capsule endoscopy, and controlling bleeding.

The diagnostic rate of doubleballoon enteroscopy for smallbowel disease ranges from 82.4% to 86.8%.

Obtaining multiple biopsy samples from gastrointestinal mucosa is important for the diagnosis of microscopic colitis, amyloidosis, eosinophilic gastroenteritis, and celiac disease since an endoscopic examination is not sensitive enough to detect characteristic findings associated with these diseases.

Approximately 0.3-10% of individuals with celiac disease (CD) will develop refractory CD (RCD), which is associated with pre-malignant/malignant lesions which can affect anywhere along the length of the small intestine such as ulcerative jejunitis and enteropathy associated T cell lymphoma (EATL). Therefore, endoscopic evaluation of the entire length of the small bowel is essential.

Over 95% of the patients with eosinophilic gastroenteritis (EGE) reportedly have detectable endoscopic abnormalities such as multiple erosions with surrounding redness so the diagnosis of EGE is based on symptoms and eosinophilic infiltration of tissues, and a biopsy with a balloon endoscope is necessary to evaluate the histology of the small intestine.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • All patients will undergo gastroscopy, colonoscopy, abdominal computed tomography and/or magnetic resonance imaging, or radionuclide examination without a clear diagnosis will be subjected to enteroscopy including:

    • patients with obscure digestive tract bleeding
    • patients with obscure diarrhea
    • patients with obscure abdominal pain
    • patients with obscure weight loss
    • patients with obscure intestinal obstruction • Patients with imaging suggesting small intestinal lesions

Exclusion Criteria:

  • Patients who aren't eligible for anesthesia e.g.: severe cardiovascular, respiratory dysfunction or coagulopathy.
  • Patients who aren't eligible for endoscopy e.g.: fulminant colitis, acute perforation and peritonitis, and impending perforation, intestinal obstruction, recent intestinal surgery.
  • Patient's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Enteroscopy
Double balloon enteroscopy
Device: Double balloon enteroscopy
Double balloon enteroscopy (EN-580T, Fujifilm, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic role of enteroscopy in small intestinal diseases
Time Frame: 2 years
To assess frequency of benign and malignant lesions of small intestine by histopathpathological examination of the obtained biopsy
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects and complications of enteroscopy
Time Frame: 2 years
To report the rate of any side effects and/or complications of the procedure such as perforation and to report rate of incomplete enteroscopy and its causes
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diagnostic 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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