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

Primary Purpose

Small Intestine Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Double balloon enteroscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Small Intestine Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Enteroscopy

    Arm Description

    Double balloon enteroscopy

    Outcomes

    Primary Outcome Measures

    Diagnostic role of enteroscopy in small intestinal diseases
    To assess frequency of benign and malignant lesions of small intestine by histopathpathological examination of the obtained biopsy

    Secondary Outcome Measures

    Side effects and complications of enteroscopy
    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

    Full Information

    First Posted
    July 5, 2022
    Last Updated
    July 20, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05470946
    Brief Title
    Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital
    Official Title
    Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To identify the role of enteroscopy in diagnosis and treatment of small intestinal diseases.
    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: Autoimmune causes: They include celiac disease, Crohn's disease, and other autoimmune enteropathies that affect one or several areas of the intestine. Drugs: Of the antihypertensive, especially olmesartan, NSAIDs, immunosuppressant, such as azathioprine, methotrexate as well as the checkpoint inhibitors, such as nivolumab 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). 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. 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Intestine Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Enteroscopy
    Arm Type
    Other
    Arm Description
    Double balloon enteroscopy
    Intervention Type
    Device
    Intervention Name(s)
    Double balloon enteroscopy
    Intervention Description
    Double balloon enteroscopy (EN-580T, Fujifilm, Japan)
    Primary Outcome Measure Information:
    Title
    Diagnostic role of enteroscopy in small intestinal diseases
    Description
    To assess frequency of benign and malignant lesions of small intestine by histopathpathological examination of the obtained biopsy
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Side effects and complications of enteroscopy
    Description
    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
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maiada Ibrahim
    Phone
    01068388643
    Email
    maiada145@yahoo.com

    12. IPD Sharing Statement

    Citations:
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    26114907
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    Genta RM, Sonnenberg A. The yield of colonic biopsy in the evaluation of chronic unexplained diarrhea. Eur J Gastroenterol Hepatol. 2015 Aug;27(8):963-7. doi: 10.1097/MEG.0000000000000365.
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    Citation
    Ghoshal UC, Gwee KA. Post-infectious IBS, tropical sprue and small intestinal bacterial overgrowth: the missing link. Nat Rev Gastroenterol Hepatol. 2017 Jul;14(7):435-441. doi: 10.1038/nrgastro.2017.37. Epub 2017 May 17.
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    Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital

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