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
About this trial
This is an interventional diagnostic trial for Small Intestine Disease
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
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
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:
PubMed Identifier
32419915
Citation
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Results Reference
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PubMed Identifier
26114907
Citation
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.
Results Reference
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PubMed Identifier
28513629
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.
Results Reference
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PubMed Identifier
27374798
Citation
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Results Reference
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PubMed Identifier
28817113
Citation
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PubMed Identifier
23777610
Citation
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Results Reference
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PubMed Identifier
35310743
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital
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