Small Intestine DiseaseNCT05470946
Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital
A study testing Double balloon enteroscopy in people with Small Intestine Disease, run by Assiut University.
Trial summary
To identify the role of enteroscopy in diagnosis and treatment of small intestinal diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Small Intestine Disease
- What is being tested?
- Double balloon enteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
To identify the role of enteroscopy in diagnosis and treatment of small intestinal diseases.
Read the 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.
- Conditions
- Small Intestine Disease
- Being tested
- Double balloon enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double balloon enteroscopyDevice
Double balloon enteroscopy (EN-580T, Fujifilm, Japan)
| Study group | Role | What they receive |
|---|---|---|
| Enteroscopy | Other | Double balloon enteroscopy Receives: Device: Double balloon enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Small Intestine DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maiada Mohie Eldin Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470946
- Sponsor's protocol ID
- Diagnostic role of enteroscopy
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baggus EMR, Hadjivassiliou M, Cross S, Penny H, Urwin H, Watson S, Woodward JM, Sanders DS. How to manage adult coeliac disease: perspective from the NHS England Rare Diseases Collaborative Network for Non-Responsive and Refractory Coeliac Disease. Frontline Gastroenterol. 2019 Aug 8;11(3):235-242. doi: 10.1136/flgastro-2019-101191. eCollection 2020.
PubMed 32419915Genta 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.
PubMed 26114907Ghoshal 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.
PubMed 28513629ASGE Standards of Practice Committee; Gurudu SR, Bruining DH, Acosta RD, Eloubeidi MA, Faulx AL, Khashab MA, Kothari S, Lightdale JR, Muthusamy VR, Yang J, DeWitt JM. The role of endoscopy in the management of suspected small-bowel bleeding. Gastrointest Endosc. 2017 Jan;85(1):22-31. doi: 10.1016/j.gie.2016.06.013. Epub 2016 Jun 30. No abstract available.
PubMed 27374798Kamboj AK, Oxentenko AS. Clinical and Histologic Mimickers of Celiac Disease. Clin Transl Gastroenterol. 2017 Aug 17;8(8):e114. doi: 10.1038/ctg.2017.41.
PubMed 28817113Makkar R, Lopez R, Shen B. Clinical utility of retrograde terminal ileum intubation in the evaluation of chronic non-bloody diarrhea. J Dig Dis. 2013 Oct;14(10):536-42. doi: 10.1111/1751-2980.12082.
PubMed 23777610Kinoshita Y, Ariyoshi R, Fujigaki S, Tanaka K, Morikawa T, Sanuki T. Endoscopic diagnosis of chronic diarrhea. DEN Open. 2021 Sep 28;2(1):e53. doi: 10.1002/deo2.53. eCollection 2022 Apr.
PubMed 35310743Mizumoto N, Sasaki Y, Abe Y, Yagi M, Kon T, Onozato Y, Sakai T, Ito M, Umehara M, Ueno Y. Small-bowel Capsule Endoscopic Features in Patients with Eosinophilic Gastroenteritis: Three Case Reports. Intern Med. 2021 Sep 15;60(18):2961-2965. doi: 10.2169/internalmedicine.6935-20. Epub 2021 Mar 29.
PubMed 33776012Nakano M, Oka S, Tanaka S, Igawa A, Kunihara S, Ueno Y, Ito M, Chayama K. Indications for Small-bowel Capsule Endoscopy in Patients with Chronic Abdominal Pain. Intern Med. 2017;56(12):1453-1457. doi: 10.2169/internalmedicine.56.7458. Epub 2017 Jun 15.
PubMed 28626168Rowinski SA, Christensen E. Epidemiologic and therapeutic aspects of refractory coeliac disease - a systematic review. Dan Med J. 2016 Dec;63(12):A5307.
PubMed 27910801Shin JY, Park IS, Bang BW, Kim HK, Shin YW, Kwon KS. A Case of Primary Small Bowel Melanoma Diagnosed by Single-Balloon Enteroscopy. Clin Endosc. 2017 Jul;50(4):395-399. doi: 10.5946/ce.2016.153. Epub 2017 Jun 2.
PubMed 28783927Takenaka K, Ohtsuka K, Kitazume Y, Matsuoka K, Fujii T, Nagahori M, Kimura M, Fujioka T, Araki A, Watanabe M. Magnetic resonance evaluation for small bowel strictures in Crohn's disease: comparison with balloon enteroscopy. J Gastroenterol. 2017 Aug;52(8):879-888. doi: 10.1007/s00535-016-1284-z. Epub 2016 Nov 15.
PubMed 27848026Tang L, Huang LY, Cui J, Wu CR. Effect of Double-Balloon Enteroscopy on Diagnosis and Treatment of Small-Bowel Diseases. Chin Med J (Engl). 2018 Jun 5;131(11):1321-1326. doi: 10.4103/0366-6999.232802.
PubMed 29786046
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital
- ClinicalTrials.gov ID
- NCT05470946
- Acronym / sponsor ID
- Diagnostic role of enteroscopy
- Conditions
- Small Intestine Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteroscopy | Other | Device: Double balloon enteroscopyDouble balloon enteroscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double balloon enteroscopyDouble balloon enteroscopy (EN-580T, Fujifilm, Japan) | Device | Enteroscopy |
Primary outcome
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
1 secondary outcome
Side effects and complications of enteroscopy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Background: PubMed 32419915Baggus EMR, Hadjivassiliou M, Cross S, Penny H, Urwin H, Watson S, Woodward JM, Sanders DS. How to manage adult coeliac disease: perspective from the NHS England Rare Diseases Collaborative Network for Non-Responsive and Refractory Coeliac Disease. Frontline Gastroenterol. 2019 Aug 8;11(3):235-242. doi: 10.1136/flgastro-2019-101191. eCollection 2020.
- Background: PubMed 26114907Genta 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.
- Background: PubMed 28513629Ghoshal 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.
- Background: PubMed 27374798ASGE Standards of Practice Committee; Gurudu SR, Bruining DH, Acosta RD, Eloubeidi MA, Faulx AL, Khashab MA, Kothari S, Lightdale JR, Muthusamy VR, Yang J, DeWitt JM. The role of endoscopy in the management of suspected small-bowel bleeding. Gastrointest Endosc. 2017 Jan;85(1):22-31. doi: 10.1016/j.gie.2016.06.013. Epub 2016 Jun 30. No abstract available.
- Background: PubMed 28817113Kamboj AK, Oxentenko AS. Clinical and Histologic Mimickers of Celiac Disease. Clin Transl Gastroenterol. 2017 Aug 17;8(8):e114. doi: 10.1038/ctg.2017.41.
- Background: PubMed 23777610Makkar R, Lopez R, Shen B. Clinical utility of retrograde terminal ileum intubation in the evaluation of chronic non-bloody diarrhea. J Dig Dis. 2013 Oct;14(10):536-42. doi: 10.1111/1751-2980.12082.
- Background: PubMed 35310743Kinoshita Y, Ariyoshi R, Fujigaki S, Tanaka K, Morikawa T, Sanuki T. Endoscopic diagnosis of chronic diarrhea. DEN Open. 2021 Sep 28;2(1):e53. doi: 10.1002/deo2.53. eCollection 2022 Apr.
- Background: PubMed 33776012Mizumoto N, Sasaki Y, Abe Y, Yagi M, Kon T, Onozato Y, Sakai T, Ito M, Umehara M, Ueno Y. Small-bowel Capsule Endoscopic Features in Patients with Eosinophilic Gastroenteritis: Three Case Reports. Intern Med. 2021 Sep 15;60(18):2961-2965. doi: 10.2169/internalmedicine.6935-20. Epub 2021 Mar 29.
- Background: PubMed 28626168Nakano M, Oka S, Tanaka S, Igawa A, Kunihara S, Ueno Y, Ito M, Chayama K. Indications for Small-bowel Capsule Endoscopy in Patients with Chronic Abdominal Pain. Intern Med. 2017;56(12):1453-1457. doi: 10.2169/internalmedicine.56.7458. Epub 2017 Jun 15.
- Background: PubMed 27910801Rowinski SA, Christensen E. Epidemiologic and therapeutic aspects of refractory coeliac disease - a systematic review. Dan Med J. 2016 Dec;63(12):A5307.
- Background: PubMed 28783927Shin JY, Park IS, Bang BW, Kim HK, Shin YW, Kwon KS. A Case of Primary Small Bowel Melanoma Diagnosed by Single-Balloon Enteroscopy. Clin Endosc. 2017 Jul;50(4):395-399. doi: 10.5946/ce.2016.153. Epub 2017 Jun 2.
- Background: PubMed 27848026Takenaka K, Ohtsuka K, Kitazume Y, Matsuoka K, Fujii T, Nagahori M, Kimura M, Fujioka T, Araki A, Watanabe M. Magnetic resonance evaluation for small bowel strictures in Crohn's disease: comparison with balloon enteroscopy. J Gastroenterol. 2017 Aug;52(8):879-888. doi: 10.1007/s00535-016-1284-z. Epub 2016 Nov 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Double balloon enteroscopy in people with Small Intestine Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maiada Ibrahim (01068388643, maiada145@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic role of enteroscopy in small intestinal diseases (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05470946, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.