Malabsorption SyndromeNCT04777682
Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome
A study testing ultrasound, double balloon enteroscopy in people with Malabsorption Syndrome, run by Assiut University.
Trial summary
Our aim is to compare between intestinal ultrasound and double-balloon enteroscopy in the diagnosis of malabsorption syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malabsorption Syndrome
- What is being tested?
- ultrasound, double balloon enteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jun 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Our study will include all patients referred to our unit with suspected malabsorption syndrome with one or more of the following will be included:
- Clinically:
- Chronic watery, diurnal, and nocturnal, bulky, and frequent diarrhea.
- Steatorrhea.
- Abdominal pain and /or distention.
- Anorexia, nausea, vomiting.
Show all 11Show fewer
- Weight loss.
- Anemic manifestations
- Vitamin deficiencies manifestations (e.g Bleeding, bruising, glossitis Peripheral neuropathy) Malnutrition and growth retardation in children.
- Extraintestinal manifestations (e.g Dermatitis herpetiformis, Ankylosing spondylitis, erythema nodosum).
- Laboratory: routine blood tests that may reveal anemia, high CRP or low albumin, low calcium, and vitamin D level, high fecal calprotectin.
Who cannot join
- Mechanical gastrointestinal obstruction.
- Pregnant ladies.
- Those who fail to provide consent.
- Those unfit for anesthesia (with cardio-pulmonary embarrassment )
Trial locations and contacts
No sites are listed yet.
About this study
Our aim is to compare between intestinal ultrasound and double-balloon enteroscopy in the diagnosis of malabsorption syndrome.
Read the detailed description
Malabsorption is impaired absorption of nutrients caused by any disruption in the process of normal absorption. Normal nutrient absorption requires 3 steps:
- Luminal and brush border processing (e.g Celiac disease, crohn's disease, short bowel syndrome, radiation enteropathy, HIV enteropathy and drug-induced enteropathy).
- Absorption into the intestinal mucosa.(e.g Lactose intolerance).
- Transport into the circulation (e.g Primary intestinal lymphangiectasis, secondary obstructions from lymphoma, and infectious causes such as Whipple disease) (van der Heide, 2016).
Malabsorption may be either global or partial (isolated). Global malabsorption results from diseases with diffuse small bowel mucosal involvement or reduced absorptive surface, leading to impaired absorption of almost all nutrients (Keller and Layer, 2014).
Partial or isolated malabsorption results from diseases that interfere with the absorption of specific nutrients (van der Heide, 2016).
Malabsorption disorders are multifactorial, making diagnosis difficult. Symptoms are nonspecific and are frequently mistaken for other conditions, resulting in missed diagnoses . A comprehensive history can often be diagnostic. Several laboratory studies, imaging,and endoscopic evaluations are available to aid in diagnosing malabsorption disorders (Nikaki and Gupte ,2016).
The diagnosis of diseases involving the small bowel is challenging (black box of the gastrointestinal tract) due to the anatomy of this intestinal portion and the lack of tools for proper diagnosis (Jeon and Kim, 2013).
Despite recent advances in technology, endoscopic investigation of the small bowel remains challenging, with imaging techniques now playing an increasingly crucial role in the diagnosis and monitoring of diseases of the small bowel (Nylund et al.,2009).
Although computed tomography(CT)and fluoroscopic studies remain the gold standard investigations, both carry a significant radiation dose, so magnetic resonance imaging(MRI) and ultrasonography(US)are increasingly used as the first-line investigation, especially when imaging patients with inflammatory bowel disease where subsequent repeat imaging to monitor disease activity is useful, but the cumulative radiation dose from CT and fluoroscopic examinations is a concern (Panes et al., 2013).
Intestinal ultrasound has become an important diagnostic tool in the detection of bowel diseases. An advantage of ultrasound imaging compared with endoscopy and contrast radiography is that it permits evaluation of the transmural aspects of inflammatory or neoplastic pathology within its surrounding structures. Other advantages are that it is widely available, noninvasive, can be performed without preparation, and lacks radiation exposure (which may be particularly desirable in patients such as pregnant women) (Atkinson et al., 2017).
On the other hand, important limitations of ultrasonography are that the alimentary tract cannot be visualized over its entire length, many of the findings are nonspecific, and obtaining and interpreting the images is operator-dependent. Furthermore, ultrasound is far less useful in obese patients in whom high-frequency scanning may not be possible (Bryant et al., 2018).
There are three enteroscopy methods currently available: double balloon enteroscopy (DBE), single balloon enteroscopy and spiral enteroscopy. DBE was developed in 2001 by Hironori Yamamoto, and it began to be used in 2004. It enabled the visualization of almost all the bowel, DBE may be performed by anterograde or retrograde way, and the complete enteroscopy can be fulfilled by performing DBE by one extremity (Ferro et al., 2010).
The initial reason for the development of device assisted enteroscopy was the need for better endoscopic access to the small bowel in order to diagnose and/or treat intestinal pathology ( Ching et al.,2017).
Indications for DBE are multiple and are increasingly expanding because the procedure allows, besides the diagnosis of diseases, interventions like biopsies and other therapeutics ( Miranda 2014).
The most common indications for DBE are obscure gastrointestinal bleeding, Crohn's disease and celiac disease ( Ching et al.,2017).
The value of DBE for the surveillance and treatment of hereditary polyposis syndromes is clear ( Beggs et al.,2010).
Therapeutic options of DBE are diverse and comprehend any procedure performed during enteroscopy with diagnostic and curative purpose, including biopsy, polypectomy, argon plasma coagulation (APC), sclerotherapy with adrenaline injection and dilatation with balloon (Gurkan et al.,2013).
Other indications for DBE have since emerged. These new indications can be divided into the following categories: pediatric enteroscopy, DBE-assisted colonoscopy, (Tan et al.,2017) endoscopic access to gastrointestinal segments out of reach of conventional endoscopes and ERCP in patients with altered anatomy ( Cai et al.,2017).
Despite its long duration, DBE is a relatively safe procedure with a complication rate comparable to that of conventional endoscopic procedures ( L. Xin et al.,2011).
The most prevalent major complications are perforation, bleeding, acute pancreatitis and enteritis. Most commonly, there may be minor complications, which include abdominal discomfort and minimal trauma to the intestinal mucosa. It allows the patient to receive medical discharge in the same day ( Pata et al., 2010).
- Conditions
- Malabsorption Syndrome
- Being tested
- ultrasound, double balloon enteroscopy
- Medical subject headings
- Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound, double balloon enteroscopyProcedure or surgery
compare intestinal ultrasound versus double-balloon enteroscopy in diagnosis of malabsorption syndrome
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | A single-arm, open, single-center (hospital-based) prospective interventional study to compare intestinal ultrasound versus double balloon enteroscopy in diagnosis of malabsorption syndrome Receives: Procedure: ultrasound, double balloon enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome
compare between intestinal ultrasound and double balloon enteroscopy in the diagnosis of malabsorption syndrome.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study startJun 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Malabsorption SyndromeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Abouelnaga Mahmoud, Assiut University
- Investigators
- Laila Ab El-Touny, prof, Study chair, Assuit University, EgyptKhaled Ab Khalaf, Dr, Study director, Assuit University, EgyptSayed Ha Ahmed, Dr, Study director, Assuit University, EgyptNada A Mahmoud, Dr, Principal investigator, Assuit University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777682
- Sponsor's protocol ID
- U.S V.S DBE in malabsorption
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ching HL, McAlindon ME, Sidhu R. An update on small bowel endoscopy. Curr Opin Gastroenterol. 2017 May;33(3):181-188. doi: 10.1097/MOG.0000000000000346.
PubMed 28212152Ferro SM de, Correia JM, Pereira AD, Chavez P, Casaca R, Leitão CN. Divertículo de Meckel: diagnóstico por enteroscopia de duplo balão. 2010; 17: 65 - 8.
Gurkan OE, Karakan T, Dogan I, Dalgic B, Unal S. Comparison of double balloon enteroscopy in adults and children. World J Gastroenterol. 2013 Aug 7;19(29):4726-31. doi: 10.3748/wjg.v19.i29.4726.
PubMed 23922469Jeon SR, Kim JO. Deep enteroscopy: which technique will survive? Clin Endosc. 2013 Sep;46(5):480-5. doi: 10.5946/ce.2013.46.5.480. Epub 2013 Sep 30.
PubMed 24143307Keller J, Layer P. The Pathophysiology of Malabsorption. Viszeralmedizin. 2014 Jun;30(3):150-4. doi: 10.1159/000364794.
PubMed 26288588Xin L, Liao Z, Jiang YP, Li ZS. Indications, detectability, positive findings, total enteroscopy, and complications of diagnostic double-balloon endoscopy: a systematic review of data over the first decade of use. Gastrointest Endosc. 2011 Sep;74(3):563-70. doi: 10.1016/j.gie.2011.03.1239. Epub 2011 May 28.
PubMed 21620401Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
PubMed 19136102Nikaki K, Gupte GL. Assessment of intestinal malabsorption. Best Pract Res Clin Gastroenterol. 2016 Apr;30(2):225-35. doi: 10.1016/j.bpg.2016.03.003. Epub 2016 Mar 8.
PubMed 27086887Nylund K, Odegaard S, Hausken T, Folvik G, Lied GA, Viola I, Hauser H, Gilja OH. Sonography of the small intestine. World J Gastroenterol. 2009 Mar 21;15(11):1319-30. doi: 10.3748/wjg.15.1319.
PubMed 19294761Panes J, Bouhnik Y, Reinisch W, Stoker J, Taylor SA, Baumgart DC, Danese S, Halligan S, Marincek B, Matos C, Peyrin-Biroulet L, Rimola J, Rogler G, van Assche G, Ardizzone S, Ba-Ssalamah A, Bali MA, Bellini D, Biancone L, Castiglione F, Ehehalt R, Grassi R, Kucharzik T, Maccioni F, Maconi G, Magro F, Martin-Comin J, Morana G, Pendse D, Sebastian S, Signore A, Tolan D, Tielbeek JA, Weishaupt D, Wiarda B, Laghi A. Imaging techniques for assessment of inflammatory bowel disease: joint ECCO and ESGAR evidence-based consensus guidelines. J Crohns Colitis. 2013 Aug;7(7):556-85. doi: 10.1016/j.crohns.2013.02.020. Epub 2013 Apr 11.
PubMed 23583097Pata C, Akyuz U, Erzin Y, Mercan A. Double-balloon enteroscopy: the diagnosis and management of small bowel diseases. Turk J Gastroenterol. 2010 Dec;21(4):353-9. doi: 10.4318/tjg.2010.0120.
PubMed 21331987Prachayakul V, Deesomsak M, Aswakul P, Leelakusolvong S. The utility of single-balloon enteroscopy for the diagnosis and management of small bowel disorders according to their clinical manifestations: a retrospective review. BMC Gastroenterol. 2013 Jun 22;13:103. doi: 10.1186/1471-230X-13-103.
PubMed 23800178Tan M, Lahiff C, Bassett P, Bailey AA, East JE. Efficacy of Balloon Overtube-Assisted Colonoscopy in Patients With Incomplete or Previous Difficult Colonoscopies: A Meta-analysis. Clin Gastroenterol Hepatol. 2017 Oct;15(10):1628-1630. doi: 10.1016/j.cgh.2017.04.023. Epub 2017 Apr 19. No abstract available.
PubMed 28433783van der Heide F. Acquired causes of intestinal malabsorption. Best Pract Res Clin Gastroenterol. 2016 Apr;30(2):213-24. doi: 10.1016/j.bpg.2016.03.001. Epub 2016 Mar 8.
PubMed 27086886Atkinson NSS, Bryant RV, Dong Y, Maaser C, Kucharzik T, Maconi G, Asthana AK, Blaivas M, Goudie A, Gilja OH, Nuernberg D, Schreiber-Dietrich D, Dietrich CF. How to perform gastrointestinal ultrasound: Anatomy and normal findings. World J Gastroenterol. 2017 Oct 14;23(38):6931-6941. doi: 10.3748/wjg.v23.i38.6931.
PubMed 29097866
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome
- ClinicalTrials.gov ID
- NCT04777682
- Acronym / sponsor ID
- U.S V.S DBE in malabsorption
- Conditions
- Malabsorption Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 2 Mar 2021 (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.
Our aim is to compare between intestinal ultrasound and double-balloon enteroscopy in the diagnosis of malabsorption syndrome.
Detailed description
Malabsorption is impaired absorption of nutrients caused by any disruption in the process of normal absorption. Normal nutrient absorption requires 3 steps:
- Luminal and brush border processing (e.g Celiac disease, crohn's disease, short bowel syndrome, radiation enteropathy, HIV enteropathy and drug-induced enteropathy).
- Absorption into the intestinal mucosa.(e.g Lactose intolerance).
- Transport into the circulation (e.g Primary intestinal lymphangiectasis, secondary obstructions from lymphoma, and infectious causes such as Whipple disease) (van der Heide, 2016).
Malabsorption may be either global or partial (isolated). Global malabsorption results from diseases with diffuse small bowel mucosal involvement or reduced absorptive surface, leading to impaired absorption of almost all nutrients (Keller and Layer, 2014).
Partial or isolated malabsorption results from diseases that interfere with the absorption of specific nutrients (van der Heide, 2016).
Malabsorption disorders are multifactorial, making diagnosis difficult. Symptoms are nonspecific and are frequently mistaken for other conditions, resulting in missed diagnoses . A comprehensive history can often be diagnostic. Several laboratory studies, imaging,and endoscopic evaluations are available to aid in diagnosing malabsorption disorders (Nikaki and Gupte ,2016).
The diagnosis of diseases involving the small bowel is challenging (black box of the gastrointestinal tract) due to the anatomy of this intestinal portion and the lack of tools for proper diagnosis (Jeon and Kim, 2013).
Despite recent advances in technology, endoscopic investigation of the small bowel remains challenging, with imaging techniques now playing an increasingly crucial role in the diagnosis and monitoring of diseases of the small bowel (Nylund et al.,2009).
Although computed tomography(CT)and fluoroscopic studies remain the gold standard investigations, both carry a significant radiation dose, so magnetic resonance imaging(MRI) and ultrasonography(US)are increasingly used as the first-line investigation, especially when imaging patients with inflammatory bowel disease where subsequent repeat imaging to monitor disease activity is useful, but the cumulative radiation dose from CT and fluoroscopic examinations is a concern (Panes et al., 2013).
Intestinal ultrasound has become an important diagnostic tool in the detection of bowel diseases. An advantage of ultrasound imaging compared with endoscopy and contrast radiography is that it permits evaluation of the transmural aspects of inflammatory or neoplastic pathology within its surrounding structures. Other advantages are that it is widely available, noninvasive, can be performed without preparation, and lacks radiation exposure (which may be particularly desirable in patients such as pregnant women) (Atkinson et al., 2017).
On the other hand, important limitations of ultrasonography are that the alimentary tract cannot be visualized over its entire length, many of the findings are nonspecific, and obtaining and interpreting the images is operator-dependent. Furthermore, ultrasound is far less useful in obese patients in whom high-frequency scanning may not be possible (Bryant et al., 2018).
There are three enteroscopy methods currently available: double balloon enteroscopy (DBE), single balloon enteroscopy and spiral enteroscopy. DBE was developed in 2001 by Hironori Yamamoto, and it began to be used in 2004. It enabled the visualization of almost all the bowel, DBE may be performed by anterograde or retrograde way, and the complete enteroscopy can be fulfilled by performing DBE by one extremity (Ferro et al., 2010).
The initial reason for the development of device assisted enteroscopy was the need for better endoscopic access to the small bowel in order to diagnose and/or treat intestinal pathology ( Ching et al.,2017).
Indications for DBE are multiple and are increasingly expanding because the procedure allows, besides the diagnosis of diseases, interventions like biopsies and other therapeutics ( Miranda 2014).
The most common indications for DBE are obscure gastrointestinal bleeding, Crohn's disease and celiac disease ( Ching et al.,2017).
The value of DBE for the surveillance and treatment of hereditary polyposis syndromes is clear ( Beggs et al.,2010).
Therapeutic options of DBE are diverse and comprehend any procedure performed during enteroscopy with diagnostic and curative purpose, including biopsy, polypectomy, argon plasma coagulation (APC), sclerotherapy with adrenaline injection and dilatation with balloon (Gurkan et al.,2013).
Other indications for DBE have since emerged. These new indications can be divided into the following categories: pediatric enteroscopy, DBE-assisted colonoscopy, (Tan et al.,2017) endoscopic access to gastrointestinal segments out of reach of conventional endoscopes and ERCP in patients with altered anatomy ( Cai et al.,2017).
Despite its long duration, DBE is a relatively safe procedure with a complication rate comparable to that of conventional endoscopic procedures ( L. Xin et al.,2011).
The most prevalent major complications are perforation, bleeding, acute pancreatitis and enteritis. Most commonly, there may be minor complications, which include abdominal discomfort and minimal trauma to the intestinal mucosa. It allows the patient to receive medical discharge in the same day ( Pata et al., 2010).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Procedure: ultrasound, double balloon enteroscopyA single-arm, open, single-center (hospital-based) prospective interventional study to compare intestinal ultrasound versus double balloon enteroscopy in diagnosis of malabsorption syndrome |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Our study will include all patients referred to our unit with suspected malabsorption syndrome with one or more of the following will be included:
Key exclusion criteria (4 listed)
- Mechanical gastrointestinal obstruction.
- Pregnant ladies.
- Those who fail to provide consent.
- Those unfit for anesthesia (with cardio-pulmonary embarrassment )
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 |
|---|---|---|
| ultrasound, double balloon enteroscopycompare intestinal ultrasound versus double-balloon enteroscopy in diagnosis of malabsorption syndrome | Procedure or surgery | single arm |
Primary outcome
Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome
Time frame: two years
compare between intestinal ultrasound and double balloon enteroscopy in the diagnosis of malabsorption syndrome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Background: PubMed 28212152Ching HL, McAlindon ME, Sidhu R. An update on small bowel endoscopy. Curr Opin Gastroenterol. 2017 May;33(3):181-188. doi: 10.1097/MOG.0000000000000346.
- BackgroundFerro SM de, Correia JM, Pereira AD, Chavez P, Casaca R, Leitão CN. Divertículo de Meckel: diagnóstico por enteroscopia de duplo balão. 2010; 17: 65 - 8.
- Background: PubMed 23922469Gurkan OE, Karakan T, Dogan I, Dalgic B, Unal S. Comparison of double balloon enteroscopy in adults and children. World J Gastroenterol. 2013 Aug 7;19(29):4726-31. doi: 10.3748/wjg.v19.i29.4726.
- Background: PubMed 24143307Jeon SR, Kim JO. Deep enteroscopy: which technique will survive? Clin Endosc. 2013 Sep;46(5):480-5. doi: 10.5946/ce.2013.46.5.480. Epub 2013 Sep 30.
- Background: PubMed 26288588Keller J, Layer P. The Pathophysiology of Malabsorption. Viszeralmedizin. 2014 Jun;30(3):150-4. doi: 10.1159/000364794.
- Background: PubMed 21620401Xin L, Liao Z, Jiang YP, Li ZS. Indications, detectability, positive findings, total enteroscopy, and complications of diagnostic double-balloon endoscopy: a systematic review of data over the first decade of use. Gastrointest Endosc. 2011 Sep;74(3):563-70. doi: 10.1016/j.gie.2011.03.1239. Epub 2011 May 28.
- Background: PubMed 19136102Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
- Background: PubMed 27086887Nikaki K, Gupte GL. Assessment of intestinal malabsorption. Best Pract Res Clin Gastroenterol. 2016 Apr;30(2):225-35. doi: 10.1016/j.bpg.2016.03.003. Epub 2016 Mar 8.
- Background: PubMed 19294761Nylund K, Odegaard S, Hausken T, Folvik G, Lied GA, Viola I, Hauser H, Gilja OH. Sonography of the small intestine. World J Gastroenterol. 2009 Mar 21;15(11):1319-30. doi: 10.3748/wjg.15.1319.
- Background: PubMed 23583097Panes J, Bouhnik Y, Reinisch W, Stoker J, Taylor SA, Baumgart DC, Danese S, Halligan S, Marincek B, Matos C, Peyrin-Biroulet L, Rimola J, Rogler G, van Assche G, Ardizzone S, Ba-Ssalamah A, Bali MA, Bellini D, Biancone L, Castiglione F, Ehehalt R, Grassi R, Kucharzik T, Maccioni F, Maconi G, Magro F, Martin-Comin J, Morana G, Pendse D, Sebastian S, Signore A, Tolan D, Tielbeek JA, Weishaupt D, Wiarda B, Laghi A. Imaging techniques for assessment of inflammatory bowel disease: joint ECCO and ESGAR evidence-based consensus guidelines. J Crohns Colitis. 2013 Aug;7(7):556-85. doi: 10.1016/j.crohns.2013.02.020. Epub 2013 Apr 11.
- Background: PubMed 21331987Pata C, Akyuz U, Erzin Y, Mercan A. Double-balloon enteroscopy: the diagnosis and management of small bowel diseases. Turk J Gastroenterol. 2010 Dec;21(4):353-9. doi: 10.4318/tjg.2010.0120.
- Background: PubMed 23800178Prachayakul V, Deesomsak M, Aswakul P, Leelakusolvong S. The utility of single-balloon enteroscopy for the diagnosis and management of small bowel disorders according to their clinical manifestations: a retrospective review. BMC Gastroenterol. 2013 Jun 22;13:103. doi: 10.1186/1471-230X-13-103.
- Individual participant dataSharing planned: No
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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.
Laila Ab El-Touny, prof study chair
Assuit University, Egypt
Khaled Ab Khalaf, Dr study director
Assuit University, Egypt
Sayed Ha Ahmed, Dr study director
Assuit University, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound, double balloon enteroscopy in people with Malabsorption Syndrome, 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 11 inclusion and 4 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 2 Mar 2021. 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 Nada A Mahmoud, Master (+201094056956, nadaabualnaga2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome (time frame: two 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 NCT04777682, which also lists 18 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 2 Mar 2021.