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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Nada A Mahmoud, Master contact

+201094056956

nadaabualnaga2018@gmail.com

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:

  1. Luminal and brush border processing (e.g Celiac disease, crohn's disease, short bowel syndrome, radiation enteropathy, HIV enteropathy and drug-induced enteropathy).
  2. Absorption into the intestinal mucosa.(e.g Lactose intolerance).
  3. 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).

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 groups in NCT04777682
Study groupRoleWhat they receive
single armOtherA 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.

  1. 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.

  1. First posted2 Mar 2021
  2. Study startJun 2021 (estimated)
  3. Primary completionApr 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

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)
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 28212152
  • Ferro 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 23922469
  • Jeon 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 24143307
  • Keller J, Layer P. The Pathophysiology of Malabsorption. Viszeralmedizin. 2014 Jun;30(3):150-4. doi: 10.1159/000364794.

    PubMed 26288588
  • Xin 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 21620401
  • Lai 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 19136102
  • Nikaki 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 27086887
  • Nylund 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 19294761
  • Panes 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 23583097
  • Pata 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 21331987
  • Prachayakul 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 23800178
  • Tan 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 28433783
  • van 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 27086886
  • Atkinson 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

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.

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