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Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome

Primary Purpose

Malabsorption Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound, double balloon enteroscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malabsorption Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Our study will include all patients referred to our unit with suspected malabsorption syndrome with one or more of the following will be included:

    1. Clinically:

      • Chronic watery, diurnal, and nocturnal, bulky, and frequent diarrhea.
      • Steatorrhea.
      • Abdominal pain and /or distention.
      • Anorexia, nausea, vomiting.
      • 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).
    2. Laboratory: routine blood tests that may reveal anemia, high CRP or low albumin, low calcium, and vitamin D level, high fecal calprotectin.

Exclusion Criteria:

  • Mechanical gastrointestinal obstruction.
  • Pregnant ladies.
  • Those who fail to provide consent.
  • Those unfit for anesthesia (with cardio-pulmonary embarrassment )

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    single arm

    Arm Description

    A single-arm, open, single-center (hospital-based) prospective interventional study to compare intestinal ultrasound versus double balloon enteroscopy in diagnosis of malabsorption syndrome

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2021
    Last Updated
    February 26, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04777682
    Brief Title
    Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome
    Official Title
    Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    April 2023 (Anticipated)
    Study Completion Date
    June 2023 (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
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malabsorption Syndrome

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    single arm
    Arm Type
    Other
    Arm Description
    A single-arm, open, single-center (hospital-based) prospective interventional study to compare intestinal ultrasound versus double balloon enteroscopy in diagnosis of malabsorption syndrome
    Intervention Type
    Procedure
    Intervention Name(s)
    ultrasound, double balloon enteroscopy
    Intervention Description
    compare intestinal ultrasound versus double-balloon enteroscopy in diagnosis of malabsorption syndrome
    Primary Outcome Measure Information:
    Title
    Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome
    Description
    compare between intestinal ultrasound and double balloon enteroscopy in the diagnosis of malabsorption syndrome.
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. 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. Exclusion Criteria: Mechanical gastrointestinal obstruction. Pregnant ladies. Those who fail to provide consent. Those unfit for anesthesia (with cardio-pulmonary embarrassment )
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nada A Mahmoud, Master
    Phone
    +201094056956
    Email
    nadaabualnaga2018@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laila Ab El-Touny, prof
    Organizational Affiliation
    Assuit University, Egypt
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Khaled Ab Khalaf, Dr
    Organizational Affiliation
    Assuit University, Egypt
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sayed Ha Ahmed, Dr
    Organizational Affiliation
    Assuit University, Egypt
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Nada A Mahmoud, Dr
    Organizational Affiliation
    Assuit University, Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28212152
    Citation
    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.
    Results Reference
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    Citation
    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.
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    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.
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    Citation
    Keller J, Layer P. The Pathophysiology of Malabsorption. Viszeralmedizin. 2014 Jun;30(3):150-4. doi: 10.1159/000364794.
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    Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome

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