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

February 26, 2021 updated by: Nada Abouelnaga Mahmoud, Assiut University
Our aim is to compare between intestinal ultrasound and double-balloon enteroscopy in the diagnosis of malabsorption syndrome.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: single arm
A single-arm, open, single-center (hospital-based) prospective interventional study to compare intestinal ultrasound versus double balloon enteroscopy in diagnosis of malabsorption syndrome
Procedure: ultrasound, double balloon enteroscopy
compare intestinal ultrasound versus double-balloon enteroscopy in diagnosis of malabsorption syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Laila Ab El-Touny, prof, Assuit university, Egypt
  • Study Director: Khaled Ab Khalaf, Dr, Assuit university, Egypt
  • Study Director: Sayed Ha Ahmed, Dr, Assuit university, Egypt
  • Principal Investigator: Nada A Mahmoud, Dr, Assuit university, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U.S V.S DBE in malabsorption

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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