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Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02315404
Recruitment Status : Terminated (Poor Enrollment)
First Posted : December 11, 2014
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel.

The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.


Condition or disease Intervention/treatment Phase
Obscure Gastrointestinal Bleeding Procedure: CAP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial
Study Start Date : January 2014
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: No cap
enteroscopy performed without a cap
Procedure: CAP
CAP fitted to the end of the endoscope

Active Comparator: Enteroscopy with a cap
Enteroscopy performed with a CAP fitted to the end of the scope
Procedure: CAP
CAP fitted to the end of the endoscope




Primary Outcome Measures :
  1. Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE). [ Time Frame: 1 day ]

    Diagnostic yield defined as proportion of enteroscopies in which clinically significant findings were identified.

    a. Clinically significant findings being defined as P2 lesion (lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices)



Secondary Outcome Measures :
  1. Overall Diagnostic yield of BAE vs. C-BAE [ Time Frame: 1 day ]

    Diagnostic yield defined as proportion of enteroscopies in which any abnormality is detected.

    a. Abnormalities classified as: i. P0: lesion with no bleeding potential, including visible submucosal veins, diverticula without the presence of blood or nodules without mucosal break.

    ii. P1: lesion considered as having uncertain bleeding potential, such as a red spot on the intestinal mucosa or small erosions.

    iii. P2: lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices


  2. Therapeutic yield BAE vs. Cap assisted BAE (C-BAE). [ Time Frame: 1 day ]
    Therapeutic yield being defined as proportion of enteroscopies in which a therapeutic intervention was undertaken. Interventions included in this calculation were polypectomy, argon plasma coagulation, bipolar coagulation, dilation of strictures, and endoscopic clipping. Biopsy was considered to be a therapeutic intervention if histopathology results lead to the initiation of a medical or surgical therapy (i.e: resection of mass, medical therapy for Crohn's disease)

  3. iii. Depth of small bowel insertion: calculated according to the method of Efthymiou et al. [ Time Frame: 1 day ]
    Fold counting method: The number of complete folds (valvulae conniventes) will be counted during withdrawal of the endoscope; with the assumption that the distance between folds is approximately 0.9 cm.

  4. vProcedure related adverse events. [ Time Frame: 1 day ]
  5. Recurrence of GI bleeding at 12 months, as evaluated by questionnaire [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (≥18 years old) patients undergoing BAE for the evaluation of OGIB or iron deficiency anemia.

Exclusion Criteria:

  • Unable to provide written informed consent.
  • Pregnancy or lactation.
  • Suspected bowel obstruction or GI perforation.
  • Unable to tolerate sedation or general anesthesia due to medical co-morbidities.
  • Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of normal).
  • Patient undergoing retrograde BAE.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315404


Locations
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United States, Missouri
Washington University in St Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02315404     History of Changes
Other Study ID Numbers: SBE CAP 1
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Keywords provided by Washington University School of Medicine:
Obscure gastrointestinal bleeding
Overt gastrointestinal bleeding
Occult gastrointestinal bleeding
Enteroscopy

Additional relevant MeSH terms:
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Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases