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Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01853241
Recruitment Status : Terminated (SE system by Spirus Medical withdrawn from market in 2011)
First Posted : May 14, 2013
Last Update Posted : May 14, 2013
Information provided by (Responsible Party):
Patrick Okolo, MD, Johns Hopkins University

Brief Summary:

The small bowel is poorly suited to standard endoscopy techniques due to its anatomical differences from the colon and the upper gastrointestinal tract. The small bowel has an average length of 6.7 m, with a free mesentery that resists standard "push to advance" endoscopy techniques. New developments in overtubes, which are placed over an enteroscope, have revolutionized doctors ability to deeply intubate the small bowel. Three types of 'augmented' enteroscopy, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE), have been developed. Although studies have been performed on these individual techniques, there are no studies comparing SBE and SE, the two techniques used in Johns Hopkins.

The investigators propose performing a prospective, randomised trial, to assess the differences between these two techniques. The question of what differences there are between these two techniques, in terms of depth of insertion, diagnostic and therapeutic yields, time required for the procedure and the sedation requirements, are important questions to answer, and depending on the results, would affect the investigators approach to patients with small bowel disease.

Condition or disease Intervention/treatment
Gastrointestinal Hemorrhage Inflammatory Bowel Disease Gastrointestinal Neoplasms Procedure: Single Balloon Procedure: Spirus

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy in Patients With Suspected Small Bowel Disease
Study Start Date : May 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Group/Cohort Intervention/treatment
Single balloon
Single Balloon Enteroscopy
Procedure: Single Balloon
All patients in this group will undergo single balloon enteroscopy
Other Name: Single Balloon Enteroscopy

Spirus Enteroscopy
Procedure: Spirus
All patients in this group will undergo Spirus Enteroscopy
Other Name: Spirus Enteroscopy

Primary Outcome Measures :
  1. Comparison of the depth of insertion into the small bowel of SBE compared with SE from the pylorus. [ Time Frame: At the time of procedure ]
    The depth of insertion was defined as the maximum distance the enteroscope was inserted past the pylorus. In SBE, the endoscopist estimates in 10cm increments from 0 to 40 cm the length of small bowel released during each insertion of the overtube and pulling back of the enteroscope and overtube. The net advancement is defined as the DMI for SBE. For SE the DMI is calculated by counting the length of bowel examined in 10-cm increments upon withdrawal of the enteroscope and overtube.

Secondary Outcome Measures :
  1. Comparison of the complication rate between the two techniques. [ Time Frame: 7 days of procedure ]

    Patients were contacted by telephone within 1 week of the procedure. Immediate and short term complications were recorded. Major complications were defined as deep laceration, perforation, significant bleeding requiring blood products, pancreatitis, or hospital admission related to the procedure. Minor complications were defined as mild to moderate mucosal trauma (score 1-3), sore throat less than 72 hours in duration, abdominal discomfort lasting less than 48 hours in duration, or mild nausea or vomiting.

    Mucosal trauma was evaluated upon withdrawal of the enteroscope. Pain was assessed on a 10 point visual analogue scale before and after the procedure. Patients underwent a telephone interview within 7 days of the procedure where the type and severity of side effects and complications were assessed

  2. Comparison of the diagnostic yield between the two techniques. [ Time Frame: immediate ]
    Diagnostic yield was defined as the number of patients who had a diagnosis confirmed with enteroscopy.

  3. Comparison of the therapeutic yield between the two techniques. [ Time Frame: immediate ]
    Therapeutic yield was defined as the number of patients who required a intervention at the time of enteroscopy

  4. A comparison of the mean adjusted diagnostic procedure time [ Time Frame: immediate ]
    This is calculated by for all procedures: total time minus therapy time.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to our center for anterograde augmented enteroscopy for the assessment of suspected small disease

Inclusion Criteria:

  • Age >18 years old
  • Referred to Johns Hopkins Hospital for anterograde augmented enteroscopy to assess for small bowel disease

Exclusion Criteria:

  • Patients who are unable to give informed consent
  • Women who are pregnant
  • Inability to tolerate sedated endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
  • Patients who require retrograde enteroscopy as determined by the principle investigator
  • Patients with altered small bowel anatomy (i.e. Roux-en-Y anastomosis, Bilroth II anatomy)
  • Cirrhosis
  • Esophageal stricture
  • Uncorrected coagulopathy

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 identifier (NCT number): NCT01853241

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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Patrick Okolo, MD Johns Hopkins University

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Responsible Party: Patrick Okolo, MD, Chief, Gastrointestinal Endoscopy; Associate Professor of Medicine, Johns Hopkins University Identifier: NCT01853241    
Other Study ID Numbers: NA_00031000JHU
NA_00031000 ( Other Identifier: Johns Hopkins Medicine )
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013
Keywords provided by Patrick Okolo, MD, Johns Hopkins University:
small intestine
endoscopy, gastrointestinal
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Neoplasms by Site