Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy

Stopped early

Conditions studied: Gastrointestinal Hemorrhage, Inflammatory Bowel Disease, Gastrointestinal Neoplasms

In brief

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.

Key facts

Study ID

NCT01853241

Run by

Johns Hopkins University

People needed

30

Starts

2010-05-01

Expected to finish

2011-01-01

Last updated by the study team

2013-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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