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.|
|ClinicalTrials.gov 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Recruitment Status : Terminated (SE system by Spirus Medical withdrawn from market in 2011)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
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|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|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|
Single Balloon Enteroscopy
Procedure: Single Balloon
All patients in this group will undergo single balloon enteroscopy
Other Name: Single Balloon Enteroscopy
All patients in this group will undergo Spirus Enteroscopy
Other Name: Spirus Enteroscopy
- 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.
- 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
- 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.
- 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
- A comparison of the mean adjusted diagnostic procedure time [ Time Frame: immediate ]This is calculated by for all procedures: total time minus therapy time.
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): NCT01853241
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Patrick Okolo, MD||Johns Hopkins University|