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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.
 
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Recruitment Status : Terminated (SE system by Spirus Medical withdrawn from market in 2011)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
Sponsor:
Information provided by (Responsible Party):
Patrick Okolo, MD, Johns Hopkins University

Tracking Information
First Submitted Date May 10, 2013
First Posted Date May 14, 2013
Last Update Posted Date May 14, 2013
Study Start Date May 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2013)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 13, 2013)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy
Official Title Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy in Patients With Suspected Small Bowel Disease
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.

Detailed Description

We currently perform both spiral enteroscopy (SE) and single balloon enteroscopy (SBE) in Johns Hopkins Hospital. The decision as to which procedure to use is determined by the endoscopist performing the procedure, with currently approximately 60% being performed with SE and 40% performed with SBE. We wish to perform a prospective, randomised trial, to assess the differences between these two procedures. 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.

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 the investigators ability to deeply intubate the small bowel. The first of these new techniques to be described was double balloon enteroscopy (DBE) (Fujinon, Wayne, NJ) in 2001. The next development was single balloon enteroscopy (SBE) (Olympus America, Center Valley PA), an iteration of DBE that simply forgoes the second balloon at the tip of the endoscope, and also allows for deep enteroscopy which has been available in the United States since 2007. Spiral enteroscopy (SE) was introduced soon after SBE in 2007, and consists of a spiral overtube (Spirus Medical Inc., Stoughton, Massachusetts, USA) which pleats the small bowel onto the enteroscope.

DBE has the largest amount of published data, with more than 1370 patients and 2591 examinations. Data regarding the efficacy of SBE and SE are more limited than DBE. SBE and SE have only been available in the United States since 2007, and therefore have less published data than DBE. There are two published series of SBE, with several more publications in abstract form. A total of 362 cases have been reported, with diagnostic yields ranging between 30% to 76%, with therapeutic intervention performed in up to 55%. There are 6 reports of SE procedures, with one large series of 1750 cases documenting side effects of SE. The overall diagnostic yield ranged from 24% to 51% with similar treatment success rates. SBE has been compared with DBE in patients with suspected small bowel disease in three studies reported in abstract form. SE has been compared with push enteroscopy and DBE, however there have been no studies comparing SBE and SE.

The risks associated with augmented enteroscopy (DBE, SBE, SE) are similar to those associated with routine endoscopy and include sedation-related complications, aspiration pneumonia, and respiratory infections. In addition, there have been complications specifically related to augmented enteroscopy. Abdominal discomfort can occur due to trapped gas. DBE has been associated with intestinal cramping in 2% to 20% of patients. The use of CO2, which the investigators routinely use in Johns Hopkins, decreases post procedure abdominal cramping. Minor small bowel contusion can occur. The incidence of gastrointestinal haemorrhage does not seem to be increased in augmented enteroscopy compared with standard endoscopic procedures. Pancreatitis occurred in 6 (0.2%) of cases reported in a multicenter United States study of DBE. There have been no reports of pancreatitis associated with SBE or SE enteroscopy. Intestinal perforation is a rare but serious event. Perforation has been reported in 5 (0.2%) of 2591 DBE examinations. In SBE, one perforation was reported in a series of 37 patients, with a case report of a perforation in a patients with jejuna ulceration from metastatic adenocarcinoma of unknown primary. A mucosal tear, requiring endoscopic clip esophageal or gastric perforation, severe bleeding requiring transfusion, cardio-pulmonary arrests or deaths. There were 7 (0.4%) severe complications. Six were small bowel perforations (0.34%).

In Johns Hopkins there has been one perforation using SBE and one using SE one of which occurred in a patient with small bowel Crohns disease (SBE) and the other in a patient with altered anatomy (SE) (personal communication Dr PI Okolo). This latter group of patients are known to be at increased risk of perforation during endoscopic procedures and will be excluded from this study. There have had no other serious complication associated with either SE or SBE enteroscopy. All of the individuals who will participate in this study are already scheduled to have an augmented enteroscopy. Therefore, there is no additional risk incurred by the patient by participating in this study, over and above the risk of an augmented enteroscopy which is part of the routine clinical care for these patients.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients referred to our center for anterograde augmented enteroscopy for the assessment of suspected small disease
Condition
  • Gastrointestinal Hemorrhage
  • Inflammatory Bowel Disease
  • Gastrointestinal Neoplasms
Intervention
  • Procedure: Single Balloon
    All patients in this group will undergo single balloon enteroscopy
    Other Name: Single Balloon Enteroscopy
  • Procedure: Spirus
    All patients in this group will undergo Spirus Enteroscopy
    Other Name: Spirus Enteroscopy
Study Groups/Cohorts
  • Single balloon
    Single Balloon Enteroscopy
    Intervention: Procedure: Single Balloon
  • Spirus
    Spirus Enteroscopy
    Intervention: Procedure: Spirus
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 13, 2013)
30
Original Actual Enrollment Same as current
Actual Study Completion Date January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01853241
Other Study ID Numbers NA_00031000JHU
NA_00031000 ( Other Identifier: Johns Hopkins Medicine )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Patrick Okolo, MD, Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Not Provided
Investigators
Principal Investigator: Patrick Okolo, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date May 2013