Enteroscopy Stiffening Device for Retrograde Balloon Assisted Enteroscopy

NCT ID: NCT02275858

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-03-31

Brief Summary

Balloon assisted enteroscopy has revolutionized the management of small bowel diseases by enabling endoscopic access deep into the small bowel. Using a combination of antegrade (through the mouth) and retrograde (through the anus) approaches, a large portion of the small bowel can be examined. Access to the proximal small bowel through the pylorus using the antegrade approach is straightforward but intubating the distal small bowel through the ileocecal valve is challenging due to the flexibility of the enteroscope. Recently, an enteroscopy stiffening wire has been developed. The purpose of our double blind placebo controlled randomized cross over study is to evaluate the performance of the enteroscopy stiffening wire in achieving terminal ileum intubation (TI) during retrograde balloon assisted enteroscopy.

Detailed Description

Small bowel endoscopy has undergone a paradigm shift in the past decade. Prior to this, the small bowel was considered a 'black hole' due to our inability to visualize it endoscopically and the limited sensitivity of radiologic studies. This all changed with the development of video capsule endoscopy, which gave physicians the ability to visualize the full length of the small bowel. Although widely considered a great leap forward, video capsule endoscopy is limited by its inability to perform any form of endoscopic intervention. Thus, something was needed to biopsy and treat the diseases detected with video capsule endoscopy. Double balloon enteroscopy (DBE) was invented in Japan in 2001.(1) Using an overtube and two inflatable balloons, DBE enabled deep intubation of the small bowel through a series of push and pull maneuvers to accordion the small bowel over the overtube. This procedure proved highly successful in the diagnosis and treatment of small bowel diseases.(2, 3) Subsequently, single balloon enteroscopy (SBE) was developed consisting of a single overtube balloon.(4, 5) Collectively, these techniques are called balloon assisted enteroscopy.

Balloon assisted enteroscopy can be performed using an antegrade (through the mouth) or retrograde (through the anus) approach. The two approaches are considered complimentary since the antegrade approach enables visualization of the proximal and mid small bowel while the distal portion is seen with the retrograde approach. Of the two, the retrograde approach is more challenging as it requires first going through the length of the colon followed by intubation of the terminal ileum (TI) to reach the small bowel. TI intubation during balloon assisted enteroscopy can be difficult due to the inherent flexibility of the enteroscope.(6) Even in expert hands, the success rate for TI intubation ranges between 69-79% (7-9) and takes on average 28 minutes to intubate once the cecum has been reached.(8) Patients with distal ileum lesions who fail retrograde balloon assisted enteroscopy have limited options and may require surgery.

Recently, an enteroscopy stiffening wire has been developed by Zutron Medical LLC (Kansas, USA). This is a through the scope wire that stiffens the enteroscope to increase the maximal depth of insertion. Since the difficulty in intubating the TI during retrograde balloon assisted enteroscopy is largely due to the inherent flexibility of the enteroscope, a stiffening wire may improve the ease of TI intubation. The objective of our double blind placebo controlled crossover study is to evaluate the performance of the enteroscopy stiffening wire in improving TI intubation.

Conditions

Small Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Stiffening wire first

This arm will use the stiffening wire first followed by the placebo wire

Group Type: EXPERIMENTAL

Stiffening wire

Intervention Type: DEVICE

Stiffening wire

Placebo wire

Intervention Type: DEVICE

Placebo wire

Placebo wire first

This arm will use the placebo wire first followed by the stiffening wire

Group Type: PLACEBO_COMPARATOR

Stiffening wire

Intervention Type: DEVICE

Stiffening wire

Placebo wire

Intervention Type: DEVICE

Placebo wire

Interventions

Stiffening wire

Stiffening wire

Intervention Type: DEVICE

Placebo wire

Placebo wire

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients undergoing retrograde balloon assisted enteroscopy (either SBE or DBE) for management of small bowel diseases.

Exclusion Criteria

1. Age < 14

2. Prior ileocecal surgery, resection, or anastomosis

3. Inability to reach the cecum during retrograde balloon assisted enteroscopy

4. Hemodynamic instability

5. Inpatient procedure

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Michael Sai Lai Sey, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Sey, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre-Victoria Campus

Locations

London Health Sciences Center-Victoria Campus

London, Ontario, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

PMID: 11174299 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15551254 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 23261090 (View on PubMed)

Mehdizadeh S, Ross A, Gerson L, Leighton J, Chen A, Schembre D, Chen G, Semrad C, Kamal A, Harrison EM, Binmoeller K, Waxman I, Kozarek R, Lo SK. What is the learning curve associated with double-balloon enteroscopy? Technical details and early experience in 6 U.S. tertiary care centers. Gastrointest Endosc. 2006 Nov;64(5):740-50. doi: 10.1016/j.gie.2006.05.022.

Reference Type: BACKGROUND

PMID: 17055868 (View on PubMed)

Mehdizadeh S, Han NJ, Cheng DW, Chen GC, Lo SK. Success rate of retrograde double-balloon enteroscopy. Gastrointest Endosc. 2007 Apr;65(4):633-9. doi: 10.1016/j.gie.2006.12.038.

Reference Type: BACKGROUND

PMID: 17383460 (View on PubMed)

Tee HP, How SH, Kaffes AJ. Learning curve for double-balloon enteroscopy: Findings from an analysis of 282 procedures. World J Gastrointest Endosc. 2012 Aug 16;4(8):368-72. doi: 10.4253/wjge.v4.i8.368.

Reference Type: BACKGROUND

PMID: 22912911 (View on PubMed)

Other Identifiers

HSREB#105974

Identifier Type: -

Identifier Source: org_study_id