NCT02275858

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

October 23, 2014

Last Update Submit

March 17, 2016

Conditions

Small Bowel Diseases

Keywords

balloon assisted enteroscopyterminal ileum intubation

Outcome Measures

Primary Outcomes (1)

  • Terminal ileum intubation rate

    Intraoperative

Secondary Outcomes (3)

  • Terminal ileum intubation time for successful intubations

    Intraoperative

  • Small bowel diagnostic rate

    Intraoperative

  • Small bowel intervention rate

    Intraoperative

Other Outcomes (2)

  • Peri-procedural adverse events

    Within the first 24 hours of the procedure

  • Adverse events within the first 7 days

    Between 1-7 days of the procedure

Study Arms (2)

Stiffening wire first

EXPERIMENTAL

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

Device: Stiffening wireDevice: Placebo wire

Placebo wire first

PLACEBO COMPARATOR

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

Device: Stiffening wireDevice: Placebo wire

Interventions

Stiffening wireDEVICE

Stiffening wire

Placebo wire firstStiffening wire first
Placebo wireDEVICE

Placebo wire

Placebo wire firstStiffening wire first

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 14
  • Prior ileocecal surgery, resection, or anastomosis
  • Inability to reach the cecum during retrograde balloon assisted enteroscopy
  • Hemodynamic instability
  • Inpatient procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Center-Victoria Campus

London, Ontario, N6A 5W9, Canada

Location

Related Publications (9)

  • Yamamoto H, Sekine Y, Sato Y, Higashizawa T, Miyata T, Iino S, Ido K, Sugano K. Total enteroscopy with a nonsurgical steerable double-balloon method. Gastrointest Endosc. 2001 Feb;53(2):216-20. doi: 10.1067/mge.2001.112181.

    PMID: 11174299BACKGROUND

  • Yamamoto H, Kita H, Sunada K, Hayashi Y, Sato H, Yano T, Iwamoto M, Sekine Y, Miyata T, Kuno A, Ajibe H, Ido K, Sugano K. Clinical outcomes of double-balloon endoscopy for the diagnosis and treatment of small-intestinal diseases. Clin Gastroenterol Hepatol. 2004 Nov;2(11):1010-6. doi: 10.1016/s1542-3565(04)00453-7.

    PMID: 15551254BACKGROUND

  • May A, Nachbar L, Ell C. Double-balloon enteroscopy (push-and-pull enteroscopy) of the small bowel: feasibility and diagnostic and therapeutic yield in patients with suspected small bowel disease. Gastrointest Endosc. 2005 Jul;62(1):62-70. doi: 10.1016/s0016-5107(05)01586-5.

    PMID: 15990821BACKGROUND

  • Hartmann D, Eickhoff A, Tamm R, Riemann JF. Balloon-assisted enteroscopy using a single-balloon technique. Endoscopy. 2007 Feb;39 Suppl 1:E276. doi: 10.1055/s-2007-966616. Epub 2007 Oct 24. No abstract available.

    PMID: 17957636BACKGROUND

  • Kawamura T, Yasuda K, Tanaka K, Uno K, Ueda M, Sanada K, Nakajima M. Clinical evaluation of a newly developed single-balloon enteroscope. Gastrointest Endosc. 2008 Dec;68(6):1112-6. doi: 10.1016/j.gie.2008.03.1063. Epub 2008 Jul 2.

    PMID: 18599052BACKGROUND

  • ASGE Training Committee 2011-2012; Rajan EA, Pais SA, Degregorio BT, Adler DG, Al-Haddad M, Bakis G, Coyle WJ, Davila RE, Dimaio CJ, Enestvedt BK, Jorgensen J, Lee LS, Mullady DK, Obstein KL, Sedlack RE, Tierney WM, Faulx AL. Small-bowel endoscopy core curriculum. Gastrointest Endosc. 2013 Jan;77(1):1-6. doi: 10.1016/j.gie.2012.09.023.

    PMID: 23261090BACKGROUND

  • 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.

    PMID: 17055868BACKGROUND

  • 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.

    PMID: 17383460BACKGROUND

  • 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.

    PMID: 22912911BACKGROUND

Study Officials

  • Michael Sey, MD

    London Health Sciences Centre-Victoria Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2014

First Posted

October 27, 2014

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 21, 2016

Record last verified: 2016-03

Locations

CA(1)