The Role of Small Bowel Ultrasound in Initiation of Infliximab in Crohn's Disease Patients

NCT02330458 | Unknown

• 1 other identifier: Pro00027597
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's Disease.

Conditions

Inflammatory Bowel Disease; Crohn's Disease

Keywords

Inflammatory Bowel Disease; Crohn's disease; Pediatric IBD; small bowel ultrasound; infliximab

Outcome Measures

Primary Outcomes (1)

• Change in bowel wall thickness on small bowel ultrasound (SBUS)

  Change in bowel wall thickness as measured on small bowel ultrasound from ultrasound performed on week 0 to ultrasound performed at week 54. Small Bowel Ultrasound will be performed by a single radiologist using an Acuson S2000 machine with 6 MHz convex and 9 MHz linear array transducers (Siemens, Germany). Participants will be asked to not eat for at least 8 hours prior to the ultrasound, and to drink 500ml of a fluid of their choice just prior to the SBUS, for bowel distension and better visualization. Bowel wall thickness (BWT), the length of any segment of thickened bowel wall \>3mm, hyperemia using doppler, and the presence of free fluid, stricture, intestinal dilation, or enlarged lymph nodes will be documented. Univariate analyses will be performed to determine the association between bowel wall thickness on SBUS, and delta BWT (change in bowel wall thickness week 0 to week 14) and presence of remission at week 54

  1 year

Secondary Outcomes (1)

• Change in stool calprotectin

  1 year

Interventions

Small bowel ultrasound PROCEDURE

Small Bowel Ultrasound will be performed by a single radiologist using an Acuson S2000 machine with 6 MHz convex and 9 MHz linear array transducers (Siemens, Germany). Participants will be asked to not eat for at least 8 hours prior to the ultrasound, and to drink 500ml of a fluid of their choice just prior to the SBUS, for bowel distension and better visualization. Bowel wall thickness (BWT), the length of any segment of thickened bowel wall \>3mm, hyperemia using doppler, and the presence of free fluid, stricture, intestinal dilation, or enlarged lymph nodes will be documented

Eligibility Criteria

• Age: 6 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn's disease involving the small bowel, initiating Infliximab treatment.

You may qualify if:

• Age 6-23 years
• Initiating Infliximab therapy
• Crohns disease involving the distal small bowel +/- proximal colon
• Willingness to undergo SBUS and fecal calprotectin collection prior to starting infliximab and again at week 14 and week 54
• Able to give consent by patient and/or legal guardian

You may not qualify if:

• Ulcerative colitis or non-Crohn's Disease patients
• Lack of small bowel disease
• Patients started on alternative therapy
• Unable or unwilling to provide consent

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (5)

• Moscandrew ME, Loftus EV Jr. Diagnostic advances in inflammatory bowel disease (imaging and laboratory). Curr Gastroenterol Rep. 2009 Dec;11(6):488-95. doi: 10.1007/s11894-009-0074-7.

  PMID: 19903425 BACKGROUND

• Strobel D, Goertz RS, Bernatik T. Diagnostics in inflammatory bowel disease: ultrasound. World J Gastroenterol. 2011 Jul 21;17(27):3192-7. doi: 10.3748/wjg.v17.i27.3192.

  PMID: 21912467 BACKGROUND

• Allen PB, De Cruz P, Lee WK, Taylor S, Desmond PV, Kamm MA. Noninvasive imaging of the small bowel in Crohn's disease: the final frontier. Inflamm Bowel Dis. 2011 Sep;17(9):1987-99. doi: 10.1002/ibd.21598. Epub 2011 Feb 1.

  PMID: 21287661 BACKGROUND

• Fraquelli M, Colli A, Casazza G, Paggi S, Colucci A, Massironi S, Duca P, Conte D. Role of US in detection of Crohn disease: meta-analysis. Radiology. 2005 Jul;236(1):95-101. doi: 10.1148/radiol.2361040799.

  PMID: 15987966 BACKGROUND

• Parente F, Molteni M, Marino B, Colli A, Ardizzone S, Greco S, Sampietro G, Foschi D, Gallus S. Are colonoscopy and bowel ultrasound useful for assessing response to short-term therapy and predicting disease outcome of moderate-to-severe forms of ulcerative colitis?: a prospective study. Am J Gastroenterol. 2010 May;105(5):1150-7. doi: 10.1038/ajg.2009.672. Epub 2009 Dec 8.

  PMID: 19997096 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Namita Singh, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 5, 2015
• Study Start: July 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2018
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

US (1)