Lead investigator/s: A/Prof Britt Christensen, Dr Keri Novak, A/Prof Chris Ma

Investigators across a number of Australian and international sites are working together to validate a novel Intestinal Ultrasound (IUS) Crohn’s Disease activity index and the relative components that make up the scoring system. They will compare IUS with ileocolonoscopy (SES-CD) and magnetic resonance enterography (Simplified MaRIA score) to evaluate CD activity and responsiveness to therapy. This work will help to validate the use of IUS as an important diagnostic and monitoring tool for CD.

Recruitment aim: The study is aiming to recruit 100 patients in total with the aim of approximately 10 per Australian site (plus others overseas).

Australian sites involved: Royal Melbourne Hospital, The Alfred Hospital Melbourne, Mater Hospital Brisbane, The Queen Elizabeth Hospital Adelaide, Sunshine Coast Hospital, St Vincent’s Hospital Melbourne

Who is eligible?

• Patients with Crohn’s disease
• Current objective evidence of inflammation (calprotectin > 250 OR IUS Bowel Wall thickness (BWT) > 3mm)
• About to commence a biologic.

For further information, email Jeni Mitchell (Research Nurse): jeni.mitchell@mh.org.au, Or check out more details here.

Current publications from this work:

1. Novak et al. Expert consensus on optimal acquisition and development of the International Bowel Ultrasound Segmental Activity Score (IBUS-SAS): a reliability and inter-rater variability study on intestinal ultrasonography in Crohn’s Disease. Journal of Crohn’s and Colitis. 2021; 15(4): 609–616

2. Goodsall et al. Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn’s disease. Alimentary Pharmacology & Therapeutics. 2021; 53(8): 873-886

3. Ilvemkar et all. Defining transabdominal Intestinal Ultrasound treatment response and remission in Inflammatory Bowel Disease: Systematic review and expert consensus statement. Journal of Crohn’s and Colitis. 2021. In Press.

Lead investigator/s: Dr Yoon-Kyo An, Dr Rebecca Smith, A/Prof Antony Friedman, A/Prof Jakob Begun

Brief study overview: Acute severe ulcerative colitis (ASUC) occurs in about 20-30% of patients with ulcerative colitis and is a medical emergency often requiring colectomy (30% of patients within 3 months). Endoscopic score has been shown to be a useful predictor of colectomy however is limited by access (delayed theatre availability), only assesses the distal colon and superficial mucosa and generally only assesses inflammation at a single time point. Intestinal ultrasound is a powerful tool to assess transmural disease in real-time and may provide a non-invasive, rapidly available and low-cost alternative.

This study aims to determine the accuracy of intestinal ultrasound findings at presentation for predicting IV steroid therapy failure in patients with ASUC and requirement for rescue therapy or colectomy.

Status: Currently recruiting.

Eligibility criteria:

• Patients 18 and 75 yrs
• Admitted with ASUC (as defined by the Truelove and Witts criteria)
• Requiring IV steroids.

For further information, contact the genius admin admin@genius.health

Lead investigator/s: Ralley Prentice, Emily Wright, Sally Bell, Emma Flannagan, Rimma Goldberg

Brief study overview:

Inflammatory bowel disease affects many women in their child bearing years. Active disease is a primary factor predisposing to adverse pregnancy outcomes and most women will need to be on some form of medication throughout their pregnancy.

This study is looking at IBD during pregnancy and the impact of disease activity and common medications (vedolizumab, ustekinumab and thiopurines (azathioprine, mercaptopurine), on pregnancy outcomes. This study uses IUS as a tool for monitoring disease activity in pregnancy.

Status: Currently recruiting.

Eligibility criteria: 

To be eligible, patients must be

• Aged 18 years or older
• Have a confirmed diagnosis of IBD
• Be refereed be a treating gastroenterologist
• Be pregnant or planning on becoming pregnant in the next 12 months
• Be willing and able to consent to the inventions described

The study leads can offer preconception counselling and drug metabolite monitoring.

To find out more or to refer patients please contact Dr Ralley Prentice MBX_Piccolo@monashhealth.org

Investigators: Zaid Ardalan

Brief study overview:

In symptomatic patients with ileoanal pouches, pouchoscopy is needed for accurate diagnosis but is invasive. This study aimed to assess the utility of non-invasive gastrointestinal ultrasound and fecal calprotectin level in ileoanal pouch patients. The study recruited patients with an ileoanal pouch across clinics in Victoria.

Main conclusions:

At different cut-off values, faecal calprotectin can help rule in or rule out inflammatory pouch disorders with a high degree of sensitivity but cannot differentiate inflammatory pouch disorders. GIUS at different approaches and different cut-off values for bowel wall thickness can help confirm and localise inflammation. Transabdominal GIUS can help rule in and rule out moderate-severe pre-pouch ileitis, and transperineal GIUS can help rule in and rule out pouchitis with a high degree of sensitivity and specificity, reserving pouchoscopies for equivocal cases. Future studies are needed to validate these results and assess the reliability of GIUS and the responsiveness of FC and GIUS to treatment

Further reading:

Ardalan ZS, Friedman AB, Con D, Chandran S, Gibson D, Pham A, De Cruz P, Tay K, Bell S, Rosella O, Sparrow MP, Gibson PR. Accuracy of gastrointestinal ultrasound and calprotectin in the assessment of inflammation and its location in patients with an ileoanal pouch. J Crohns Colitis, 2021, https://doi.org/10.1093/ecco-jcc/jjab125

Investigators: Tom Goodsall, Robert Bryant, Yoon-Kyo An, Jakob Begun, Lauren White, Andrew Lee, Peter Lewindon, Antony Friedman, Emily Wright, Kirstin Taylor, Britt Christensen

Brief study overview: This study was working towards developing and validating an IUS activity index for Crohn’s disease for use in clinical trials and practice

Status: The final validation stage is currently undergoing data analysis and will soon be published.

Further reading:

Goodsall TM, Jairath V, Feagan BG, Parker CE, Nguyen TM, Guizzetti L, et al. Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn’s disease. Alimentary Pharmacology & Therapeutics. 2021;53(8):873-886. doi: 10.1111/apt.16288

Goodsall TM, Nguyen TM, Parker CE, Ma C, Andrews JA, Jairath V, Bryant RV. Systematic Review: Gastrointestinal ultrasound scoring indices for inflammatory bowel disease. J Crohns Colitis. 2020:15(1); 125-42.  DOI:10.1093/ecco-jcc/jjaa129.

Investigators: Tom Goodsall, Robert Bryant

Brief study overview:

The aim of the project is to develop and roll out an online platform of data sharing and storage to facilitate blinded intestinal ultrasound reading and scoring in clinical trials

Status:

Technology is existent and being utilised for current Australian studies. Expressions of interest to Tom Goodsall (tomgoodsall@gmail.com) and Rob Bryant (robert.bryant@sa.gov.au)

Investigators: Rose Vaughan, Britt Christensen, D Tjandra, A Patwardhan, N Mingos, R Gibson, A Boussioutas

Brief study overview: Transmural healing has emerged as a new treatment target and can be assessed non-invasively with intestinal ultrasound (IUS).

The aim of this study was to investigate whether the presence of persistent sonographic changes were associated with clinical complications including medication escalation, corticosteroid use, hospitalization and surgery in CD patients in clinical remission at baseline. The study retrospectively assessed patients with CD who had IUS at a tertiary center.

Main conclusions:

The study found that sonographic inflammation at baseline was associated with increased risk of medical escalation, corticosteroid use, hospitalization and surgery. The study suggests persistent sonographic inflammation can be used as a non-invasive marker of increased risk for clinical complications.

Further reading:

R Vaughan, D Tjandra, A Patwardhan, N Mingos, R Gibson, A Boussioutas, B Christensen, DOP10 Persistent sonographic Inflammation as a predictor of clinical complications in patients with Crohn’s Disease, Journal of Crohn’s and Colitis, Volume 15, Issue Supplement_1, May 2021, Pages S048–S049

Watch this space. Full article to be published soon.